PRODUCT RANGE - Home

Transcription

PRODUCT RANGE - Home
PRODUCT RANGE
Table of contents
page
1
®
page
2
®
page
page
page
3-4
5
6
page
7 – 13
®
page
15 – 18
Leaflet Artuvetrin Therapy
®
page
19 – 22
Contact details ArtuVet Animal Health b.v.
page
23
Introduction
Artuvetrin Product range
Artuvetrin Serum Test
- North-West European panel
- South European panel
®
®
Artuvetrin Skin Test and Artuvetrin Therapy – available allergens
Leaflet Artuvetrin Skin Test
Artuv-Eng 04-2016
Introduction
This brochure contains information about the veterinary products ArtuVet Animal Health BV can
supply,
the different allergens for the diagnosis and treatment of atopic dermatitis and the package insert
leaflets of these products.
Diagnosis and treatment
1
Allergies are common in dogs (between 3% and 15% of dogs suffer from an atopic condition) . Other
conditions that appear similar to atopy must first be excluded, based upon previous history and an
extensive examination. To determine the allergens a dog is allergic to a veterinarian can make use of
a skin test and/or a serum test.
Based on the allergens that cause a positive reaction in the patient a special vaccine (immunotherapy)
can be prepared. Allergen-specific immunotherapy (Artuvetrin® Therapy) is effective (75% of dogs
show a clinical improvement)2,3 and safe4. This causal treatment avoids a long-term symptomatic
treatment (e.g. corticosteroids) with possible side effects.
Artuvetrin® is the only licensed allergen specific treatment available in Europe*.
Therefore under the European veterinary medicines regulations (directives 2004/28/EC),
®
Artuvetrin is the product of choice.
®
Ordering Artuvetrin products
®
To order the Artuvetrin products you can contact ArtuVet by email ([email protected]).
Delivery, under normal circumstances, will be within 8 working days after ordering.
ArtuVet
ArtuVet has many years of experience, with veterinary allergies. ArtuVet is therefore ideally placed to
provide optimum advice and support to the veterinarian, with allergy summaries, customer leaflets and
expert advice.
ArtuVet is situated in Lelystad, The Netherlands. ArtuVet is particularly active in the field of
immunotherapy for allergies. Its core activity is the development, manufacturing and marketing of
immunotherapy products for veterinary use.
All products of ArtuVet are produced following the latest pharmaceutical requirements, and our
modern laboratory is GMP (= Good Manufacturing Practice) approved.
This way we can be sure to serve you and your patients with quality products with the highest
reliability.
References:
1.
Hillier, et al. Vet. Immunol. Path 81 (2001) 147-151
2.
Willemse. Tijdschr. Diergeneesk. Deel 129 (2004) 402-408
3.
Tarpataki et al, Hun. Vet. J. 126 (2004) 545-552
4.
Griffin, et al. Vet. Immunol. Path 81 (2001) 363-383
* Licensed in the Netherlands
1
Artuvetrin® product range
Artuvetrin®
Diagnosis
Artuvetrin®
Serum Test
Artuvetrin®
Skin Test
Treatment
Artuvetrin®
Therapy
®
Artuvetrin Skin Test (intradermal test)
The specially developed Artuvetrin® Skin Test determines which substances the dog is allergic to, with
over 80 allergens available for testing. The Skin Test Set can be configured to suit your needs
includes 2 control solutions. An overview of all the allergens available, which can be ordered as
individual tests, is listed in this brochure (page 7 – 13).
Artuvetrin® Serum Test
A serological allergy test, to determine the allergens causing the allergic reaction, is a good alternative
®
for the intradermal skin test. The Artuvetrin Serum Test is such a good and reliable alternative. This
serological test has been specially developed in cooperation with Greer Laboratories (internationally
recognised allergen specialists) and is characterised by high specificity and sensitivity. The test utilizes
the Fc region on the allergen-specific IgE antibodies. On the basis of this test the allergens that may
be responsible for the pet’s atopic dermatitis can be determined.
In the Artuvetrin® Serum Test, an extensive panel of relevant indoor and outdoor allergens is
examined. The specially constructed European panels (North-West and South European panel)
contain the allergens that are clinically relevant for and characteristic of these regions. The
composition of both panels is listed in this brochure (page 5-6).
®
The Artuvetrin Serum Test outcome will be communicated as a clear and easy to interpret result
together with a treatment advice.
Artuvetrin® Therapy
Once it has been established with the aid of the skin test or serum test which substances are causing
the allergy, it is possible to make the dog less sensitive to these substances, or even insensitive. To
this end, an allergen-specific immunotherapy is produced - Artuvetrin® Therapy – on the basis of the
patient-specific substances that are causing the allergic symptoms. A dog can be treated
simultaneously for a number of different allergens with Artuvetrin Therapy (up to 8 allergens can be
combined in 1 therapy).
More information about Artuvetrin Test and Artuvetrin Therapy, the safe and effective treatment of
atopic dermatitis, can also be found on www.artuvetrin.com.
2
Artuvetrin® Serum Test
3
Artuvetrin® Serum Test
®
With the Artuvetrin Serum Test, an extensive panel of relevant indoor and outdoor allergens is examined. The
specially constructed European panels (North-West and South) contain the allergens that are clinically relevant
for and characteristic of these regions.
Allergen adsorbed to the surface of polystyrene microtiter wells
Serum is added to the test well. If present in the serum sample, specific IgE binds to the allergen
A biotinylated monoclonal cocktail of antibodies with specific anti-Fc epsilon reactivity is added to the
well. This monoclonal cocktail binds to different epitopes on the Fc epsilon portion of the IgE molecule.
Avidin-Alkaline Phosphatase conjugate is added to each well. Each enzyme molecule will bind to a biotin
molecule on the IgE-monoclonal complex, enhancing specificity and sensitivity.
To detect the binding of the enzyme, p-nitrophenyl phosphate (pNPP) substrate is added to each well.
When the enzyme is bound to the well, the pNPP substrate converts from a colourless solution to a
yellow coloured end product. The intensity of the signal is proportional to the amount of allergen specific
IgE present in the test serum
4
North-West European panel
Indoor
Outdoor
Mites and insects
Grass pollen
Latin
Acarus siro
English
Grain mite
Latin
Dactylis glomerata
English
Orchard grass
Ctenophalides spp.
Flea
Festuca pratensis
Fescue, meadow
Dermatophagoïdes farinae
Farinae mite
Lolium perenne
Rye grass, perennial
Dermatophagoïdes
House dust mite
Phleum pratense
Timothy
Poa pratensis
Blue grass, Kentucky
pteronyssinus
Lepidoglyphus destructor
Hay mite
Tyrophagus putrescentiae
Copra mite
Fungi
Pollen from weeds and flowers
Latin
Alternaria alternata
Latin
Artemisia vulgaris
English
Mugwort, common
Aspergillus fumigatus
Chenopodium album
Lambs quarter
Cladosporium herbarum
Parietaria officinalis
Pellitory, wall or erect
Plantago laceolata
Plantain, English
Urtica dioica
Nettle, stinging
Epithelia
Latin
Felis domesticus
Yeast
Tree pollen
English
Cat
Latin
Betula spp.
English
Birch
Corylus spp.
Hazel
Salix viminalis
Willow
Latin
Malassezia
5
South European panel
Indoor
Outdoor
Mites and insects
Grass pollen
Latin
Acarus siro
English
Grain mite
Latin
Dactylis glomerata
English
Orchard grass
Ctenophalides spp.
Flea
Festuca pratensis
Fescue, meadow
Dermatophagoïdes farinae
Farinae mite
Lolium perenne
Rye grass, perennial
Dermatophagoïdes
House dust mite
Phleum pratense
Timothy
Poa pratensis
Blue grass, Kentucky
pteronyssinus
Lepidoglyphus destructor
Hay mite
Tyrophagus putrescentiae
Copra mite
Fungi
Pollen from weeds and flowers
Latin
Alternaria alternata
Latin
Artemisia vulgaris
English
Mugwort, common
Aspergillus fumigatus
Chenopodium album
Lambs quarter
Cladosporium herbarum
Parietaria officinalis
Pellitory, wall or erect
Plantago laceolata
Plantain, English
Epithelia
Latin
Felis domesticus
Yeast
Latin
Malassezia
Tree pollen
English
Cat
Latin
Corylus spp.
English
Hazel
Cupressus sempervirens
Cypress, Italian
Olea europaea
Olive
Platanus occidentalis
Sycamore, eastern
6
Artuvetrin® Skin Test and Artuvetrin® Therapy
available allergens
7
Grass pollen
Latin
English
Agropyron repens
Cough grass
Agrostis gigantea
Redtop
Anthoxanthum odoratum
Vernal grass, sweet
Bromus inermis
Brome smooth
Cynodon dactylon
Bermuda grass
Dactylis glomerata
Orchard grass
Festuca pratensis
Fescue, meadow
Holcus lanatus
Velvet grass
Lolium multiflorum
Rye grass, Italian
Lolium perenne
Rye grass, perennial
Phleum pratense
Timothy
Poa pratensis
Blue grass, Kentucky
Grass pollen mixture:
Bermuda grass, Orchard grass, Sweet vernal
grass, Timothy and Velvet grass
8
Pollen from trees and hedges
Latin
English
Tree pollen mixture I:
Acer negundo*
Maple, ash leaved*
Birch, Alder and Hazel
Aesculus hippocastanum
Buckeye, horse chestnut
Alnus glutinosa*
Alder, black*
Betula pendula*
Birch*
Corylus avellana
Hazel
Cupressus sempervirens
Cypress, Italian
Fagus sylvatica
Beech, European
White poplar, Willow, Ash and Ash-leaved
Fraxinus excelsior*
Ash*
maple
Liguster vulgare
European Privet
Olea europaea
Olive
Pinus sylvestris
Pine, scotch
Platanus occidentalis
Sycamore, eastern
Populus alba
Poplar, white*
Salix viminalis*
Willow*
Tilia cordata
Linden
Ulmus Americana*
Elm, American*
Tree pollen mixture II:
English oak, European beech and American
elm
Tree pollen mixture III*:
* Only available in an Artuvetrin® Therapy, not available in the Artuvetrin® Skin Test
9
Pollen from weeds and flowers
Latin
English
Ambrosia elatior
Ragweed, common
Artemisia vulgaris
Mugwort, common
Chenopodium album
Lambs quarter
Leucanthemum vulgare
Daisy
Weed pollen mixture I:
Parietaria officinalis
Pellitory, wall or erect
Common mugwort and Stinging nettle
Plantago laceolata
Plantain, English
Rumex acetosella
Sorrel, red or sheep
Rumex crispus
Dock, yellow
Solidago virgaurea
Goldenrod
Taraxacum officinale*
Dandelion, common*
Urtica dioica*
Nettle, stinging*
Weed pollen mixture:
Common mugwort, Stinging nettle, Common
dandelion and English plantain
Weed pollen mixture II:
Goldenrod, Lambs quarter, Common
dandelion, Red or sheep sorrel and English
plantain
* Only available in an Artuvetrin® Therapy, not available in the Artuvetrin® Skin Test
Pollen of crops
Latin
English
Avena sativa
Oat, cultivated
Brassica napus
Rape
Secale cereale
Rye, common
Triticum aestivum
Wheat
Zea mays
Corn
10
Mites
Latin
English
Acarus siro
Grain mite
Dermatophagoïdes farinae
Farinae mite
Dermatophagoïdes pteronyssinus
House dust mite
Euroglyphus maynei
Euroglyphus maynei
Lepidoglyphus destructor
Hay mite
Tyrophagus putrescentiae
Copra mite
Insects
Latin
English
Aedes communis
Mosquito
Culex
Culicoides
Ctenophalides spp
Flea
Musca domestica
House fly
Periplanata Americana
Cockroach
Tabanus
11
Epithelia
Latin
English
Anas platyrhynca*
Duck*
Anser anser
Goose
Canis familiaris
Dog
Epithelia mixture II:
Cavia porcellus*
Guinea pig*
Duck, Goose and Chicken
Columba palumpus
Pigeon
Cricetus cricetus
Hamster
Equus caballus
Horse
Felis domesticus
Cat
Melopsittacus undulatus
Parakeet
Mus musculus
Mouse
Oryctolagus cuniculus
Rabbit
Ovis aries
Sheep
Pullus gallinaceus
Chicken
Epithelia mixture I:
Guinea pig, Dog, Cat, Hamster and Rabbit
* Only available in an Artuvetrin® Therapy, not available in the Artuvetrin® Skin Test
12
Fungi
Latin
Alternaria alternata
Aspergillus fumigatus
Fungi mixture I:
Alternaria alternata, Aspergillus fumigatus,
Cladosporium herbarum
Botrytis cinerea
Candida albicans
Aspergillus mix:
Cladosporium herbarum
Aspergillus flavus, Aspergillus fumigatus,
Mucor mucedo
Phoma betae
Aspergillus nidulans and Aspergillus niger
Yeast
Rhizopus nigricans
Latin
Malassezia
13
Leaflets
14
Artuvetrin® Skin Test
1.
NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
Artu Biologicals Europe b.v.
Vijzelweg 11
8243 PM Lelystad (NL)
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Artuvetrin Test
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Active substance(s):
Allergen extracts from pollen, mites and insects, epithelia, yeast and moulds:
See vial label.
Per ml:
Concentration per pollen extract/allergen(mixture)
Concentration per epithelium extract/allergen(mixture)
Except for sheep epithelium
Concentration per yeast-/mould extract/allergen
Concentration per mite-/insect extract/allergeen
Except for aedis, flea, culex, tabanus, culicoides
Except for housefly
1000 NU*/ml
100 µg/ml
10 µg/ml
100 µg/ml
100 NU/ml
1000 NU/ml
10 NU/ml
*NU=Noon Unit, defined as follows: the amount of allergen extract obtained from 1 gram raw
material is by definitioin equivalent to 106 Noon Units.
Vial with negative control solution:
Physiological saline solution
Vial with positive control solution:
Histamine phosphate : 0.1 mg/ml
4.
INDICATION(S)
Diagnosis of atopy.
The veterinary medicinal product is indicated for the diagnosis of atopic hypersensitivity
reactions in dogs. For the correct diagnostic assessment, a proper anamnesis must be done
along with an IgE-specific test like the skin test.
15
5.
CONTRAINDICATIONS
- Skin changes in and around the test area.
- Conditions reducing the dog’s general state of health.
6.
ADVERSE REACTIONS
Slight itching after injection.
In sporadic cases anaphylactic shock can occur after injections with allergens with symptoms
like lethargy, oedema of the head, pruritus, dyspnea, vomiting, diarrhea or fainting. In such
cases intravenous treatment with 1 to 5 milliliter (until effective, inject slowly) of an adrenaline
solution (1:1000) is indicated.
If you notice any serious effects or other effects not mentioned in this package leaflet,
please inform your veterinary surgeon.
7.
TARGET SPECIES
Dog
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One 0.05 ml per allergen extract administered intracutaneously in the lateral thorax wall.
9.
ADVICE ON CORRECT ADMINISTRATION
Instructions for correct administration and conduct of the test
• Carefully shave the dog’s lateral thorax wall, the test must be administered on intact
skin.
• Number the injection sites on the dog’s skin with a marker or pen at intervals of 2.5
cm.
• Fill the syringes with the different allergen and control solutions.
• Administer 0.05 ml of each allergen and control solution intracutaneously (a bubble
will appear after injection) with the number on the holder corresponding to the number
written on the skin.
• Read the skin reaction after 15-20 minutes by labelling the increase in the wheal with
a marker or pen.
Interpretation of the skin test
The response to the negative control is usually zero. The response to the allergen solution
with a wheal diameter greater than half the wheal produced by the positive control solution
(or larger than half of the difference in diameter of the positive and negative controls) is
considered positive.
False-positive reactions can be caused by:
• Solutions being injected too close together.
• Damaged skin caused by the shaving or injection in irritated skin.
• The dog scratching the injection site(s) in the period between the intracutaneous
injection and the reading of the test.
• Sedation with morphine. This substance leads to a release of histamine which
produces the wheal.
16
False-negative reactions can be caused by:
• Subcutaneous injection instead of intracutaneous injection.
• Testing outside the relevant season (if applicable).
• Interaction with certain medicines, see under 4.8 Interactions
• The dog lies on the tested side on a cold surface, which reduces the evident increase
in a wheal.
• The dog is greatly stressed.
10.
WITHDRAWAL PERIOD
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Store in the original package.
Do not use after the expiry date which is stated on the label after EXP:
12.
SPECIAL WARNING(S)
Special precautions to be taken by the person administering the veterinary medicinal product
to animals.
In case of accidental self-injection, consult a doctor immediately and show him/her the leaflet
or the label.
People with a known hypersensitivity to mite/insect allergens or one of the excipients must
avoid contact with the veterinary medicinal product.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been proven during pregnancy or
lactation.
Interaction(s) with other medicinal products and other forms of interaction
The immunological veterinary medicinal product must be administered at different sites.
Corticosteroids, tranquillizers, immunosuppressants and antihistamines can interfere with the
allergy test. Therefore, these veterinary medicinal products must be stopped at least two
weeks (depot preparations 6 weeks) prior to the allergy test.
Available safety and efficacy data show that this immunological veterinary medicinal product
can be administered on the same day but not mixed with other Artuvetrin Test preparations.
There is no information available about the safety and effectiveness of this immunological
veterinary medicinal product with any other veterinary medicinal product, except the abovementioned veterinary medicinal products. Regarding the use of this immunological veterinary
medicinal product before or after any other veterinary medicinal product, a decision should
be made in each individual case.
17
Overdose (symptoms, emergency procedures, antidotes)
No other adverse effects are known with overdose than those listed under section 6.
Incompatibilities
As no research has been done into compatibility, the veterinary medicinal product must not
be mixed with other veterinary medicinal products.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Unused veterinary medicinal product or waste materials should be disposed of in accordance
with the national regulations.
Ask your veterinary doctor about how to dispose of medicines no longer required. These
measures should help to protect the environment.
14.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
1 March 2014
15.
OTHER INFORMATION
Glass 3-ml vial with a rubber stopper and aluminium cap.
POM-V
For any information about this veterinary medicinal product, please contact:
Artu Biologicals Europe b.v.
Vijzelweg 11
NL-8243 PM, Lelystad
18
Artuvetrin® Therapy
1.
NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
Artu Biologicals Europe b.v.
Vijzelweg 11
8243 PM Lelystad (NL)
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Artuvetrin Therapy
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substances:
Allergen extracts from pollen, mites and insects, epithelia, yeast and moulds:
See vial label.
The veterinary medicinal product prescribed by a veterinary doctor is individually prepared
for a dog and contains at most eight (8) allergens or mixtures of allergens.
1 ml contains:
Artuvetrin Therapy
Number of
extracts
(allergens)
Concentration
per pollen
extract/
allergen(mixture)
Concentration
per epithelium
extract/
allergen(mixture)
Except for sheep
epithelium
Concentration
per yeast/mould
extract/ allergen
Concentration
per mite/insect
extract/ allergen
Except for flea,
culex, tabanus,
culicoides
1
Artuvetrin Therapy Forte
2
3
4
5
6
7
8
500
NU/ml
333
NU/ml
250
NU/ml
400
NU/ml
333
NU/ml
286
NU/ml
250
NU/ml
100
µg/ml
50
µg/ml
33
µg/ml
25
µg/ml
40
µg/ml
33
µg/ml
29
µg/ml
25
µg/ml
10
µg/ml
5
µg/ml
4
µg/ml
3
µg/ml
4
µg/ml
3
µg/ml
3
µg/ml
3
µg/ml
100
µg/ml
50
µg/ml
33
µg/ml
25
µg/ml
40
µg/ml
33
µg/ml
29
µg/ml
25
µg/ml
100
NU/ml
50
NU/ml
33
NU/ml
25
NU/ml
40
NU/ml
33
NU/ml
29
NU/ml
25
NU/ml
10
NU/ml
5
NU/ml
3
NU/ml
3
NU/ml
4
NU/ml
3
NU/ml
3
NU/ml
3
NU/ml
1000
NU/ml
* NU=Noon Unit, defined as follows: the amount of allergen extract obtained from 1 gram raw
material is by definitioin equivalent to 106 Noon Units.
19
Adjuvant:
Aluminium hydroxide
Artuvetrin Therapy :
Artuvetrin Therapy forte :
4.
0.3 mg
0.5 mg
INDICATION(S)
Treatment of allergen-specific atopy in dogs.
For the correct diagnostic assessment, a proper anamnesis must be done along with an IgEspecific test.
5.
CONTRAINDICATIONS
Do not use with:
-Disorders affecting the working of the immune system (e.g. immunodeficiencies, malignities
and auto-immune diseases).
-Renal function disorders
-Hypersensitivity to the adjuvant or one of the excipients.
6.
ADVERSE REACTIONS
A slight worsening of pruritus can be noted after the allergen injection.
In sporadic cases anaphylactic shock can occur after injections with allergens with symptoms
like lethargy, oedema of the head, pruritus, dyspnea, vomiting, diarrhoea or fainting. In such
cases intravenous treatment with 1 to 5 milliliter (until effective, inject slowly) of an adrenaline
solution (1:1000) is indicated.
If you notice any serious effects or other effects not mentioned in this package leaflet,
please inform your veterinary surgeon.
7.
TARGET SPECIES
Dog
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The veterinary medicinal product is administered subcutaneously according to the following
dosage schedule.
Adjustment period:
Week number
1
3
5
7
10
13
Day
1
15
29
43
64
85
Dosage (in ml)
0.2
0.4
0.6
0.8
1.0
1.0
Maintenance period:
Week number
17
21
Etc.
Day
113
141
Dosage (in ml)
1.0
1.0
20
The maintenance treatment (1.0 ml) is continued after an interval of at least 4 weeks and
lasts for life in principle.
The effect of the treatment can be judged by the improvement in the clinical picture.
If no improvement is evident by 8 months after the start of the treatment, it can be concluded
that further treatment with the allergens in question will not have any effect.
In periods of high concentrations of an allergen in the air (for example during the flowering
season of grasses) to which the dog is allergic, there may occasionally be brief relapses in
the symptoms. It is recommended to reduce the dose during these periods.
In consultation with the treating veterinary doctor, deviations may be made in the dosing
schedule.
9.
ADVICE ON CORRECT ADMINISTRATION
The veterinary medicinal product prescribed by a veterinary doctor is individually prepared
for a patient. Check that the vial contains the therapy prepared for the patient before drawing
it up into the syringe. The allergens are listed on the vial’s label.
Check the quantity of suspension to be administered, following the dosage schedule.
Shake the vial before use. Then insert the needle of the syringe through the rubber cap and
withdraw the required quantity of suspension. Hold the syringe vertical with the needle
upwards and remove any bubbles by tapping the syringe. Press carefully on the plunger until
the first drop appears.
Pull up a fold of skin and form a depression with your index finger. Place the needle in the
depression and push it slowly through the skin. Let go of the skin. Press down on the plunger
slowly and smoothly until the syringe is empty.
10.
WITHDRAWAL PERIOD
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Store in the original package.
Do not use after the expiry date which is stated on the label after EXP:
12.
SPECIAL WARNING(S)
Special precautions for use in animals
It is recommended to reduce as much as possible or even stop the dose of any current
treatment with corticosteroids or immunosuppressants two weeks before starting the
adjustment period for the veterinary medicinal product.
Special precautions to be taken by the person administering the veterinary medicinal product
to animals.
In case of accidental self-injection, consult a doctor immediately and show him/her the leaflet
or the label.
21
People with a known hypersensitivity to allergens or one of the excipients must avoid contact
with the veterinary medicinal product.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been proven during pregnancy or
lactation.
Interaction(s) with other medicinal products and other forms of interaction
The immunological veterinary medicinal product must be administered at different sites.
Available safety and efficacy data show that this immunological veterinary medicinal product
can be administered on the same day but not mixed with other Artuvetrin Therapy
preparations.
There is no information available about the safety and effectiveness of this immunological
veterinary medicinal product with any other veterinary medicinal product, except the abovementioned veterinary medicinal products. Regarding the use of this immunological veterinary
medicinal product before or after any other veterinary medicinal product, a decision should
be made in each individual case.
Overdose (symptoms, emergency procedures, antidotes)
No other adverse effects are known with overdose than those listed under section 6.
Incompatibilities
As no research has been done into compatibility, the veterinary medicinal product must not
be mixed with other veterinary medicinal products.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Unused veterinary medicinal product or waste materials should be disposed of in accordance
with the national regulations.
Ask your veterinary doctor how to dispose of medicines no longer required. These measures
should help to protect the environment.
14.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
1 March 2014
15.
OTHER INFORMATION
POM-V
For any information about this veterinary medicinal product, please contact:
Artu Biologicals Europe b.v.
Vijzelweg 11
NL-8243 PM, Lelystad
22
Artuvet Animal Health
Mail address
P.O. Box 612
8200 AP Lelystad
The Netherlands
Visiting-address Vijzelweg 11
8243 PM Lelystad
The Netherlands
Phone
+31 36 539 7840 (general)
+31 36 539 7847 (sales dep.)
Fax
E-mail
[email protected]
[email protected] (sales dep.)
Website
+31 36 539 7841 (general)
+31 36 536 6321 (sales dep.)
www.artuvetrin.com
23