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DOR0210017
horse owner’s guide
DORMOSEDAN GEL is a registered trademark of Orion Corporation and is distributed by Pfizer Inc.
©2010 Pfizer Inc. All rights reserved.
N.° NADA 141-306, Aprobado por la FDA
NADA #141-306, Approved by FDA
La imagen siguiente muestra la administración correcta de
Table
cal fie
PRECAUCIÓN:
Do not use DORMOSEDAN GEL in horses with pre-existing atrioventricular (AV) or sinoatrial (SA) blocks, respiratory disease, or chronic
renal failure.
(clorhidrato de detomidina)
Agonista α2 enhydrochloride)
gel para la membrana bucal
(detomidine
Sólo
con
recetaoromucosal
médica gel
-agonist
Alpha
2
Sólo
Rx para
only sedación y sujeción de caballos
For Sedation and Restraint in Horses Only
DESCRIPTION:
INDICACIONES:
INDICATIONS:GEL está indicado para la sedación y sujeción de
DORMOSEDAN
DORMOSEDAN GEL is indicated for sedation and restraint in horses.
equinos.
DOSAGE
AND ADMINISTRATION:
DOSIS
Y ADMINISTRACIÓN:
DORMOSEDAN GEL produces sedation when administered sub-
DORMOSEDAN GEL produce sedación cuando se adminislingually at 0.018 mg/lb (0.040 mg/kg). DORMOSEDAN GEL must
trabepor
vía sublingual
una dosis
0.018 placed
beneath thea tongue
of thedehorse
andmg/lb
is not(0.040 meant mg/kg).
to be
DORMOSEDAN GEL debe aplicarse debajoproduct
de la lengua
delmL
caballo
swallowed.
The
dosing
syringe
delivers
the
in 0.25
iny no
debe tragarse.
La jeringa
el be
producto
incrementos
crements.
The following
dosingdosifica
table may
used to en
determine
the
decorrect
0.25 ml.
Laofsiguiente
tabla con
dosis
dose
DORMOSEDAN
GELlas
(Table
1). recomendadas puede
usarse para determinar la dosis correcta de DORMOSEDAN GEL
Table 1: Sublingual dosing of DORMOSEDAN GEL
(Tabla
1).
Tabla 1: Dosis sublingual de DORMOSEDAN GEL
Approximate
Approximate
body
Range of
body weight
Range of
weight (lb) doses (mg/lb)
(kg)
doses (mg/kg)
0.019–0.017
770–879
0.020–0.017
660–769
250–299
0.021–0.017
550–659
Peso
corporal
330–439
aproximado
(lb)
Peso
corporal
150–199
aproximado
(kg)
Rango
0.023–0.017
de dosis
(mg/lb)
440–549
330–439
440–549
550–659
Usted está pensando:
Esquilado. Herrado. Limpieza de la vaina.
0.022–0.017
0.023–0.017
0.022–0.017
0.021–0.017
0.019–0.017
880–989
200–249
150–199
300–349
200–249
350–399
250–299
400–449
400–449
550–600
880–989
1210–1320 0.019–0.017
0.019–0.017
350–399
500–549
770–879
1100–1209 0.019–0.017
0.019–0.017
300–349
450–499
660–769
0.020–0.017
990–1099
0.019–0.017
Rango
0.051–0.038
de dosis
(mg/kg)
0.047–0-038
0.046–0.038
0.051–0.038
0.044–0.038
0.047–0-038
0.043–0.038
0.046–0.038
0.043–0.038
0.044–0.038
0.042–0.038
0.043–0.038
0.042–0.038
0.043–0.038
0.041–0.038
Dose
volume
(mL)
Volumen
1.00
por dosis
1.25
(ml)
1.50
1.00
1.75
1.25
2.00
1.50
2.25
1.75
2.50
2.00
2.75
2.25
3.00
Use impermeable
gloves when handling
Remove the
sy990–1099
0.019–0.017
450–499the product.
0.042–0.038
2.50
ringe from the outer carton. While holding the plunger, turn the ring-
1100–1209
0.019–0.017
500–549
0.042–0.038
2.75
stop on the plunger
until the ring
is able to slide
freely up and down
the plunger. Position the ring in such a way that the side nearest the
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
barrel is at the desired volume marking. Turn the ring to secure it in
place. Make sure that the horse’s mouth contains no feed. Remove
Él está pensando:
Ah, no, eso no. De ninguna manera. Tienes que estar bromeando.
GuÍA Para propietarios de caballos
CONTRAINDICATIONS:
DORMOSEDAN GEL debajo de la lengua.
Brady
WARNINGS:
DESCRIPCIÓN:
DORMOSEDAN (clorhidrato de detomidina) GEL es un agonista
DORMOSEDAN (detomidine hydrochloride) GEL is a synthetic
sintético
de los adrenorreceptores
, con propiedades
sedantes.
2
agonist with αsedative
properties. Each
mL
alpha 2-adrenoreceptor
Cada
ml
de
DORMOSEDAN
GEL
7.6 mg
de
clorhidrato
of DORMOSEDAN
GEL contains
7.6contiene
mg detomidine
hydrochloride.
de detomidina. El nombre químico es 1H imidazol, clorhidrato
The
chemical
name
is
1H
imidazole,
4-[(2,3-dimethylphenyl)
methyl]4-[(2,3-dimetilfenil)
metil].hydrochloride
El clorhidrato
de detomidina
es una
hydrochloride. Detomidine
is a white,
crystalline, watersoluble substance
having a molecular
weight
222.7.
molecular
sustancia
blanca, cristalina,
soluble en
aguaofcon
un The
peso
molecular
N •HCl and
the structural
is
C12Hfórmula
deformula
222.7.is La
molecular
es Cformula
H N •HCl
y la fórmula
14 2
12 14 2
estructural es
You’re thinking:
DOR0210017
DORMOSEDAN GEL is contraindicated in horses with known hypersensitivity to detomidine. Intravenous potentiated sulfonamides
should not be used in anesthetized or sedated horses as potentially
fatal dysrhythmias may occur.
Secon
LaCAUTION:
ley federal de los Estados Unidos exige que este fármaco sea ad- For sublingual use in horses only. Do not use in horses intended for
Federal law
restricts
this drugmédica
to use by
or onunthe
order of a licenciado.
licensed
ministrado
bajo
prescripción
o por
veterinario
human consumption.
veterinarian.
I don’t think so. No way. You’ve got to be kidding me.
He’s thinking:
Clipping. Shoeing. Sheath cleaning.
Use guantes impermeables al manipular el producto. Retire la jeringa
the
cap
from
the
tip
of
the
syringe
and
save
for
cap
replacement.
del envase exterior. Mientras sostiene el émbolo, gire el anillo dethe
tope
Insert
the
syringe
tip
into
the
horse’s
mouth
from
the
side
of
delmouth,
émbolo
hasta
el anillo
puedathe
deslizarse
hacia
placing
theque
syringe
tip beneath
tongue atlibremente
the level of the
arriba
y abajo del
émbolo.
anillo
de forma
tal que
el lado
commissure
of the
mouth.Coloque
Depress elthe
plunger
until the
ring-stop
contacts
the al
barrel,
depositing
beneath
the tongue.
más
próximo
cilindro
quedethe
enproduct
la marca
del volumen
deseado.
Gire el anillo para fijarlo en su lugar. Asegúrese de que no haya aliThe following picture demonstrates correct administration of
mento
en la boca del animal. Retire el tapón de la punta de la jeringa
DORMOSEDAN GEL beneath the tongue.
y guárdelo para volver a colocarlo. Inserte la punta de la jeringa en
la boca del caballo desde el costado, colocándola por debajo de
la lengua a la altura de la comisura de la boca. Presione el émbolo
hasta que el anillo de tope entre en contacto con el cilindro para
depositar el producto debajo de la lengua.
Clinic
Sweati
Penile
Frequ
HUMAN
for del
human
use. Keep
outa of
the reach
of
Retire laWARNINGS:
jeringa de laNot
boca
caballo,
vuelva
colocar
el tapón
dePiloer
children.
Use
impermeable
drug
la jeringa
y colóquela
en elgloves
envaseduring
externo
paraadministration
desecharla. QuíteseMarke
and during procedures that require contact with the horse’s
los guantes y deséchelos.
mouth. Following sublingual administration of detomidine oromucoFacial/
sal
gel, obtener
drug concentrations
up to 0.072deje
mg/mL
weretiempo
measured
at 30 (por
Para
mejores resultados,
pasar
suficiente
Hyper
minutes
post 40 dose
in equineentre
saliva,
to less than
1% of the
lo menos
minutos)
la equivalent
administración
de DORMOSEDAN
original
concentration
in the gel.En
Mean
drug concentraGEL ydetomidine
el principio
del procedimiento.
general,
los efectos se-Nasal
tions fall to less than 0.010 mg/mL by 2 hours after drug administradantes en el caballo duran de 90 a 180 minutos.
tion, after which a slow decline occurs for several additional hours.
Flatule
Retenga el alimento
y el
hastafollowing
que desaparezcan
lostoefectosMuscl
DORMOSEDAN
GEL can
beagua
absorbed
direct exposure
sedantes
producto.
skin,
eyes ordel
mouth,
and may cause irritation. Skin and mucosal conEpiph
tact with the product should be avoided. Use impermeable gloves
atCONTRAINDICACIONES:
all times.
Pale
GEL
contraindicado
en caballos
con wahipersenInDORMOSEDAN
case of accidental
eyeestá
exposure,
rinse abundantly
with fresh
Swolle
sibilidad
a laexposure,
detomidina.
deben
utilizarse
ter.
In case demostrada
of accidental skin
washNo
with
soap and
water. sulfonamidas potenciadas administradas por vía intravenosa en caballos
Remove
contaminated
clothing.
In a la
anestesiados o sedados ya que pueden producir una arritmia powas s
Appropriate precautions should be taken while handling and using
tencialmente
mortal.
detomi
gel syringes. Accidental exposure could cause adverse reactions,
including
hypotension
bradycardia.
medical
atMild at
No use sedation,
DORMOSEDAN
GELand
en caballos
conSeek
bloqueo
auriculoventention immediately but do not drive because sedation or changes in
of DO
tricular
(AV)
o
sinoauricular
(SA),
enfermedad
respiratoria
o
insufiblood
pressure
occur.
treate
ciencia
renal may
crónica
preexistente.
ataxia
Individuals with cardiovascular disease (for example, hypertension
(0% pl
orADVERTENCIAS:
ischemic heart disease) should take special precautions to avoid
ataxia
exposure
to this
Sólo para
usoproduct.
sublingual en caballos. No usar en caballos destinaDORM
dos al consumo
Caution
should behumano.
exercised when handling sedated horses.
CLINI
Handling or any other sudden stimuli, including noise, may cause a
ADVERTENCIAS PARA HUMANOS: No es apto para uso
defense reaction in an animal that appears to be heavily sedated.
Detom
humano. Mantenga fuera del alcance de los niños. Use guantes
which
Rare cases of human abuse of detomidine products have been reimpermeables
durante
la
administración
del
fármaco
y of
sion
ported.
DORMOSEDAN
GEL should be
managed
to prevent
the risk of con
durante
el procedimiento
que
requiera
el contacto
initially
diversion,
such measures
as restriction
of access and thesublingual
use
la bocathrough
del animal.
Después
de la administración
droppi
of drug accountability procedures appropriate to the clinical setting.
de detomidina en gel para la membrana bucal, se observaron
may c
This ini
concentraciones
de hasta
0.072 mg/ml
a los 30 minutos
The
material safety del
datafármaco
sheet (MSDS)
contains
more detailed
ocde la dosis
en information.
la saliva equina,
equivalentes
a menos
de 1%
la
cupational
safety
To report
adverse reactions
in users
or de marke
periph
toconcentración
obtain a copy oforiginal
the MSDS
for this product
callgel.
1-800-366-5288.
de detomidina
en el
Las concentraciones
ductivi
promedio del fármaco disminuyeron a menos de 0.010 mg/ml
Note to physician: This product contains an alpha 2-adrenoceptor
secon
2 horas después de su administración, después
de
lo
cual
siguió
agonist.
Detom
una leve disminución durante varias horas.
tempe
PRECAUTIONS:
ity due
DORMOSEDAN GEL se puede absorber por exposición directa
cose l
DORMOSEDAN
must ybepuede
placedprovocar
beneath irritación.
the tongueDebe
of the
de la piel, ojosGEL
o boca
evitarse
tion of
horse. Unlike most oral veterinary products, this product is not meant
el contacto de la piel y la mucosa con el producto. Use guantes
salivati
to be swallowed. Swallowing could result in ineffectiveness.
impermeables en todo momento.
penis
DORMOSEDAN GEL does not provide analgesia. Do not use for paintinued
caso de exposición accidental de los ojos, enjuague con abunfulEn
procedures.
the no
dante agua corriente. En caso de contacto accidental con la piel,
eyes,
Do
not use
sedative
drugsla because
the effects may be
lávela
conwith
aguaother
y jabón.
Quítese
ropa contaminada.
additive.
Detom
Deben observarse precauciones adecuadas al manipular y usar
creted
Repeat dosing has not been evaluated.
jeringas con el gel. La exposición accidental puede provocar reacdistrib
reversal
agentsedantes,
with DORMOSEDAN
GEL
The
use ofadversas,
an alpha 2-agonist
ciones
entre otras,
efectos
hipotensión
y bradi1.89 L
has
not been
evaluated.
cardia.
Solicite
ayuda médica inmediatamente pero no conduzca
Detom
porque
puedenany
producirse
efectos
o cambios
en la preBefore
initiating
procedure,
allow sedantes
sedation to
fully develop.
flow (t
sión arterial.
Nervous
or excited horses with high levels of endogenous catecholcleara
amines may exhibit a reduced pharmacological response to alpha 2detomi
Las personas con enfermedad cardiovascular (por ejemplo, hiperadrenoceptor agonists like detomidine. In agitated horses, the oncorrela
tensión o isquemia cardíaca) deben tener cuidados especiales para
set
of
sedative
effects
could
be
slowed,
or
the
depth
and
duration
istratio
la could
exposición
a este producto.
ofevitar
effects
be diminished
or nonexistent. When the product is
First p
administered, the animal should be allowed to rest in a quiet place for
Se deben tener precauciones especiales cuando se manejan casyste
a minimum of 40 minutes.
ballos sedados. La manipulación o cualquier otro estímulo repenDORM
Do
notincluso
use DORMOSEDAN
GELprovocar
in horsesuna
withreacción
cardiovascular
dis- de un
tino,
un ruido, puede
defensiva
Peak c
ease,
respiratory
disorders,
or kidney diseases,
or in conditions
admini
animal
que parezca
estarliver
profundamente
sedado.
of shock, severe debilitation or stress due to extreme heat, cold, faserved
Se han informado casos aislados de abuso en humanos de protigue
or
high
altitude.
Protect
treated
horses
from
temperature
ex40% o
agonists,
potential
for con
tremes.
with
all alpha 2-adrenoceptor
ductosAscon
detomidina.
DORMOSEDAN
GEL the
debe
manejarse
solutio
isolated
cases
hypersensitivity,
including
paradoxical
GEL is
cuidado
para of
evitar
el uso indebido,
con medidas
talesresponse
como restric(excitation),
exists. y el uso de procedimientos de contabilización de los
ción de acceso
EFFE
medicamentos,
indicados
DORMOSEDAN
GEL
has not para
beenentornos
evaluatedclínicos.
in ponies, miniature
horses, or horses younger than one year of age.
DORMOSEDAN GEL es una marca comercial registrada de Orion Corporation y distribuida por
Pfizer Inc. ©2010 Pfizer Inc. Todos los derechos reservados.
DORMOSEDAN GEL has not been evaluated for use in breeding,
pregnant, or lactating horses.
A pros
ducte
GEL p
fully c
9
9
Bloqueo AV de segundo grado
11
Bradicardia (≤ 20 ppm)
12
Relajación del pene
20
Transpiración
DORMOSEDAN GEL
N = 202
Signo clínico
0
0
0
0
0
Placebo
N = 68
Tabla 2: Reacciones adversas (cantidad de caballos) durante
el estudio clínico de campo
En un estudio de campo realizado en Estados Unidos con 270 caballos sedados para facilitar la realización de varios procedimientos
veterinarios y de manejo, se informaron las siguientes reacciones
adversas en 202 caballos tratados con DORMOSEDAN GEL y en
68 caballos tratados con placebo:
Estudio clínico de campo:
REACCIONES ADVERSAS:
DORMOSEDAN GEL no ha sido evaluado en animales para reproducción, preñados o lactantes.
DORMOSEDAN GEL no ha sido evaluado en ponis, caballos miniatura o caballos de menos de un año de edad.
No use DORMOSEDAN GEL en caballos con enfermedad cardiovascular, trastornos respiratorios, enfermedad hepática o renal, o
en condiciones de shock, debilidad grave o estrés provocadas por
exceso de calor, frío, fatiga o altitud elevada. Proteja a los animales
tratados de temperaturas extremas. Al igual que con todos los
agonistas de los adrenorreceptores α2, existe la posibilidad de
casos aislados de hipersensibilidad, incluyendo respuestas
paradójicas (excitación).
Antes de iniciar cualquier procedimiento permita que el fármaco
complete su efecto sedante. Los caballos nerviosos o alterados
con alto nivel de catecolaminas endógenas pueden mostrar
una respuesta farmacológica reducida a los agonistas de los
adrenorreceptores α2, como la detomidina. En caballos agitados,
el inicio del efecto sedante puede demorarse o la intensidad del
efecto puede estar disminuida o no producir ningún efecto. Cuando
se administre el producto, debe permitirse que el animal descanse
en un lugar tranquilo durante 40 minutos por lo menos.
El uso de un agente inhibidor del agonista α2 con DORMOSEDAN
GEL no ha sido evaluado.
La repetición de la dosis no ha sido evaluada.
No use con otras drogas sedantes porque puede generar efectos
adictivos.
DORMOSEDAN GEL no contiene analgésicos. No utilice para practicar procedimientos dolorosos.
DORMOSEDAN GEL debe colocarse debajo de la lengua del caballo. A diferencia de la mayoría de los productos orales de veterinaria, este producto no debe tragarse. Si se traga, es posible que
no produzca efecto.
PRECAUCIONES:
Indicación para el médico: Este producto contiene un agonista
de los adrenorreceptores α2.
La hoja de datos de seguridad del producto (MSDS, por sus siglas
en inglés) contiene información más detallada sobre seguridad profesional. Para comunicar reacciones adversas o solicitar una copia
de la MSDS de este producto, llame al 1-800-366-5288.
EFECTIVIDAD:
El efecto del primer paso hace que una porción muy pequeña del
fármaco llegue a la circulación sistémica si el animal lo traga. El
efecto sedante logrado con DORMOSEDAN GEL se atribuye a la
absorción sublingual del fármaco. Las concentraciones pico se producen aproximadamente 1.83 horas después de la administración
sublingual de DORMOSEDAN GEL. Las concentraciones pico observadas después de la administración de DORMOSEDAN GEL son
de aproximadamente 40% de las observadas después de la inyección intramuscular de detomidina en solución. La biodisponibilidad
absoluta de la detomidina en DORMOSEDAN GEL es 22%.
La detomidina es un fármaco con alta razón de extracción. Las
alteraciones en el flujo sanguíneo hepático (lugar del metabolismo
de la detomidina) pueden modificar la velocidad de eliminación del
fármaco y, en consecuencia, la exposición al mismo. Los efectos
sedantes de la detomidina (considerando la inclinación de la cabeza
como marcador del efecto sedante) están altamente relacionados
con la concentración en sangre, independientemente de la vía de
administración.
La oxidación de la detomidina se produce principalmente en el
hígado. La mayor parte de los metabolitos se excretan con la orina.
La semivida (T½) es de 1 a 2 horas. La detomidina se distribuye
rápidamente; el volumen de distribución (Vd) varía de 0.69 l/kg a
1.89 l/kg. La fijación de las proteínas es de 85% aproximadamente.
La detomidina es un potente agonista no narcótico de los
adrenorreceptores α2 que produce sedación con un efecto central
que inhibe la transmisión de los impulsos nerviosos mediados por
la noradrenalina. La presión arterial aumenta inicialmente debido
a la vasoconstricción periférica y posteriormente desciende a
niveles normales o a niveles levemente inferiores a los normales. La
vasoconstricción puede causar la palidez o el aspecto levemente
cianótico de las membranas mucosas. La respuesta vasopresora
inicial va acompañada de una marcada disminución compensatoria
del ritmo cardíaco mediada por un barorreceptor vagal. El pulso
periférico puede sentirse débil y puede producirse un cambio
transitorio en la conductividad del músculo cardíaco, según
evidencian los bloqueos auriculoventriculares de primer y segundo
grado. Se pueden producir otras arritmias. La detomidina también
puede reducir la frecuencia respiratoria y la temperatura corporal.
La detomidina causa la depresión de la motilidad gastrointestinal
debido a la disminución de la actividad del músculo liso, aumenta
las concentraciones de glucosa en sangre debido a la inhibición
de liberación de insulina y aumenta la producción de orina de 2 a
4 horas después del tratamiento. En algunos caballos se puede
advertir transpiración, salivación y leves temblores musculares.
En sementales y caballos castrados se puede advertir un prolapso
parcial y transitorio del pene. Debido a la permanente posición
gacha del animal sedado, se pueden observar descargas mucosas
de la nariz, con ocasional inflamación de la cabeza, en particular
alrededor de los ojos.
FARMACOLOGÍA CLÍNICA:
Se observó ataxia leve (caballo estable pero con leve balanceo) en
54% de los caballos tratados con DORMOSEDAN GEL y en 4%
de los caballos tratados con placebo a los 40 minutos de administrado el tratamiento. Se observó ataxia moderada en 25% de los
caballos tratados con DORMOSEDAN GEL (0% con placebo) a los
40 minutos de administrado el tratamiento. Continuaba observándose ataxia moderada a marcada a los 90 minutos en el 5% y a los
120 minutos en el 4% de los caballos tratados con DORMOSEDAN
GEL.
En un estudio de laboratorio, se observó eritema transitorio de las
membranas mucosas en 2 (de 8) caballos que recibieron la dosis
recomendada de detomidina en gel.
¿Cómo se administra DORMOSEDAN GEL?
La hoja de datos de seguridad del producto (MSDS, por sus siglas en inglés) contiene información más detallada sobre seguridad profesional. Para informar reacciones adversas en humanos
o equinos, o para obtener la MSDS de este producto, llame al
1-800-366-5288.
En un estudio de seguridad en animales, con dosis múltiple,
DORMOSEDAN GEL se administró durante tres días consecutivos
a 6 caballos por grupo de tratamiento a 0, 1, 3 y 5 veces la dosis de
0.040 mg/kg recomendada en la etiqueta.
SEGURIDAD ANIMAL:
DORMOSEDAN GEL fue administrado correctamente por vía sublingual (debajo de la lengua) en el 97% de los caballos, sin objeción o
con objeción leve.
Se registraron los siguientes índices de éxito con DORMOSEDAN
GEL para el recorte eléctrico del pelo (48%), higiene del prepucio
(81%), limado manual de los dientes (89%), recorte de cascos o colocación de herraduras (86%), colocación de sonda nasogástrica o
endoscopio (80%) o radiografías (74%). Cuarenta minutos después de
la administración de la droga, el 94% de los caballos que recibieron
DORMOSEDAN GEL mostraron efectos de sedación mínimos, moderados o marcados frente al 14% de los caballos tratados con placebo. Todos los caballos tratados con DORMOSEDAN GEL se habían recuperado de la sedación a los 240 minutos de recibido el tratamiento.
* 0: Malo – Gran resistencia. 1: Regular. Resistencia moderada. 2: Bueno.
Cierta resistencia, pero se pudo hacer el procedimiento. 3: Excelente.
El procedimiento se pudo realizar fácilmente con resistencia insignificante.
98
Éxito (puntaje 2 ó 3)
54
3
44
2
15
1
16
0
DORMOSEDAN GEL
N = 129
Puntaje de la capacidad
para realizar el
procedimiento*
3
1
2
1
38
Placebo
N = 42
Tabla 3: Índice de éxito del tratamiento (cantidad de caballos)
por grupo de tratamiento
En el análisis estadístico para evaluar la eficacia se incluyeron ciento
veintinueve caballos tratados con DORMOSEDAN GEL y 42 caballos
tratados con placebo. Se excluyeron del análisis 99 caballos que no
cumplieron los criterios de inclusión o que mostraron desviaciones
importantes del protocolo. El procedimiento veterinario o de manejo
se pudo realizar con éxito en 98 de los 129 caballos tratados con
DORMOSEDAN GEL (76%) pero sólo en 3 de los 42 tratados con
placebo (7%) (Tabla 3). La diferencia entre los dos tratamientos fue
estadísticamente significativa (p = 0.0005).
de 0.040 mg/kg o placebo en gel. Después de recibir el tratamiento,
se evaluó y midió el nivel de sedación de cada caballo, el grado de
ataxia, las pulsaciones, el ritmo cardíaco y la frecuencia respiratoria,
hasta el momento de la recuperación. Después de transcurrido un
período adecuado para permitir la acción sedante, un veterinario
del estudio evaluó y calificó la capacidad para intentar y realizar el
procedimiento veterinario o de manejo.
Hecho en Finlandia
Fecha: 2 de diciembre de 2009
128717US-1
Pfizer Salud Animal
División de Pfizer Inc.
New York, NY 10017
Distribuido por:
Orion Corporation
Turku, Finland
Fabricado por:
El clorhidrato de detomidina puede ser absorbido por su organismo a través de la exposición directa con la piel. En caso de
contacto accidental con la piel, lávela con agua y jabón. Quítese
la ropa contaminada. Comuníquese con su médico si tiene alguna
pregunta o inquietud.
¿Qué debo hacer si el gel entra en contacto con mi piel?
El clorhidrato de detomidina puede ser absorbido por su organismo después de una exposición directa a través de los ojos o la
boca y puede causar irritación en estas zonas. En caso de contacto accidental con los ojos, lávelos con agua durante 15 minutos.
Si la detomidina entra en contacto con las membranas mucosas
de la boca, enjuague sin tragar. En todos los casos de exposición
accidental y posible ingestión, acuda al médico de inmediato. La
exposición accidental al fármaco puede afectarlo y provocarle
síntomas que incluyen somnolencia, baja presión arterial y disminución del ritmo cardíaco. NO CONDUZCA porque la detomidina
pude causar mareo o somnolencia. Comparta la información del
envase con su médico y hágale saber que el producto contiene un
agonista de los adrenorreceptores α2.
¿Qué puede ocurrir si el gel entra en contacto con mis
ojos o boca?
DORMOSEDAN es una marca registrada de Orion Corporation.
Patentes en EE.UU. núm.
Jeringa graduada de 3.0 ml para administración por vía oral,
7.6 mg/ml de clorhidrato de detomidina.
PRESENTACIÓN:
Conserve a temperatura ambiente controlada de 20–25 °C (68–
77 °F), con variaciones permitidas de 15–30 °C (59–86 °F), en el
envase original.
INFORMACIÓN SOBRE CONSERVACIÓN:
Se observaron resultados similares en caballos que recibieron
3 y 5 veces la dosis. En la mayoría de los casos, la incidencia, la
gravedad y la duración del efecto causado se produjeron en función
de la dosis. Todos los resultados de todos los grupos de dosis fueron
representativos de los fármacos adrenorreceptores α2 usados en
caballos.
La dosis recomendada (1 vez) indujo la sedación. La inclinación de
la cabeza produjo un edema transitorio en la zona de la cabeza,
descarga nasal/ocular y congestión de las membranas mucosas de
la boca. Se observó ataxia, transpiración y prolapso reversible del
pene. Se observaron membranas mucosas eritematosas en el lugar
de aplicación de la dosis en 2/6 caballos. Se observó una reducción
transitoria del ritmo cardíaco, la frecuencia respiratoria y la motilidad
intestinal. Los estudios electrocardiográficos revelaron mayor incidencia de arritmias mediadas por el vago (arritmia sinusal, bloqueo
sinusal, bloqueo auriculoventricular de primer y segundo grado) así
como también extrasístole auricular o ventricular en la mayoría de
los caballos. No se asoció ninguna anormalidad clínica con las arritmias transitorias. En casos aislados se observó micción excesiva o
errática.
Si usted tiene o ha tenido antecedentes de enfermedad cardiovascular (por ejemplo, hipertensión o ataque cardíaco) tome precauciones especiales y evite la exposición directa a la jeringa dosificadora. No entre en contacto con la boca ni la saliva de ningún
caballo que haya sido tratado con detomidina en gel durante un
mínimo de dos horas.
Use siempre guantes impermeables al manipular la jeringa dosificadora con clorhidrato de detomidina en gel. Consulte con el
veterinario para saber si los guantes que piensa utilizar son impermeables. Durante las dos horas posteriores a la administración,
use guantes impermeables al realizar cualquier tarea en la que sea
necesario el contacto con la boca del caballo.
¿Cómo debe manejarse el producto?
DORMOSEDAN GEL es un sedante con clorhidrato de detomidina
que actúa sobre la membrana bucal. El veterinario lo receta para
que se puedan llevar a cabo procedimientos en un caballo con
signos de ansiedad. DORMOSEDAN GEL no produce efectos
analgésicos y no debe administrarse para realizar procedimientos
dolorosos.
Al igual que con todos los medicamentos recetados,
DORMOSEDAN GEL debe administrarse al caballo para el que
haya sido recetado. Esta hoja ofrece un resumen informativo acerca de DORMOSEDAN GEL. Si tiene alguna pregunta o inquietud
sobre DORMOSEDAN GEL o los efectos sobre su caballo o sobre
usted mismo, converse con su veterinario.
¿Qué otra cosa debo saber acerca de
DORMOSEDAN GEL?
Después de administrar la dosis adecuada de gel, su caballo debe
permanecer en un lugar tranquilo. A medida que la droga surte
efecto, por lo general se ve que el animal agacha la cabeza y las
patas delanteras adoptan una postura firme. Esto por lo general
toma aproximadamente 40 minutos. También es posible advertir un leve balanceo, transpiración, salivación y leves temblores
musculares. Tenga cuidado cuando maneje caballos sedados.
La manipulación o cualquier otro estímulo repentino, incluso un
ruido, pueden provocar una reacción defensiva de un animal (por
ejemplo, patear), incluso en un caballo que parece estar profundamente sedado. El caballo puede tardar de 3 a 4 horas en recuperarse de la sedación. No suministre alimentos ni agua hasta que
el caballo se haya recuperado.
¿Qué debo esperar después de administrar
DORMOSEDAN GEL?
No vuelva a usar jeringas con dosis parciales. Todo producto no
usado o material de desperdicio debe ser desechado según las
disposiciones locales y las pautas federales para el desecho de
medicamentos con receta. Solicite esta información a su veterinario.
Comuníquese inmediatamente con el médico veterinario que
prescribió el medicamento si la jeringa dosificadora no funciona
adecuadamente durante la administración de la detomidina en gel
y usted piensa que pudo haber administrado medicación de más
o de menos.
Si usted cree que administró la dosis correcta de detomidina en
gel pero su caballo no demuestra una sedación adecuada, comuníquese con el veterinario que prescribió el medicamento. No
repita la dosis.
Si después de 40 minutos la sedación no es la adecuada y
usted sospecha que el caballo tragó o escupió parte del gel, comuníquese con el veterinario que prescribió el medicamento. No
repita la dosis.
permanecer en un lugar tranquilo hasta que se logre la sedación.
¿Qué es DORMOSEDAN GEL?
Este resumen incluye información importante sobre DORMOSEDAN
GEL. Debe leer esta información antes de administrar DORMOSEDAN
GEL a su caballo. Esta guía se ofrece sólo como un resumen y
no reemplaza las instrucciones del veterinario. Converse con su
veterinario si no entiende alguna información incluida o si desea
obtener más información sobre DORMOSEDAN GEL.
La imagen siguiente muestra la forma correcta de administrar
HOJA DE INFORMACIÓN PARA EL CLIENTE SOBRE EL USO Y LA SEGURIDAD DEL PROPIETARIO/OPERARIO
The recommended dose (1X) induced sedation. Head droop caused
Dormosedan Gel should be given according to your veterinarian’s instructions. Your veterinarian will tell you what amount of gel you
should give to your horse. The appropriate dose is delivered beneath
Micción frecuente
How is Dormosedan Gel administered?
In a multiple dose target animal safety study, DORMOSEDAN GEL was
administered on three consecutive days to 6 horses per treatment group
at 0, 1, 3 and 5 times the recommended label dose of 0.040 mg/kg.
As with all prescribed medicines, Dormosedan Gel should only
be given to the horse for which it was prescribed. This sheet provides a summary of information about Dormosedan Gel. If you
have any questions or concerns about Dormosedan Gel or its
effects on your horse or yourself, talk to your veterinarian.
DORMOSEDAN GEL debe administrarse según las indicaciones
del médico veterinario. Su veterinario le dirá qué cantidad de gel
debe administrar a su caballo. La dosis indicada se administra
debajo de la lengua (administración sublingual) y no debe ser
tragada. Verifique que no haya alimentos en la boca del caballo
antes de administrar la medicación.
ANIMAL SAFETY:
What else should I know about Dormosedan Gel?
0
The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in humans
or horses or to obtain an MSDS for this product call 1-800-366-5288.
Following appropriate dosing of the gel, your horse should be kept
in a quiet area. As the drug takes effect, you will typically see the
head lower and the front legs plant in a firm stance. This will usually
take about 40 minutes. You may also notice slight swaying, sweating, salivation and slight muscle tremors. Be careful when handling
sedated horses. Handling or any other sudden stimuli, including
noise, may cause a defense reaction (for example, kicking) even
in a horse that appears to be fully sedated. It may take up to 3–4
hours for the horse to recover from sedation. Withhold food and
water until the horse has recovered.
0
DORMOSEDAN GEL was correctly administered sublingually
(beneath the tongue) in 97% of horses with mild or no objection.
What should I expect after administering Dormosedan
Gel?
4
Detomidine hydrochloride can be absorbed into your body after
direct exposure through the skin. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing.
Contact your physician if you have any questions or concerns.
Do not re-use partial dosing syringes. Any unused product or
waste material should be disposed of in accordance with local requirements and Federal prescription drug disposal guidelines. Ask
your veterinarian for this information.
Piloerección
What if I get the gel on my skin?
Contact your prescribing veterinarian immediately if the dosing syringe fails during the administration of detomidine gel and you are
unsure if too much or too little of the dose was given.
0
Detomidine hydrochloride can be absorbed into your body after direct exposure through the eyes or mouth, and may cause irritation
to these areas. In case of accidental eye exposure, flush with water for 15 minutes. If detomidine is exposed to the mucous membranes of the mouth, rinse without swallowing. In all cases of accidental exposure and possible ingestion, seek medical attention
immediately. Accidental exposure could result in the drug affecting
you, causing symptoms that include sleepiness, low blood pressure and slower heart rate. DO NOT DRIVE, because detomidine
may cause you to feel drowsy or sleepy. Share the package information with your physician and tell the physician that the product
contains an alpha 2-adrenoceptor agonist.
If you believe the correct dose of detomidine gel was administered
but the horse remains inadequately sedated, contact the prescribing veterinarian. Do not repeat the dose.
3
What if I get the gel in my eyes or mouth?
If after 40 minutes there is inadequate sedation and you suspect
that the horse swallowed or spit out some of the gel, contact your
prescribing veterinarian. Do not repeat the dose.
Ataxia marcada
GEL provided sufficient sedation and restraint in horses to successfully conduct procedures requiring administration of a sedative. Two
If you have or have had a history of cardiovascular disease (for
example, hypertension or heart attack) take special precautions
and avoid direct exposure to the dosing syringe. Do not come in
contact with the mouth or any saliva of any horse that was treated
with detomidine gel for a minimum of 2 hours.
in a quiet area until sedation is achieved.
0
The following success rates with DORMOSEDAN GEL were recorded
for electric clipping of hair (48%), cleaning the prepuce (81%), manual
floating of teeth (89%), hoof trimming or shoeing (86%), passage of a
nasogastric tube or endoscope (80%), or radiography (74%). At 40
minutes post dosing, 94% of DORMOSEDAN GEL-treated horses
showed minimal, moderate or marked sedation compared with 14%
of the horses treated with placebo. All DORMOSEDAN GEL-treated
horses had recovered from sedation by 240 minutes post treatment.
Always wear impermeable gloves when handling the dosing syringe
with detomidine hydrochloride gel. Ask the veterinarian whether the
gloves you plan to use are impermeable. For a minimum of 2 hours
after administration, wear impermeable gloves when performing
any tasks that require contact with the horse’s mouth.
3
0
16
38
1
15
1
2
44
2
3
54
1
Success (score 2 or 3)
98
3
* 0: Poor – Strong resistance. 1: Fair. Moderate resistance. 2: Good. Some
resistance, but the procedure could be performed. 3: Excellent. Procedure
could be easily performed with insignificant resistance.
How should the product be handled?
Edema facial/bucal
The following picture demonstrates correct administration of
The followingGEL
picture
demonstrates
DORMOSEDAN
beneath
the tongue.correct administration of
Placebo
N = 42
Dormosedan Gel is an oromucosal sedative containing detomidine hydrochloride. It is prescribed by veterinarians to allow procedures to be done in an anxious horse. Dormosedan Gel has
not been shown to provide analgesia and should not be used for
painful procedures.
0
contacts the barrel, depositing the product beneath the tongue.
DORMOSEDAN GEL
N = 129
What is Dormosedan Gel?
2
Use impermeable gloves when handling the product. Remove the
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
syringe from the outer carton. While holding the plunger, turn the
Use impermeable
glovesuntil
whenthe
handling
product.
Remove
ring-stop
on the plunger
ring isthe
able
to slide
freelythe
upsyand
ringe
the outer
carton.
plunger,
the ringdown
thefrom
plunger.
Position
theWhile
ring holding
in suchthe
a way
that turn
the side
nearstop
on
the
plunger
until
the
ring
is
able
to
slide
freely
up
and
down
est the barrel is at the desired volume marking. Turn the ring to setheit plunger.
the ring
such
a way mouth
that thecontains
side nearest
the
cure
in place.Position
Make sure
thatinthe
horse’s
no feed.
Remove the cap from the tip of the syringe and save for cap replaceplace. Make sure that the horse’s mouth contains no feed. Remove
ment.
Insert the syringe tip into the horse’s mouth from the side of
the cap from the tip of the syringe and save for cap replacement.
the Insert
mouth,
beneath
the from
tongue
the of
level
theplacing
syringethe
tip syringe
into thetip
horse’s
mouth
theatside
theof
the mouth,
commissure
mouth.
Depressthethe
plunger
until
ringplacing of
thethe
syringe
tip beneath
tongue
at the
levelthe
of the
stop
contacts the
depositing
the
product
tongue.
commissure
of barrel,
the mouth.
Depress
the
plungerbeneath
until thethe
ring-stop
Ability to perform the
procedure score*
The following drawing demonstrates correct administration of
Dormosedan Gel beneath the tongue.
Hipersalivación
2.75
Table 3: Treatment success rates (number of horses) by
treatment group
the tongue (sublingually) and is not meant to be swallowed. Make sure
there is no food in the horse’s mouth prior to administration.
0
0.042–0.038
One hundred and twenty-nine DORMOSEDAN GEL-treated and 42
placebo-treated horses were included in the statistical analysis of effectiveness. Ninety-nine horses were excluded from the analysis due
to failure to meet inclusion criteria or due to major protocol deviations.
The veterinary or husbandry procedure was successfully completed
for 98 of 129 DORMOSEDAN GEL-treated horses (76%) but only 3 of
42 placebo-treated horses (7%) (Table 3). The difference between the
two treatments was statistically significant (p=0.0005).
CLIENT INFORMATION SHEET FOR OWNER/HANDLER USE AND SAFETY
This summary contains important information about Dormosedan
Gel. You should read this information before you administer
Dormosedan Gel to your horse. This sheet is provided only as a
summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this
information or if you want to know more about Dormosedan Gel.
2
500–549
A prospective, randomized, masked, multi-center study was conducted to evaluate under field conditions, whether DORMOSEDAN
hundred and seventy client-owned horses of any breed or sex were
sedated to facilitate grooming (including cleaning of the prepuce),
hoof care, floating teeth (manually), passage of a nasogastric tube
or endoscope, or radiography. Horses were enrolled in the study if
they were a yearling or older, in satisfactory body condition, and had
a history of requiring sedation or other means of strong restraint to
enable similar procedures to be carried out. Horses were randomly
assigned to receive DORMOSEDAN GEL sublingually at 0.040 mg/kg
or placebo gel. After administration of treatment, each horse’s level
of sedation, degree of ataxia, heart rate and rhythm, and respiratory
rate were assessed and measured to recovery. After an appropriate
period of time elapsed to allow sedation to develop, a study veterinarian assessed and scored the ability to attempt and to complete the
veterinary or husbandry procedure.
Descarga nasal
0.019–0.017
EFFECTIVENESS:
1
Approximate
Range
Approximate
Range of
Dose
Approximate
Approximate
Dose
body
ofRange
dosesof
body
dosesof
volume
body
bodyweight
weight
Range
volume
weight
(lb)
(mg/lb)
(kg)
(mg/kg)
(mL)
(kg)
doses (mg/kg)
(mL)
330–439
0.023–0.017
150–199
0.051–0.038
1.00
330–439
0.023–0.017
150–199
0.051–0.038
1.00
440–549
0.022–0.017
200–249
0.047–0-038
1.25
440–549
0.022–0.017
200–249
0.047–0-038
1.25
550–659
0.021–0.017
250–299
0.046–0.038
1.50
550–659
0.021–0.017
250–299
0.046–0.038
1.50
660–769
0.020–0.017
300–349
0.044–0.038
1.75
660–769 0.019–0.017
0.020–0.017
300–349
0.044–0.038
1.75
770–879
350–399
0.043–0.038
2.00
770–879 0.019–0.017
0.019–0.017
350–399
0.043–0.038
2.00
880–989
400–449
0.043–0.038
2.25
990–1099
450–499
0.042–0.038
2.50
880–989 0.019–0.017
0.019–0.017
400–449
0.043–0.038
2.25
1100–1209
500–549
0.042–0.038
2.75
990–1099 0.019–0.017
0.019–0.017
450–499
0.042–0.038
2.50
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
12817US-1
Made in Finland
Date: December 2, 2009
1
Table
1: Sublingualdosing
dosingof
of DORMOSEDAN
DORMOSEDAN GEL
Table
1: Sublingual
GEL
Pfizer Animal Health
Div. of Pfizer Inc
New York, NY 10017
Flatulencia
DOSAGE AND ADMINISTRATION:
DORMOSEDAN GEL produces sedation when administered subDORMOSEDAN GEL produces sedation when administered sublingually at 0.018 mg/lb (0.040 mg/kg). DORMOSEDAN GEL must
lingually at 0.018 mg/lb (0.040 mg/kg). DORMOSEDAN GEL must
be be
placed
beneath the tongue of the horse and is not meant to be
placed beneath the tongue of the horse and is not meant to be
swallowed.
The
dosing
productinin0.25
0.25mL
mLin-inswallowed.
The
dosingsyringe
syringe delivers
delivers the
the product
crements.
The
following
used to
todetermine
determinethe
the
crements. The
followingdosing
dosingtable
table may
may be
be used
correct
dose
of of
DORMOSEDAN
(Table1).
1).
correct
dose
DORMOSEDAN GEL
GEL (Table
Dist by:
0
Store at controlled room temperature 20–25°C (68–77°F), with excursions permitted to 15–30°C (59–86°F), in the original package.
1
INDICATIONS:
DORMOSEDAN
GEL is indicated for sedation and restraint in horses.
Warnings:
Clinical field study:
Flatulence
1
0
For sublingual use in horses only. Do not use in horses intended for
In a U.S. field study of 270 horses sedated to facilitate completion of
DORMOSEDAN
GEL can be absorbed following direct exposure to
Muscle tremors
1
1
human consumption.
various veterinary and husbandry procedures, the following adverse
skin, eyes or mouth, and may cause irritation. Skin and mucosal con1
0 DORMOSEDAN
treated with
HUMAN
WARNINGS:
Notbe
foravoided.
human use.
Keep out of the
reach of Epiphorareactions were reported in 202 horses
tact
with the
product should
Use impermeable
gloves
GEL and 68 horses treated with placebo:
at
all times.Use impermeable gloves during drug administration Pale mucous
children.
membranes
1
0
of horses)
during the
In case of accidental eye exposure, rinse abundantly with fresh waSwollen Table
sheath 2: Adverse reactions (number
1
0
mouth.
Following
sublingual
administration
of
detomidine
oromucoclinical field study
ter. In case of accidental skin exposure, wash with soap and water.
sal
gel,
drug
concentrations
up
to
0.072
mg/mL
were
measured
at
30
Remove contaminated clothing.
In a laboratory study, transient erythema of the mucous membranes
minutes post dose in equine saliva, equivalent to less than 1% of thewas seen in 2 (of 8) horses that received the recommended
DORMOSEDAN
GELof
Placebo
dose
Appropriate
precautions
should be taken
and concentrausing
original detomidine
concentration
in thewhile
gel. handling
Mean drug
Clinical
N = 202
N = 68
detomidine
gel. Sign
gel
syringes.
Accidental
exposure
could
cause
adverse
reactions,
tions fall to less than 0.010 mg/mL by 2 hours after drug administraSweating
20
0
including sedation, hypotension and bradycardia. Seek medical attion, after which a slow decline occurs for several additional hours. Mild ataxia (horse stable but swaying slightly) was observed in 54%
tention immediately but do not drive because sedation or changes in
of DORMOSEDAN
GEL-treated horses and in 4% of the
Penile relaxation
12 placebo0
blood
pressure mayGEL
occur.
at 40 minutes post treatment administration. Moderate
DORMOSEDAN
can be absorbed following direct exposuretreated horses
Bradycardia (≤ 20 bpm)
11
0
ataxia was observed in 25% of DORMOSEDAN GEL-treated horses
to
skin,
eyes
or
mouth,
and
may
cause
irritation.
Skin
and
mucoIndividuals with cardiovascular disease (for example, hypertension
Second
AV block
0
(0% placebo)
at degree
40 minutes
post treatment. Moderate 9to marked
salischemic
contactheart
with disease)
the product
should
be avoided.
Use impermeable
or
should
take special
precautions
to avoid
ataxia continued
90 minutes for 5% and to 120 minutes
Frequenttourination
9 for 4% of
0
gloves attoallthis
times.
exposure
product.
DORMOSEDAN GEL-treated horses.
Piloerection
4
0
Caution
should
be exercised
when rinse
handling
sedatedwith
horses.
In case of
accidental
eye exposure,
abundantly
fresh waPHARMACOLOGY:
ataxia
3
0
Handling
or any
other sudden
stimuli,
including
noise,
cause
ter. In case
of accidental
skin
exposure,
wash
withmay
soap
and awater.CLINICALMarked
defense
in an animal
that appears to be heavily sedated.
Detomidine
is a potent
Facial/oral
edemanon-narcotic alpha2-adrenoceptor
3 agonist
0
Removereaction
contaminated
clothing.
which produces sedation with a central effect inhibiting the transmisHypersalivation
2
0
Rare
cases of precautions
human abuseshould
of detomidine
products
have beenand
re- using
Appropriate
be taken
while handling
sion of noradrenalin-mediated nervous impulses. Blood pressure is
ported. DORMOSEDAN GEL should be managed to prevent the risk of
Nasal discharge
2
0
due to peripheral vasoconstriction, subsequently
gel syringes. Accidental exposure could cause adverse reactions,initially increased
diversion, through such measures as restriction of access and the use
normal or slightly below normal levels. Vasoconstriction
including sedation, hypotension and bradycardia. Seek medical at-dropping to
Flatulence
1
0
may
cause
mucous
membranes
to
appear
pale
or
mildly
cyanotic.
tremorsresponse is accompanied by a compensatory
1
1
This initial Muscle
vasopressor
The
material
safety
data
sheet (MSDS) contains more detailed ocblood
pressure
may
occur.
Epiphora in heart rate mediated by a vagal baroreceptor.
1
0
marked decrease
The
cupational safety information. To report adverse reactions in users or
pulse
may membranes
feel weak and a transient change in
Individuals
withof cardiovascular
hypertensionperipheralPale
to
obtain a copy
the MSDS for thisdisease
product(for
call example,
1-800-366-5288.
mucous
1 the con0
or ischemic heart disease) should take special precautions to avoidductivity of the cardiac muscle may occur, as evidenced by first and
Swollenatrioventricular
sheath
0
second degree
blocks. Other arrhythmias 1
may occur.
exposure to this product.
agonist.
Detomidine also decreases the respiratory rate and decreases body
In
a
laboratory
study,
transient
erythema
of
the
mucous
membranes
Caution should be exercised when handling sedated horses.temperature. Detomidine causes depression of gastrointestinal motilwas seen in 2 (of 8) horses that received the recommended dose of
PRECAUTIONS:
Handling or any other sudden stimuli, including noise, may causeity due to decrease in smooth muscle activity, increases blood gludetomidine
gel. of insulin release, and increases produccose levels
due to inhibition
DORMOSEDAN
GEL inmust
be placed
beneath to
thebe
tongue
the
a defense reaction
an animal
that appears
heavilyofsedated.
tion of urine 2 to 4 hours after treatment. In some horses, sweating,
Mild ataxia (horse stable but swaying slightly) was observed in 54% of
to
be swallowed.
Swallowing
could
in ineffectiveness.
Rare
cases of human
abuse
of result
detomidine
products have been re-salivation and slight muscle tremors may be seen. Partial, transient
DORMOSEDAN GEL-treated horses and in 4% of the placebo-treatported. DORMOSEDAN GEL should be managed to prevent the riskpenis prolapse may occur in stallions and geldings. Because of conDORMOSEDAN GEL does not provide analgesia. Do not use for pained horses
40 during
minutes
post treatment
administration.
Moderate
tinued lowering
of theathead
sedation,
mucus discharges
from
of
diversion,
through
such
measures
as
restriction
of
access
and
the
ful procedures.
use of drug accountability procedures appropriate to the clinical setting.the nose with occasional swelling of the head, particularly around the
(0%
placebo) at 40 minutes post treatment. Moderate to marked
eyes, may
be seen.
Do not use with other sedative drugs because the effects may be
ataxia continued to 90 minutes for 5% and to 120 minutes for 4% of
The material safety data sheet (MSDS) contains more detailed ocadditive.
Detomidine is oxidized mainly in the liver. Most metabolites are exGEL-treated horses.
cupational safety information. To report adverse reactions in users orcreted inDORMOSEDAN
the urine. Halflife (T½) is 1–2 hours. Detomidine is rapidly
to obtain a copy of the MSDS for this product call 1-800-366-5288.distributed; volume of distribution (Vd) varies between 0.69 L/kg and
CLINICAL
PHARMACOLOGY:
The use of an alpha 2-agonist reversal agent with DORMOSEDAN GEL
1.89 L/kg.
Protein binding
is about 85%.
has not been evaluated.
Detomidine is a potent non-narcotic alpha -adrenoceptor agonist
agonist.
Detomidine is a high extraction ratio drug. Alterations in 2liver blood
which produces sedation with a central effect inhibiting the transmisBefore initiating any procedure, allow sedation to fully develop.
flow (the site of detomidine metabolism) can change the rate of drug
sion
noradrenalin-mediated
nervous
impulses.
Blood
Nervous
or excited horses with high levels of endogenous catecholclearance
and,ofconsequently,
drug exposure.
The sedative
effects
of pressure is
PRECAUTIONS:
initially
increased
dueastoa peripheral
vasoconstriction,
amines may exhibit a reduced pharmacological response to alpha 2detomidine
(using
head droop
marker for sedation)
are highly subsequently
DORMOSEDAN
GELlike
must
be placed
beneathhorses,
the tongue
dropping
to
normal
or
slightly
below
normal
levels.
Vasoconstriction
adrenoceptor
agonists
detomidine.
In agitated
the on-of thecorrelated
to blood concentration, regardless of the route of adminhorse.
Unlike effects
most could
oral veterinary
thisand
product
set
of sedative
be slowed,products,
or the depth
durationis notistration.may cause mucous membranes to appear pale or mildly cyanotic.
meant
tocould
be swallowed.
Swallowing
could result
ineffectiveness.
of
effects
be diminished
or nonexistent.
When in
the
product is
This initial vasopressor response is accompanied by a compensatory
First pass effect results in a very small portion of drug reaching the
decrease in heart rate mediated by a vagal baroreceptor. The
DORMOSEDAN GEL does not provide analgesia. Do not use forsystemicmarked
circulation if it is swallowed. Sedation achieved with the
peripheral
may feel to
weak
and a drug
transient
change in the conpainful procedures.
DORMOSEDAN
GELpulse
is attributable
sublingual
absorption.
ductivity
of the
cardiac
muscle1.83
mayhours
occur,
as sublingual
evidenced by first and
Do not use DORMOSEDAN GEL in horses with cardiovascular disPeak concentrations
occur
approximately
after
Do not
use withdisorders,
other sedative
drugs diseases,
because or
the
may beadministration
second
atrioventricular
Other arrhythmias
ease,
respiratory
liver or kidney
in effects
conditions
of degree
DORMOSEDAN
GEL. Theblocks.
peak concentrations
ob- may occur.
additive.
Detomidine
also decreases
the respiratory
rate and decreases body
of
shock, severe debilitation or stress due to extreme heat, cold, faserved after
administration
of DORMOSEDAN
GEL are approximately
tigue or high altitude. Protect treated horses from temperature exDetomidine
causes depression
gastrointestinal motil40% of temperature.
those observed
after intramuscular
injection of of
detomidine
RepeatAs
dosing
hasalpha
not been
evaluated.
-adrenoceptor
agonists, the potential for
tremes.
with all
solution.ity
Thedue
absolute
bioavailability
of detomidine
DORMOSEDAN
to decrease
in smooth
muscleinactivity,
increases blood glu2
isolated cases of hypersensitivity, including paradoxical response
GEL
is
22%.
cose
levels
due
to
inhibition
of
insulin
release,
and
increases producThe use of an alpha 2-agonist reversal agent with DORMOSEDAN
(excitation), exists.
GEL has not been evaluated.
EFFECTIVENESS:
salivation and slight muscle tremors may be seen. Partial, transient
DORMOSEDAN GEL has not been evaluated in ponies, miniature
randomized,
study
was conBefore orinitiating
any procedure,
allow
sedation to fully develop.A prospective,
penis prolapse
maymasked,
occur inmulti-center
stallions and
geldings.
Because of conhorses,
horses younger
than one year
of age.
evaluate
underof
field
whether
DORMOSEDAN
Nervous or excited horses with high levels of endogenous catechol-ducted to
tinued
lowering
theconditions,
head during
sedation,
mucus discharges from
STORAGE INFORMATION:
Orion Corporation
Turku, Finland
1
INDICATIONS:
Marked ataxia
3
0
Do not use
DORMOSEDAN
GEL in horses
pre-existing
atrioven- Facial/oral
mouth.
Following
sublingual administration
of with
detomidine
oromucoedema
3
0
pregnant,
or
lactating
horses.
sal
gel, drug
up toblocks,
0.072 mg/mL
were measured
tricular
(AV)concentrations
or sinoatrial (SA)
respiratory
disease, at
or 30
chronic
Hypersalivation
2
0
minutes
post dose in equine saliva, equivalent to less than 1% of the
renal failure.
ADVERSE REACTIONS:
original detomidine concentration in the gel. Mean drug concentraNasal discharge
2
0
tions fall to less than 0.010 mg/mL by 2 hours after drug administra-
Mfd by:
Temblores musculares
DORMOSEDAN (detomidine hydrochloride) GEL is a synthetic alDORMOSEDAN (detomidine hydrochloride) GEL is a synthetic
phaalpha
-adrenoreceptor
agonist
with
sedative
properties.
2
-adrenoreceptor
agonist
with
sedative
properties.Each
EachmL
mLof
2
DORMOSEDAN
GEL GEL
contains
7.6 mg
hydrochloride.
The
of DORMOSEDAN
contains
7.6 detomidine
mg detomidine
hydrochloride.
chemical
name
is
1H
imidazole,
methyl]-hyThe chemical name is 1H imidazole, 4-[(2,3-dimethylphenyl) methyl]drochloride.
Detomidine
hydrochloride
crystalline,waterwaterhydrochloride.
Detomidine
hydrochlorideisisaawhite,
white, crystalline,
soluble
substance
weightofof222.7.
222.7.
The
molecusoluble
substancehaving
havingaamolecular
molecular weight
The
molecular
N2•HCl
and
thethe
structural
formula
is is
formula isisCC1212HH
lar formula
•HCl
and
structural
formula
1414N
2
DORMOSEDAN GEL is a registered trademark of Orion Corporation.
Epífora
DESCRIPTION:
systemic circulation if it is swallowed. Sedation achieved with the
DORMOSEDAN GEL is attributable to sublingual drug absorption. Peak
concentrations occur approximately 1.83 hours after sublingual administration of DORMOSEDAN GEL. The peak concentrations observed
after administration of DORMOSEDAN GEL are approximately 40% of
those observed after intramuscular injection of detomidine solution. The
absolute bioavailability of detomidine in DORMOSEDAN GEL is 22%.
Similar treatment related findings were seen in horses receiving 3X
and 5X doses. In most cases the incidence, severity and duration of
the findings were dose dependent. All findings in all dose groups were
representative of the alpha 2-adrenoreceptor drugs used in horses.
Se realizó un estudio prospectivo, aleatorizado, enmascarado
y multicéntrico para evaluar en condiciones de campo si
DORMOSEDAN GEL ofrece un suficiente efecto sedante y de
sujeción en caballos para realizar con éxito procedimientos en
los que es necesaria la administración de un sedante. Se sedaron
doscientos setenta caballos del cliente, de cualquier raza o sexo,
para facilitar el aseo (incluso la higiene del prepucio), mantenimiento
de los cascos, limado de dientes (manual), colocación de sonda
nasogástrica o endoscopio, o radiografías. Se inscribieron
caballos de un año de edad o más, en estado físico satisfactorio,
y con antecedentes de necesitar sedantes u otro medio fuerte de
sujeción para permitir la realización de procedimientos similares.
Los caballos fueron asignados aleatoriamente al tratamiento con
DORMOSEDAN GEL administrado por vía sublingual a una dosis
DESCRIPTION:
persensitivity to detomidine. Intravenous potentiated sulfonamides
DORMOSEDAN GEL has not been
evaluated in0 ponies, miniature
HUMAN
WARNINGS:
for human use.
Keep outhorses
of the as
reach
of
should not
be used inNot
anesthetized
or sedated
potentially
Piloerection
4
children.
Use impermeable
gloves during drug administration
fatal dysrhythmias
may occur.
U.S. Patent Nos.
0
veterinarian.
3.0 mL graduated oral dosing syringe, 7.6 mg/mL detomidine
hydrochloride.
0
CAUTION:
Federal
law restricts this drug to use by or on the order of a licensed
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
Detomidine is a high extraction ratio drug. Alterations in liver blood flow
(the site of detomidine metabolism) can change the rate of drug clearance and, consequently, drug exposure. The sedative effects of detomidine (using head droop as a marker for sedation) are highly correlated to blood concentration, regardless of the route of administration.
HOW SUPPLIED:
1
CAUTION:
Sweating
Do not use DORMOSEDAN GEL in horses with pre-existing atriovenDo not use DORMOSEDAN GEL20in horses with 0cardiovascular districular
(AV)food
or sinoatrial
(SA) blocks,
Withhold
and water
until therespiratory
sedative disease,
effects or
of chronic
the product
ease, respiratory disorders, liver or12kidney diseases,
Penile relaxation
0 or in conditions of
renal
failure.
wear off.
shock, severe debilitation or stress due to extreme heat, cold, fatigue
11
0
or
high
altitude.
Protect
treated
horses
from
temperature
extremes. As
WARNINGS:
CONTRAINDICATIONS:
Second degree
AV alpha
block 2-adrenoceptor agonists,
9
0 for isolated cases
with
all
the
potential
DORMOSEDAN GEL is contraindicated in horses with known hyof hypersensitivity, including paradoxical response (excitation), exists.
human consumption.
Frequent urination
9
0
Detomidine is oxidized mainly in the liver. Most metabolites are excreted in the urine. Halflife (T½) is 1–2 hours. Detomidine is rapidly
distributed; volume of distribution (Vd) varies between 0.69 L/kg and
1.89 L/kg. Protein binding is about 85%.
transient edema of the head area, nasal/ocular discharge and congestion of oral mucous membranes. Ataxia, sweating and reversible penile
prolapse were observed. Erythematous mucous membranes were seen
at the area of dose application in 2/6 horses. Transient reductions were
seen in heart rate, respiratory rate, and gut motility. Electrocardiography
revealed increased incidences of vagally mediated arrhythmias (sinus
arrhythmia, sinus block, 1st and 2nd degree atrioventricular block) as
well as atrial or ventricular premature beats in the majority of horses. No
clinical abnormalities were associated with the transient arrhythmias.
Excessive or erratic urination were seen in isolated cases.
1
mately 90–180 minutes.
the nose with occasional swelling of the head, particularly around the
eyes, may be seen.
Palidez de las membranas mucosas
(detomidine hydrochloride)
Alpha
-agonisthydrochloride)
oromucosal gel
2
(detomidine
Rx Alpha
only -agonist oromucosal gel
2
ForRx
Sedation
only and Restraint in Horses Only
1100–1209
amines may exhibit a reduced pharmacological response to alpha 2-
Adverse reactions
(number
of horses) during
the cliniCONTRAINDICATIONS:
turn it to the outer carton for disposal. Remove gloves for disposal. Table 2:adrenoceptor
agonists
like detomidine.
In agitated
horses, the onset
cal fieldofstudy
sedative effects could be slowed, or the depth and duration of
DORMOSEDAN GEL is contraindicated in horses with known hyFor the best to
results,
allow adequate
time
(a minimum
of 40 minutes)
persensitivity
detomidine.
Intravenous
potentiated
sulfonamides
effects could be diminished or nonexistent. When the product is adbetween
of DORMOSEDAN
GEL and
beginning the
DORMOSEDAN
GELto rest
Placebo
should
not administration
be used in anesthetized
or sedated horses
as potentially
ministered, the animal should
be allowed
in a quiet place for a
procedure.
In general,
horses show sedative effects lasting approxi- Clinicalminimum
Sign
N = 202
N = 68
fatal
dysrhythmias
may occur.
of 40 minutes.
Vaina hinchada
Take the syringe out of the horse’s mouth, recap the syringe and re-
9
9
11
12
20
Transpiración
DORMOSEDAN GEL
N = 202
Signo clínico
0
0
0
0
0
Placebo
N = 68
adictivos.
no produzca efecto.
PRECAUCIONES:
EFECTIVIDAD:
administración.
GEL.
1-800-366-5288.
SEGURIDAD ANIMAL:
con objeción leve.
98
54
3
44
2
15
1
16
0
DORMOSEDAN GEL
N = 129
para realizar el
procedimiento*
3
1
2
1
38
Placebo
N = 42
Hecho en Finlandia
128717US-1
Pfizer Salud Animal
New York, NY 10017
Distribuido por:
Orion Corporation
Turku, Finland
Fabricado por:
ojos o boca?
PRESENTACIÓN:
envase original.
caballos.
errática.
dolorosos.
DORMOSEDAN GEL?
DORMOSEDAN GEL?
o de menos.
repita la dosis.
repita la dosis.
Micción frecuente
ANIMAL SAFETY:
0
0
Gel?
4
Piloerección
0
3
Ataxia marcada
0
3
0
16
38
1
15
1
2
44
2
3
54
1
98
3
Edema facial/bucal
The followingGEL
picture
demonstrates
DORMOSEDAN
beneath
Placebo
N = 42
painful procedures.
0
DORMOSEDAN GEL
N = 129
2
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
Use impermeable
glovesuntil
whenthe
handling
product.
Remove
ring-stop
on the plunger
ring isthe
able
to slide
freelythe
upsyand
ringe
the outer
carton.
plunger,
the ringdown
thefrom
plunger.
Position
theWhile
ring holding
in suchthe
a way
that turn
the side
nearstop
on
the
plunger
until
the
ring
is
able
to
slide
freely
up
and
down
the ring
such
a way mouth
that thecontains
side nearest
the
cure
in place.Position
Make sure
thatinthe
horse’s
no feed.
ment.
the Insert
mouth,
beneath
the from
tongue
the of
level
theplacing
syringethe
tip syringe
into thetip
horse’s
mouth
theatside
theof
the mouth,
commissure
mouth.
Depressthethe
plunger
until
ringplacing of
thethe
syringe
tip beneath
tongue
at the
levelthe
of the
stop
contacts the
depositing
the
product
tongue.
commissure
of barrel,
the mouth.
Depress
the
plungerbeneath
until thethe
ring-stop
procedure score*
Hipersalivación
2.75
treatment group
0
0.042–0.038
2
500–549
Descarga nasal
0.019–0.017
EFFECTIVENESS:
1
Approximate
Range
Approximate
Range of
Dose
Approximate
Approximate
Dose
body
ofRange
dosesof
body
dosesof
volume
body
bodyweight
weight
Range
volume
weight
(lb)
(mg/lb)
(kg)
(mg/kg)
(mL)
(kg)
doses (mg/kg)
(mL)
330–439
0.023–0.017
150–199
0.051–0.038
1.00
330–439
0.023–0.017
150–199
0.051–0.038
1.00
440–549
0.022–0.017
200–249
0.047–0-038
1.25
440–549
0.022–0.017
200–249
0.047–0-038
1.25
550–659
0.021–0.017
250–299
0.046–0.038
1.50
550–659
0.021–0.017
250–299
0.046–0.038
1.50
660–769
0.020–0.017
300–349
0.044–0.038
1.75
660–769 0.019–0.017
0.020–0.017
300–349
0.044–0.038
1.75
770–879
350–399
0.043–0.038
2.00
770–879 0.019–0.017
0.019–0.017
350–399
0.043–0.038
2.00
880–989
400–449
0.043–0.038
2.25
990–1099
450–499
0.042–0.038
2.50
880–989 0.019–0.017
0.019–0.017
400–449
0.043–0.038
2.25
1100–1209
500–549
0.042–0.038
2.75
990–1099 0.019–0.017
0.019–0.017
450–499
0.042–0.038
2.50
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
12817US-1
Made in Finland
1
Table
1: Sublingualdosing
dosingof
of DORMOSEDAN
DORMOSEDAN GEL
Table
1: Sublingual
GEL
Div. of Pfizer Inc
New York, NY 10017
Flatulencia
be be
placed
swallowed.
The
dosing
productinin0.25
0.25mL
mLin-inswallowed.
The
dosingsyringe
syringe delivers
delivers the
the product
crements.
The
following
used to
todetermine
determinethe
the
crements. The
followingdosing
dosingtable
table may
may be
be used
correct
dose
of of
DORMOSEDAN
(Table1).
1).
correct
dose
DORMOSEDAN GEL
GEL (Table
Dist by:
0
1
INDICATIONS:
DORMOSEDAN
Warnings:
Flatulence
1
0
DORMOSEDAN
Muscle tremors
1
1
human consumption.
0 DORMOSEDAN
treated with
HUMAN
WARNINGS:
Notbe
foravoided.
human use.
Keep out of the
tact
with the
product should
Use impermeable
gloves
at
children.
membranes
1
0
of horses)
during the
1
0
mouth.
Following
sublingual
administration
of
detomidine
sal
gel,
drug
concentrations
up
to
0.072
mg/mL
were
measured
at
30
DORMOSEDAN
GELof
Placebo
dose
Appropriate
precautions
should be taken
and concentrausing
original detomidine
concentration
in thewhile
gel. handling
Mean drug
Clinical
N = 202
N = 68
detomidine
gel. Sign
gel
syringes.
Accidental
exposure
could
cause
adverse
reactions,
20
0
of DORMOSEDAN
Penile relaxation
12 placebo0
blood
pressure mayGEL
occur.
DORMOSEDAN
11
0
to
skin,
eyes
or
mouth,
and
may
cause
irritation.
Skin
and
Second
AV block
0
(0% placebo)
at degree
40 minutes
salischemic
contactheart
with disease)
the product
should
be avoided.
Use impermeable
or
should
take special
precautions
to avoid
ataxia continued
Frequenttourination
9 for 4% of
0
gloves attoallthis
times.
exposure
product.
Piloerection
4
0
Caution
should
be exercised
when rinse
handling
sedatedwith
horses.
In case of
accidental
eye exposure,
abundantly
ataxia
3
0
Handling
or any
other sudden
stimuli,
including
noise,
cause
ter. In case
of accidental
skin
exposure,
wash
withmay
soap
defense
in an animal
Detomidine
is a potent
Facial/oral
3 agonist
0
Removereaction
contaminated
clothing.
2
0
Rare
human abuseshould
of detomidine
products
have beenand
re- using
Appropriate
be taken
while handling
Nasal discharge
2
0
Flatulence
1
0
may
cause
mucous
membranes
to
appear
pale
or
mildly
cyanotic.
1
1
This initial Muscle
vasopressor
The
material
safety
data
pressure
may
occur.
1
0
marked decrease
The
pulse
may membranes
Individuals
to
obtain a copy
product(for
call example,
1-800-366-5288.
mucous
1 the con0
sheath
0
second degree
may occur.
agonist.
In
a
laboratory
study,
transient
erythema
of
the
mucous
membranes
PRECAUTIONS:
due to inhibition
DORMOSEDAN
GEL inmust
be placed
beneath to
thebe
tongue
the
a defense reaction
an animal
that appears
heavilyofsedated.
to
be swallowed.
Swallowing
could
in ineffectiveness.
Rare
cases of human
abuse
of result
detomidine
40 during
minutes
post treatment
administration.
Moderate
tinued lowering
of theathead
sedation,
mucus discharges
from
of
diversion,
through
such
measures
as
restriction
of
access
and
the
ful procedures.
(0%
eyes, may
be seen.
CLINICAL
PHARMACOLOGY:
1.89 L/kg.
Protein binding
is about 85%.
agonist.
sion
nervous
impulses.
Blood
Nervous
and,ofconsequently,
drug exposure.
The sedative
effects
of pressure is
PRECAUTIONS:
initially
increased
dueastoa peripheral
vasoconstriction,
(using
head droop
DORMOSEDAN
GELlike
must
be placed
beneathhorses,
the tongue
dropping
to
normal
or
slightly
below
normal
levels.
Vasoconstriction
adrenoceptor
agonists
detomidine.
In agitated
Unlike effects
most could
oral veterinary
thisand
product
set
of sedative
be slowed,products,
or the depth
meant
tocould
be swallowed.
Swallowing
could result
ineffectiveness.
of
effects
be diminished
or nonexistent.
When in
the
product is
peripheral
may feel to
weak
and a drug
transient
DORMOSEDAN
GELpulse
is attributable
sublingual
absorption.
ductivity
of the
cardiac
muscle1.83
mayhours
occur,
as sublingual
occur
approximately
after
Do not
use withdisorders,
other sedative
drugs diseases,
because or
the
second
atrioventricular
Other arrhythmias
ease,
respiratory
liver or kidney
in effects
conditions
of degree
DORMOSEDAN
GEL. Theblocks.
peak concentrations
ob- may occur.
additive.
Detomidine
also decreases
the respiratory
of
administration
of DORMOSEDAN
causes depression
those observed
after intramuscular
injection of of
detomidine
RepeatAs
dosing
hasalpha
not been
evaluated.
-adrenoceptor
tremes.
with all
solution.ity
Thedue
absolute
bioavailability
of detomidine
DORMOSEDAN
to decrease
in smooth
muscleinactivity,
GEL
is
22%.
cose
levels
due
to
inhibition
of
insulin
release,
and
EFFECTIVENESS:
randomized,
study
any procedure,
allow
penis prolapse
maymasked,
stallions and
geldings.
horses younger
than one year
of age.
evaluate
underof
field
whether
DORMOSEDAN
tinued
lowering
theconditions,
head during
sedation,
Orion Corporation
Turku, Finland
1
INDICATIONS:
Marked ataxia
3
0
Do not use
DORMOSEDAN
GEL in horses
pre-existing
mouth.
Following
of with
detomidine
oromucoedema
3
0
pregnant,
or
lactating
horses.
sal
gel, drug
up toblocks,
0.072 mg/mL
were measured
tricular
(AV)concentrations
or sinoatrial (SA)
respiratory
disease, at
or 30
chronic
Hypersalivation
2
0
minutes
renal failure.
ADVERSE REACTIONS:
2
0
Mfd by:
phaalpha
-adrenoreceptor
agonist
with
sedative
properties.
2
-adrenoreceptor
agonist
with
sedative
properties.Each
EachmL
mLof
2
DORMOSEDAN
GEL GEL
contains
7.6 mg
hydrochloride.
The
of DORMOSEDAN
contains
7.6 detomidine
mg detomidine
hydrochloride.
chemical
name
is
1H
imidazole,
Detomidine
hydrochloride
Detomidine
white, crystalline,
soluble
substance
weightofof222.7.
222.7.
The
molecusoluble
substancehaving
havingaamolecular
molecular weight
The
molecular
N2•HCl
and
thethe
structural
formula
is is
lar formula
•HCl
and
structural
formula
1414N
2
Epífora
DESCRIPTION:
DESCRIPTION:
HUMAN
WARNINGS:
for human use.
Keep outhorses
of the as
reach
of
should not
be used inNot
anesthetized
or sedated
potentially
Piloerection
4
children.
Use impermeable
fatal dysrhythmias
may occur.
U.S. Patent Nos.
0
veterinarian.
hydrochloride.
0
CAUTION:
Federal
veterinarian.
HOW SUPPLIED:
1
CAUTION:
Sweating
(AV)food
or sinoatrial
(SA) blocks,
Withhold
and water
sedative disease,
effects or
of chronic
the product
Penile relaxation
renal
failure.
wear off.
11
0
or
high
altitude.
Protect
treated
horses
from
temperature
extremes. As
WARNINGS:
CONTRAINDICATIONS:
Second degree
AV alpha
9
with
all
the
potential
human consumption.
Frequent urination
9
0
1
eyes, may be seen.
Alpha
oromucosal gel
2
(detomidine
Rx Alpha
2
ForRx
Sedation
1100–1209
Adverse reactions
(number
of horses) during
agonists
like detomidine.
In agitated
horses, the onset
cal fieldofstudy
results,
allow adequate
time
(a minimum
of 40 minutes)
persensitivity
detomidine.
Intravenous
potentiated
sulfonamides
of DORMOSEDAN
GEL and
beginning the
DORMOSEDAN
GELto rest
Placebo
should
not administration
or sedated horses
as potentially
be allowed
procedure.
In general,
Sign
N = 202
N = 68
fatal
dysrhythmias
may occur.
of 40 minutes.
Vaina hinchada
9
9
11
12
20
Transpiración
DORMOSEDAN GEL
N = 202
Signo clínico
0
0
0
0
0
Placebo
N = 68
adictivos.
no produzca efecto.
PRECAUCIONES:
EFECTIVIDAD:
administración.
GEL.
1-800-366-5288.
SEGURIDAD ANIMAL:
con objeción leve.
98
54
3
44
2
15
1
16
0
DORMOSEDAN GEL
N = 129
para realizar el
procedimiento*
3
1
2
1
38
Placebo
N = 42
Hecho en Finlandia
128717US-1
Pfizer Salud Animal
New York, NY 10017
Distribuido por:
Orion Corporation
Turku, Finland
Fabricado por:
ojos o boca?
PRESENTACIÓN:
envase original.
caballos.
errática.
dolorosos.
DORMOSEDAN GEL?
DORMOSEDAN GEL?
o de menos.
repita la dosis.
repita la dosis.
Micción frecuente
ANIMAL SAFETY:
0
0
Gel?
4
Piloerección
0
3
Ataxia marcada
0
3
0
16
38
1
15
1
2
44
2
3
54
1
98
3
Edema facial/bucal
The followingGEL
picture
demonstrates
DORMOSEDAN
beneath
Placebo
N = 42
painful procedures.
0
DORMOSEDAN GEL
N = 129
2
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
Use impermeable
glovesuntil
whenthe
handling
product.
Remove
ring-stop
on the plunger
ring isthe
able
to slide
freelythe
upsyand
ringe
the outer
carton.
plunger,
the ringdown
thefrom
plunger.
Position
theWhile
ring holding
in suchthe
a way
that turn
the side
nearstop
on
the
plunger
until
the
ring
is
able
to
slide
freely
up
and
down
the ring
such
a way mouth
that thecontains
side nearest
the
cure
in place.Position
Make sure
thatinthe
horse’s
no feed.
ment.
the Insert
mouth,
beneath
the from
tongue
the of
level
theplacing
syringethe
tip syringe
into thetip
horse’s
mouth
theatside
theof
the mouth,
commissure
mouth.
Depressthethe
plunger
until
ringplacing of
thethe
syringe
tip beneath
tongue
at the
levelthe
of the
stop
contacts the
depositing
the
product
tongue.
commissure
of barrel,
the mouth.
Depress
the
plungerbeneath
until thethe
ring-stop
procedure score*
Hipersalivación
2.75
treatment group
0
0.042–0.038
2
500–549
Descarga nasal
0.019–0.017
EFFECTIVENESS:
1
Approximate
Range
Approximate
Range of
Dose
Approximate
Approximate
Dose
body
ofRange
dosesof
body
dosesof
volume
body
bodyweight
weight
Range
volume
weight
(lb)
(mg/lb)
(kg)
(mg/kg)
(mL)
(kg)
doses (mg/kg)
(mL)
330–439
0.023–0.017
150–199
0.051–0.038
1.00
330–439
0.023–0.017
150–199
0.051–0.038
1.00
440–549
0.022–0.017
200–249
0.047–0-038
1.25
440–549
0.022–0.017
200–249
0.047–0-038
1.25
550–659
0.021–0.017
250–299
0.046–0.038
1.50
550–659
0.021–0.017
250–299
0.046–0.038
1.50
660–769
0.020–0.017
300–349
0.044–0.038
1.75
660–769 0.019–0.017
0.020–0.017
300–349
0.044–0.038
1.75
770–879
350–399
0.043–0.038
2.00
770–879 0.019–0.017
0.019–0.017
350–399
0.043–0.038
2.00
880–989
400–449
0.043–0.038
2.25
990–1099
450–499
0.042–0.038
2.50
880–989 0.019–0.017
0.019–0.017
400–449
0.043–0.038
2.25
1100–1209
500–549
0.042–0.038
2.75
990–1099 0.019–0.017
0.019–0.017
450–499
0.042–0.038
2.50
1210–1320
0.019–0.017
550–600
0.041–0.038
3.00
12817US-1
Made in Finland
1
Table
1: Sublingualdosing
dosingof
of DORMOSEDAN
DORMOSEDAN GEL
Table
1: Sublingual
GEL
Div. of Pfizer Inc
New York, NY 10017
Flatulencia
be be
placed
swallowed.
The
dosing
productinin0.25
0.25mL
mLin-inswallowed.
The
dosingsyringe
syringe delivers
delivers the
the product
crements.
The
following
used to
todetermine
determinethe
the
crements. The
followingdosing
dosingtable
table may
may be
be used
correct
dose
of of
DORMOSEDAN
(Table1).
1).
correct
dose
DORMOSEDAN GEL
GEL (Table
Dist by:
0
1
INDICATIONS:
DORMOSEDAN
Warnings:
Flatulence
1
0
DORMOSEDAN
Muscle tremors
1
1
human consumption.
0 DORMOSEDAN
treated with
HUMAN
WARNINGS:
Notbe
foravoided.
human use.
Keep out of the
tact
with the
product should
Use impermeable
gloves
at
children.
membranes
1
0
of horses)
during the
1
0
mouth.
Following
sublingual
administration
of
detomidine
sal
gel,
drug
concentrations
up
to
0.072
mg/mL
were
measured
at
30
DORMOSEDAN
GELof
Placebo
dose
Appropriate
precautions
should be taken
and concentrausing
original detomidine
concentration
in thewhile
gel. handling
Mean drug
Clinical
N = 202
N = 68
detomidine
gel. Sign
gel
syringes.
Accidental
exposure
could
cause
adverse
reactions,
20
0
of DORMOSEDAN
Penile relaxation
12 placebo0
blood
pressure mayGEL
occur.
DORMOSEDAN
11
0
to
skin,
eyes
or
mouth,
and
may
cause
irritation.
Skin
and
Second
AV block
0
(0% placebo)
at degree
40 minutes
salischemic
contactheart
with disease)
the product
should
be avoided.
Use impermeable
or
should
take special
precautions
to avoid
ataxia continued
Frequenttourination
9 for 4% of
0
gloves attoallthis
times.
exposure
product.
Piloerection
4
0
Caution
should
be exercised
when rinse
handling
sedatedwith
horses.
In case of
accidental
eye exposure,
abundantly
ataxia
3
0
Handling
or any
other sudden
stimuli,
including
noise,
cause
ter. In case
of accidental
skin
exposure,
wash
withmay
soap
defense
in an animal
Detomidine
is a potent
Facial/oral
3 agonist
0
Removereaction
contaminated
clothing.
2
0
Rare
human abuseshould
of detomidine
products
have beenand
re- using
Appropriate
be taken
while handling
Nasal discharge
2
0
Flatulence
1
0
may
cause
mucous
membranes
to
appear
pale
or
mildly
cyanotic.
1
1
This initial Muscle
vasopressor
The
material
safety
data
pressure
may
occur.
1
0
marked decrease
The
pulse
may membranes
Individuals
to
obtain a copy
product(for
call example,
1-800-366-5288.
mucous
1 the con0
sheath
0
second degree
may occur.
agonist.
In
a
laboratory
study,
transient
erythema
of
the
mucous
membranes
PRECAUTIONS:
due to inhibition
DORMOSEDAN
GEL inmust
be placed
beneath to
thebe
tongue
the
a defense reaction
an animal
that appears
heavilyofsedated.
to
be swallowed.
Swallowing
could
in ineffectiveness.
Rare
cases of human
abuse
of result
detomidine
40 during
minutes
post treatment
administration.
Moderate
tinued lowering
of theathead
sedation,
mucus discharges
from
of
diversion,
through
such
measures
as
restriction
of
access
and
the
ful procedures.
(0%
eyes, may
be seen.
CLINICAL
PHARMACOLOGY:
1.89 L/kg.
Protein binding
is about 85%.
agonist.
sion
nervous
impulses.
Blood
Nervous
and,ofconsequently,
drug exposure.
The sedative
effects
of pressure is
PRECAUTIONS:
initially
increased
dueastoa peripheral
vasoconstriction,
(using
head droop
DORMOSEDAN
GELlike
must
be placed
beneathhorses,
the tongue
dropping
to
normal
or
slightly
below
normal
levels.
Vasoconstriction
adrenoceptor
agonists
detomidine.
In agitated
Unlike effects
most could
oral veterinary
thisand
product
set
of sedative
be slowed,products,
or the depth
meant
tocould
be swallowed.
Swallowing
could result
ineffectiveness.
of
effects
be diminished
or nonexistent.
When in
the
product is
peripheral
may feel to
weak
and a drug
transient
DORMOSEDAN
GELpulse
is attributable
sublingual
absorption.
ductivity
of the
cardiac
muscle1.83
mayhours
occur,
as sublingual
occur
approximately
after
Do not
use withdisorders,
other sedative
drugs diseases,
because or
the
second
atrioventricular
Other arrhythmias
ease,
respiratory
liver or kidney
in effects
conditions
of degree
DORMOSEDAN
GEL. Theblocks.
peak concentrations
ob- may occur.
additive.
Detomidine
also decreases
the respiratory
of
administration
of DORMOSEDAN
causes depression
those observed
after intramuscular
injection of of
detomidine
RepeatAs
dosing
hasalpha
not been
evaluated.
-adrenoceptor
tremes.
with all
solution.ity
Thedue
absolute
bioavailability
of detomidine
DORMOSEDAN
to decrease
in smooth
muscleinactivity,
GEL
is
22%.
cose
levels
due
to
inhibition
of
insulin
release,
and
EFFECTIVENESS:
randomized,
study
any procedure,
allow
penis prolapse
maymasked,
stallions and
geldings.
horses younger
than one year
of age.
evaluate
underof
field
whether
DORMOSEDAN
tinued
lowering
theconditions,
head during
sedation,
Orion Corporation
Turku, Finland
1
INDICATIONS:
Marked ataxia
3
0
Do not use
DORMOSEDAN
GEL in horses
pre-existing
mouth.
Following
of with
detomidine
oromucoedema
3
0
pregnant,
or
lactating
horses.
sal
gel, drug
up toblocks,
0.072 mg/mL
were measured
tricular
(AV)concentrations
or sinoatrial (SA)
respiratory
disease, at
or 30
chronic
Hypersalivation
2
0
minutes
renal failure.
ADVERSE REACTIONS:
2
0
Mfd by:
phaalpha
-adrenoreceptor
agonist
with
sedative
properties.
2
-adrenoreceptor
agonist
with
sedative
properties.Each
EachmL
mLof
2
DORMOSEDAN
GEL GEL
contains
7.6 mg
hydrochloride.
The
of DORMOSEDAN
contains
7.6 detomidine
mg detomidine
hydrochloride.
chemical
name
is
1H
imidazole,
Detomidine
hydrochloride
Detomidine
white, crystalline,
soluble
substance
weightofof222.7.
222.7.
The
molecusoluble
substancehaving
havingaamolecular
molecular weight
The
molecular
N2•HCl
and
thethe
structural
formula
is is
lar formula
•HCl
and
structural
formula
1414N
2
Epífora
DESCRIPTION:
DESCRIPTION:
HUMAN
WARNINGS:
for human use.
Keep outhorses
of the as
reach
of
should not
be used inNot
anesthetized
or sedated
potentially
Piloerection
4
children.
Use impermeable
fatal dysrhythmias
may occur.
U.S. Patent Nos.
0
veterinarian.
hydrochloride.
0
CAUTION:
Federal
veterinarian.
HOW SUPPLIED:
1
CAUTION:
Sweating
(AV)food
or sinoatrial
(SA) blocks,
Withhold
and water
sedative disease,
effects or
of chronic
the product
Penile relaxation
renal
failure.
wear off.
11
0
or
high
altitude.
Protect
treated
horses
from
temperature
extremes. As
WARNINGS:
CONTRAINDICATIONS:
Second degree
AV alpha
9
with
all
the
potential
human consumption.
Frequent urination
9
0
1
eyes, may be seen.
Alpha
oromucosal gel
2
(detomidine
Rx Alpha
2
ForRx
Sedation
1100–1209
Adverse reactions
(number
of horses) during
agonists
like detomidine.
In agitated
horses, the onset
cal fieldofstudy
results,
allow adequate
time
(a minimum
of 40 minutes)
persensitivity
detomidine.
Intravenous
potentiated
sulfonamides
of DORMOSEDAN
GEL and
beginning the
DORMOSEDAN
GELto rest
Placebo
should
not administration
or sedated horses
as potentially
be allowed
procedure.
In general,
Sign
N = 202
N = 68
fatal
dysrhythmias
may occur.
of 40 minutes.
Vaina hinchada
It’s mild. It’s safe. It’s easy to
administer. And it will help you
get everything you need to get
done today. Today.
It’s not a secret. Horses are cautious animals. It’s
in their nature to look at combs and garden hoses
differently than we do. Everything in their world is
something to be questioned, and because of that, the
most routine of procedures such as grooming, shoeing
or sheath cleaning can make them nervous. If you own
a horse, you know that a nervous horse doesn’t always
stand still. That means any routine procedure can take
twice as long to finish.
Prescribed by your veterinarian, DORMOSEDAN GEL®
(detomidine hydrochloride) is a safe, effective way for
you to administer a mild, standing sedative based on
your veterinarian’s guidance. Available in single-dose
needleless syringes, this FDA-approved oral gel formulation can only be obtained through a veterinary
prescription from your horse’s veterinarian, but it will
still give you the freedom to use it if needed.
Convenient and safe for a wide
variety of procedures.
You know your horse better than anyone. Not every horse owner
needs DORMOSEDAN GEL® for every procedure. But for those
occasions when your horse won’t cooperate, DORMOSEDAN GEL is
an easy-to-use option for needle-shy horses and any horse owner
who is uncomfortable giving an injection. It’s administered from a
single-dose syringe underneath the tongue, so dosing is simplified
and there’s no hassle with needles. Not only is it a safe alternative to
physical restraint, it’s more effective and more predictable than other
methods. It delivers consistent results for your horse each time it’s used.
Use DORMOSEDAN GEL prior to stressful situations and minor,
husbandry (nonpainful) procedures, including:
•Shoeing
•Body clipping
•Bridle path trimming
•Mane pulling
•Sheath cleaning
•First time turnouts for fractious horses
It’s important to withhold food and water until the sedative effect
of the product has worn off. When used prior to first time turnouts,
supervise horse to prevent grazing until the sedative has worn off.
Convenient and safe for a wide
variety of procedures.
You know your horse better than anyone. Not every horse owner
needs DORMOSEDAN GEL® for every procedure. But for those
occasions when your horse won’t cooperate, DORMOSEDAN GEL is
an easy-to-use option for needle-shy horses and any horse owner
who is uncomfortable giving an injection. It’s administered from a
single-dose syringe underneath the tongue, so dosing is simplified
and there’s no hassle with needles. Not only is it a safe alternative to
physical restraint, it’s more effective and more predictable than other
methods. It delivers consistent results for your horse each time it’s used.
Use DORMOSEDAN GEL prior to stressful situations and minor,
husbandry (nonpainful) procedures, including:
•Shoeing
•Body clipping
•Bridle path trimming
•Mane pulling
•Sheath cleaning
•First time turnouts for fractious horses
It’s important to withhold food and water until the sedative effect
of the product has worn off. When used prior to first time turnouts,
supervise horse to prevent grazing until the sedative has worn off.
Easy to administer.
Step one
Put on impermeable gloves and
remove the syringe from the outer
carton. While holding the plunger,
turn the ring-stop on the plunger
until the ring is able to slide freely
up and down the plunger.
Step two
Position the ring in such a way that
the side nearest the barrel is at the
desired volume marking. Turn the
ring to secure it in place.
“DORMOSEDAN GEL is useful for husbandry procedures and can be
administered without having a veterinarian present. Its oral gel
formulation is both convenient and safe for horse owners.”
—Rachel Gardner, DVM, Diplomate ACVIM
Step three
Make sure the horse’s mouth
contains no feed. Remove the cap
from the tip of the syringe and save
for cap replacement. Insert the
syringe tip into the horse’s mouth
from the side of the mouth, placing
the syringe tip beneath the tongue at
the level of the corner of the mouth.
Depress the plunger until the ringstop contacts the barrel, depositing
the product under the tongue.
Step four
Take the syringe out of the horse’s
mouth, recap the syringe and
return it to the outer carton for
disposal. Remove and discard
gloves or wash them in large
amounts of running water.
For best results, allow adequate time (a minimum of 40 minutes) between the
administration of DORMOSEDAN GEL and beginning the procedure. In general,
horses show sedative effects lasting approximately 90 to 180 minutes.
Easy to administer.
Step one
Put on impermeable gloves and
remove the syringe from the outer
carton. While holding the plunger,
turn the ring-stop on the plunger
until the ring is able to slide freely
up and down the plunger.
Step two
Position the ring in such a way that
the side nearest the barrel is at the
desired volume marking. Turn the
ring to secure it in place.
“DORMOSEDAN GEL is useful for husbandry procedures and can be
administered without having a veterinarian present. Its oral gel
formulation is both convenient and safe for horse owners.”
—Rachel Gardner, DVM, Diplomate ACVIM
Step three
Make sure the horse’s mouth
contains no feed. Remove the cap
from the tip of the syringe and save
for cap replacement. Insert the
syringe tip into the horse’s mouth
from the side of the mouth, placing
the syringe tip beneath the tongue at
the level of the corner of the mouth.
Depress the plunger until the ringstop contacts the barrel, depositing
the product under the tongue.
Step four
Take the syringe out of the horse’s
mouth, recap the syringe and
return it to the outer carton for
disposal. Remove and discard
gloves or wash them in large
amounts of running water.
For best results, allow adequate time (a minimum of 40 minutes) between the
administration of DORMOSEDAN GEL and beginning the procedure. In general,
horses show sedative effects lasting approximately 90 to 180 minutes.
Información importante sobre la seguridad
DORMOSEDAN GEL® está contraindicado en caballos con hipersensibilidad demostrada a la detomidina. No deben administrarse sulfonamidas potenciadas por vía
intravenosa en caballos anestesiados o sedados ya que pueden producir una arritmia
potencialmente mortal. No use DORMOSEDAN GEL en caballos con bloqueo auriculoventricular (AV) o sinoauricular (SA) preexistente, enfermedad cardiovascular, trastornos respiratorios, enfermedad hepática o renal, o en condiciones de shock, debilidad
grave o estrés provocadas por exceso de calor, frío, fatiga o altitud elevada. Se deben
tomar las precauciones adecuadas al manipular y utilizar jeringas dosificadoras de gel,
pues DORMOSEDAN GEL se puede absorber después de la exposición directa con la piel,
los ojos o la boca y puede causar irritación. Se aconseja utilizar guantes impermeables.
Consulte toda la información sobre prescripción o visite www.DormosedanGel.com.
Important Safety Information
DORMOSEDAN GEL is contraindicated in horses with known hypersensitivity to detomidine. Intravenous potentiated sulfonamides should not be used in anesthetized
or sedated horses, as potentially fatal dysrhythmias may occur. Do not use
DORMOSEDAN GEL in horses with pre-existing atrioventricular (AV) or sinoatrial (SA)
blocks, cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation or stress due to extreme heat, cold, fatigue or high
altitude. Appropriate precautions should be taken while handling and using gel-dosing
syringes, as DORMOSEDAN GEL can be absorbed following direct exposure to skin, eyes
or mouth, and may cause irritation. The use of impermeable gloves is advised. Please
see the full prescribing information, or go to www.DormosedanGel.com.
Guía de referencia para la dosificación
La jeringa dosifica el producto en incrementos de 0.25 ml. La
siguiente tabla proporciona el volumen de dosis que se debe administrar según el peso correspondiente, en incrementos de 0.25 ml.
1.25
440 – 549
1.00
330 – 439
Volumen
por dosis (ml)
peso corporal
aproximado (lb)
1.75
660 –769
1.50
550 – 659
2.50
2.00
990 –1,099
770 – 879
2.25
2.25
2.00
880 – 989
2.50
770 – 879
880 – 989
1.75
990 –1,099
1.50
660 –769
2.75
550 – 659
3.00
1.25
1,100 –1,209
440 – 549
1,210 –1,320
1.00
La duración y el grado de la sedación dependen de la dosis. El
tiempo que tarda el caballo en tranquilizarse por completo es de
aproximadamente 40 minutos y el efecto dura más o menos de 90
a 180 minutos. Si cree que le dio al caballo una dosis mayor de la
necesaria, déjelo recuperar en un sitio tranquilo y tibio y retírele el
alimento y el agua hasta que pase el efecto del tranquilizante.
3.00
330 – 439
Consulte a su veterinario para obtener más instrucciones.
2.75
1,210 –1,320
Dose Volume (mL)
La jeringa está diseñada para usarse una sola vez. Las jeringas parcialmente usadas se deben desechar adecuadamente.
The syringe is designed to be used only once. Partially used syringes
should be properly discarded.
Consult your veterinarian for further instructions.
The duration and level of sedation are dose dependent. The time it
takes before your horse is fully sedate is approximately 40 minutes
and lasts for about 90 to 180 minutes. If you feel you’ve given your
horse a larger dose than necessary, let him recover in a warm, quiet
place and withhold food and water until the sedative has worn off.
1,100 –1,209
Approximate
body weight (lb)
The dosing syringe delivers the product in 0.25 mL increments. The
following dosing table provides the dose volume to be administered
for the corresponding body weight in 0.25 mL increments.
Dosing reference guide

You`re thinking - Paardentandarts Bart Vandepitte

Transcription

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