BROCHURE FLORAGYN OK 10-2004

Floragyn
®
Lavanda
Silver
Intimo
Vaginal Gel
Ovuli
BIBLIOGRAPHY
Chan, R.C.Y., and A. W. Bruce. 1983. The influence of growth media on the
morphology and in vitro adherence characteristics of Gram-negative urinary
pathogens, J. Urol. 129: 411-417.
Floragyn
®
A Gynecological range of
products for vaginal hygiene
and protection
Chan, R.C.Y., Bruce, A.W. and Reid, G.: Adherence of cervical, vaginal and distal
urethral normal microbial flora to human uroepithelial cells and the inhibition of
adherence of gram-negative uropathogens by competitive exclusion. J. Urol., 131:
596, 1984.
Chan, R.C.Y., Reid, G., Irvin, R.T., Bruce, A.W. and Costerton, J W.: Competitive
exclusion of uropathogens from human uroepithelial cells by Lactobacillus whole
cells and cell wall fragments, Infect. Immun., 47: 84, 1985.
Chan, R.C. Y. and Bruce, A. W.: The influence of growth media on the morphology
and in vitro adherence characteristics of gram-negative urinary pathogens. J. Urol.,
129: 411, 1983.
Mardh, P.A. and Westrom, L.: Adherence of bacteria to vaginal epithelial cells.
Infect. Immun., 13: 661, 1976.
Sobel, J.D., Schneider, J., Kaye, D. and Levison, M.E: Adherence of bacteria to
vaginal epithelial cells at various times in the menstrual cycle. Infect. Immun.,
32: 194, 1981.
Wood, J.R, Sweet, R.L., Catena, A., Hadley, W.K, and Robbie, M.: In vitro
adherence of Lactobacillus species to vaginal epithelial cells, Amer. J. Obst.
Gynec., 153: 740, 1985.
Tagg, J.R., Dajani, A.S. and Wannamaker, L.W.: Bacteriocins of gram-positive
bacteria. Bact. Rev., 40: 722, 1976.
Shahani, K.M., Vakil, J.R. and Kilara, A.: Natural antibiotic activity of Lactobacillus
acidophilus and bulgaricus. II. Isolation of Acidophilin from
L. acidophilus. Cultured Dairy Products J., 12: 8, 1977.
Dott. Larry C. Ford del Department of Obstetric and Gynecology, UCLA School of
Medicine, USA, in una lettera datata 1 novembre 1988 scrive che le soluzioni di
argento hanno proprietà battericida e fungicida per la Candida Albicans e la
Candida Globata. Il dott. E.M. Crooks ha dichiarato che l’argento colloidale
elimina organismi patogeni in tre o quattro minuti di contatto.
So.Se.PHARM - EXPORT
Pharmaceutical Industrial Group
A pharmaceutical company
dedicated to partnering.
Your Italian partner within
the European Industry
DPE704/01PA
Conceived and made in Italy by:
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (Rome) - Italy
Phone: (0039) 069160011
Fax: (0039) 0691603462
(please dial the local full number)
www.sosepharm.com
Feminine Care
Formulations gynaecologically approved
The good health of the vaginal mucous membrane largely depends
on preserving the prevalence of non-pathogenic bacterial strains
identified in the various species of lactobacilli, which, thanks to their
actions, prevent the proliferation of other germs.
The bacterial populations found in the human vagina represent a
complex ecosystem, to which a wide range of “host-derived
substances” contribute.
There are numerous factors that may alter the composition of the
vaginal ecosystem (antibiotic treatment, excessively frequent
Floragyn ® Silver
vaginal douches, hormonal disorders, and diabetes).
With colloidal metallic silver
The alteration or reduction of the normal vaginal flora leaves the
Floragyn ® Silver Mousse
mucous membrane susceptible to microbial infections, with
Its mousse forms a thin layer
inside the cervical-vaginal
mucous membrane.
consequent harmful effects.
The micro flora of the vaginal tract has been widely studied,
through the use of advanced microbiological techniques, in order to
understand the composition and characteristics of vaginal secretion.
®
The ”barrier” action at protective effect, carried out by the lysates of
lactobacilli towards the alteration of bacterial flora and of possible
infective consequences, contributes to maintain the pH of mucosa
within physiological values (pH 4-4.5).
In fact the increase of pH of vagina, favours the flourishing and growth
of pathogenic germs and increases the risk of severe infections.
®
The range of Floragyn products, all of them CE certified, was
developed as a result of the above observations and consists of:
Floragyn ® Lavanda, Floragyn ® Intimo,
Floragyn ® G el, Floragyn ® O vuli , Floragyn ® Silver
Ovuli
harmful either directly or through the products of their metabolism.
Floragyn
which can protect the vagina from other bacteria that could be
®
colonised by non-harmful bacterial strains, especially lactobacilli,
Floragyn
Complete and effective treatment with lysates of lactobacilli
and lactic acid to restore vaginal pH to physiological values.
Balancing action of lysates of lactobacilli for local use.
aginal hygiene is one of the
most important aspects of
feminine hygiene.
The topic deserves special
consideration because while, on
the one hand, vaginal washes are
an effective tool for maintaining
intimate hygiene, on the other
hand, frequent washes can also
alter or contribute to the
alteration of an environment
whose state of health depends
on a delicate balance affected by
several factors.
The need for frequent intimate
cleansing often leads to
impoverishment of the natural
vaginal flora, with consequent
exposure to the risk of bacterial
infections.
V
Clinical studies have found that the vaginal mucous membrane is
3 What is Floragyn® Ovuli
Floragyn® Ovuli, medical device product certified by
European competent authorities with CE mark, was developed
as unique and particularly effective formulation for the
maintenance and the restore of normal bacterial flora of
vaginal mucous membrane.
3 Floragyn® Ovuli contains:
Lysates of Lactobacilli present with the following six strains
(Bulgaricus, Acidophilus, Biphidus, Termophilus, Plantarum
and Casei). The above 6 mentioned lysates concur for
obtaining ‘barrier effect’ to the inhibition of pathogenic
bacteria species (also in different subjective symptoms) and to
the adjustment of physiological vaginal mucosa pH, so to
equilibrate and to prevent external pathogenic germs from
colonizing autochthonous physiological bacterial flora. The pH
of the ovule during its preparation is adjusted by Lactic Acid
and Vitamin C so to guarantee, once the ovule is melted inside
the vagina, the spraying of vaginal mucosa at pH range of 4
and 4.5. Lysates of lactobacilli are stabilised in seaweed
extract (laminaria ochroleuca), with soothing and antiirritation properties. Hence, the seaweed extract contributes
effectively to the rapid reduction in itching and is a valid
support in maintaining the physiological status induced by
lysates of lactobacilli. Then the presence of Wheat germ
glycerides, with cicatrising and healing properties, guarantees
cicatrising and healing actions on the deepest layers of
mucous membrane epithelium.
3 Why to use
Floragyn® Ovuli is indicated for treatment and adjustment of
physiological pH of vaginal mucosa, and hence helps to
maintain intact the natural defenses of vagina. It is a complete
and particularly effective treatment able to exploit the
equilibrating action of lysates of lactobacilli for local use.
Useful in case of vaginal dryness, in preventing and eventually
healing irritations, burnings, itchings and vaginitis. The
product controls and maintains the natural balance of vaginal
flora, restores the physiological pH, soothes thanks to the
seaweed extract, and contributes effectively to the rapid
reduction of sensation of itching.
Floragyn® Ovuli does not substitute medical therapy but
represents a useful complementary product.
3 How to use
Introduce the ovule deeply into the vagina, lying down and
preferably at bed-time.
Ovuli
3 When should be not used
There are not known contraindications following the use of
Floragyn® Ovuli, except eventual and rare individual cases of
hypersensitivity to any of the components. Interactions or
incompatibilities are not known.
3 Warnings and precautions for use
To use the product for long-term therapy, as per all topical
products, could originate local sensitivity skin irritations. If
any side effects get worse, or if any side effects not listed in
this leaflet are noticed, discontinue treatment and please
inform your doctor or pharmacist. Floragyn® Ovuli contains
methyl-p-hydroxybenzoate (methylparaben) which might
cause allergic reactions. The tip of the ovule may be yellowbrown in colour. This is due to the presence of lactobacilli and
does not affect the quality of the product.
3 Special precautions during pregnancy and lactation
The use of the product is not discouraged in pregnancy and
lactation. Ask your doctor before using the product for advice.
3 Eventual declared toxicity
No declared toxicity.
3 Maintenance, storage and preparation of the device
No particular precaution is necessary for proper maintenance,
storage and preparation of the device. Store below 25°C. Do
not use the product after the expiry date indicated on the
external pack. Such date refers to the product in integral
packaging, and correctly stored.
Keep out of the reach and sight of children.
3 Special precautions for disposal and other handling
No special precautions for transport. After use, do not throw
away the empty containers or residuals of the product. Use the
containers for waste sorting of products according to the local
legislation.
3 Composition
Glycerides Hemi-Synthetiques/Lecitine; Wheat Germ Glycerides
(Vitabiol); Glycine; Caprylic/Capric Triglyceride Laminaria
Ochroleuca; Mix of Lysates of Lactobacilli (Bulgaricus, Biphidus,
Acidophylus Termophilus, Casei, Plantarum), Methylparaben,
Ascorbic Acid, Lactic Acid, Perfume.
3 Retail format
One cardboard sheet containing one blister of 6 vaginal ovules
x 2/ each one and one inner leaflet.
Vaginal Lavage solution with lysates of lactobacilli developed
to balance physiological vaginal pH. Topical use
Vaginal Gel
Lavanda
dryness signs and symptoms caused by menopause,
menstrual cycle, use of medicines, actual presence of vaginal
inflammatory pathologies and/or use of not suitable vaginal
cleansing product which might depauperate bacterial flora.
Floragyn® Vaginal Gel solves vaginal problem re-establishing
the physiological characteristics of mucosa and by which,
eliminates all unsatisfactions associated to sexual sphere.
Floragyn® Vaginal Gel does not substitute medical therapy
but represents a useful complementary product.
3 How to use
Single use small tube with integrate applicator. Topical use.
3 When should be not used
There are not known contraindications following the use of
Floragyn® Vaginal Gel, except eventual and rare individual
cases of hypersensitivity to any of the components.
Interactions or incompatibilities are not known.
3 Warnings and precautions for use
To use the product for long-term therapy, as per all topical products,
could originate local sensitivity skin irritation. If any side effects get
worse, or if any side effects not listed in this leaflet are noticed,
discontinue treatment and please inform your doctor or pharmacist.
3 Special precautions during pregnancy and lactation
The use of the product is not discouraged in pregnancy and
lactation. Ask your doctor before using the product for advice.
3 Eventual declared toxicity
No declared toxicity.
3 Maintenance, storage and preparation of the device
No particular precaution is necessary for proper maintenance,
storage and preparation of the device. It is important to keep
always the information of the product; hence store both the
external pack and this leaflet. Do not use the product after the
expiry date indicated on the external pack. Such date refers to
the product in integral packaging, and correctly stored.
Keep out of the reach and sight of children.
3 Special precautions for disposal and other handling
No special precautions for transport. After use, do not throw away
the empty containers or residuals of the product. Use the containers
for waste sorting of products according to the local legislation
3 Composition
Depurated Water, Antimousse Silbione, Vegetal Natural Glycerine,
Hydrolyzed Elastin, Mix of Lysates of Lactobacilli (Bulgaricus,
Acidophilus, Biphidus, Termophilus, Plantarum, Casei), Vitamin A
Palmitate, Emulgin HRE 40, Chlorexidine Digluconate, Germaben II,
Corinne 2/399, Pure Sodium Hydroxide 2N.
3 Retail format
One cardboard sheet containing 6 single dose gels x 9 ml/each
one and one inner leaflet.
One cardboard sheet containing 1 single dose gels x 9 ml/each
one and one inner leaflet.
®
3 What is Floragyn® Vaginal Gel
Floragyn® Vaginal Gel, medical device product certified by
European competent authorities with CE mark was developed as
unique and particularly effective gel formulation to induce vaginal
dryness symptoms’ remission and improve woman’s quality of life.
Vaginal dryness is present in any woman’s age with the highest
prevalence in the premenopausal and postmenopausal period and
can be originated by different causes and be occasional or chronic
and vary greatly among individuals. Different causes may induce a
decrease or an interruption in vaginal flora production. The most
frequent is the menopause, but physiological stress, use of oral
contraceptives and other medicines, local medications, vaginal
inflammatory pathologies and/or not suitable vaginal cleansing
products. Vaginal dryness is, still nowadays, an underestimated
phenomenon which is often kept concealed due to psychological
reasons by women themselves to doctors and is often related to the
individual psychological sphere of the woman herself such as stress,
anxiety and is also related to sexual intercourse.
Floragyn® Vaginal Gel contains:
• Lysates of Lactobacilli present with six strains (Bulgaricus,
Acidophilus, Biphidus, Termophilus, Plantarum, Casei). They all
concur actively in creating “barrier effect”, which inhibits the
growth of pathogenic bacteria species and adjusts the
physiological vaginal mucous pH. Thus, lysates of lactobacilli
have a crucial role for the vaginal homeostasis and stops external
pathogenic germs in colonizing healthy vaginal ecosystem.
• Vitamin A carries out a skin protective action.
• Elastin of natural origin has a resilient effect.
• Glycerine and amphoteric cleanser provide, in the right
concentration, the gel with the necessary moisturising and
lubricating properties. All the above ingredients concur to
guarantee effective protective action against external agents
able to develop inflammatory process. Their role is to carry out
moistening action simulant the vaginal physiology.
3 Why to use
Floragyn® Vaginal Gel is a medical device which resolves
definitely the problem of vaginal dryness, keeping the vagina
environment pleasant and scented; thanks to its gel
formulation, Floragyn® Vaginal Gel achieves optimal results
without the typical problems caused by using oily (greasy)
substances. Intravaginal gel for daily treatment; in particular
also during and after the menopause, and during pregnancy.
• Relieves rapidly dryness symptoms.
• Optimal product as lubricating also before sexual
intercourse to allow a perfect harmony within the couple.
• Improves vaginal flora.
• Prevents eventual irritations.
Floragyn® Vaginal Gel is a useful product in case of vaginal
Floragyn
Floragyn
®
Gel
Vaginal gel with lysates of lactobacilli and vitamin A developed to
relieve vaginal dryness signs and symptoms. Moistening action
simulant the vaginal physiology. Not greasy product. Topical use.
3 What is Floragyn® Lavanda
Floragyn® Lavanda medical device product certified by
European competent authorities with CE mark, was developed
as unique and particularly effective lavage formulation.
Floragyn® Lavanda is a ready-to-use solution with lysates of
lactobacilli and chlorexidine (0.2%) suitable for intimate
hygiene purposes. The solution, whilst respecting the delicate
balance of vaginal bacterial flora, allows effective cleansing of
the mucous membrane and leaves immediate feeling of
freshness and cleanliness. Particularly recommended in case
of frequent washes because of delicate and carefully studied
components which do not produce irritations. Floragyn®
Lavanda eliminates undesired secretions and is a suitable
product to be used for intimate hygiene after sexual
intercourse. Floragyn® Lavanda, in addiction, carries out
mechanic action in taking off residuals of organic tissues and
clots of blood, so favouring the reduction of unpleasant
odours which were caused by presence of ammine developed
by several anaerobes bacteria peculiar of vaginal exudate.
3 Floragyn® Lavanda contains:
• Sodium Cocoamphoacetate (Miranol Ultra C32), a suitable
cleanser, made from coconut extract, which washes gently.
• Chlorexidine Digluconate, as antibacterial additive able to
preserve the preparation.
• Lysates of Lactobacilli present with following strains
(Thermophylus, Acidophilus, Biphidus, and Bulgaricus).
The qualitative and quantitative choice of the aforementioned
strains, which are usually present in the healthy vaginal
environment, guarantees effective protective action
preventing the onset of infections that encourages the
development of vaginal inflammations and deterging the
vagina with no alteration of normal physiological barriers.
3 Why to use
Floragyn® Lavanda is indicated for prophylaxis and for its
ability to contribute, in the shortest possible time, to recovery
vaginal microbial flora impoverished by pharmacological
treatment against mycotic vulvae-vaginal induced by Candida
vaginalis, in other words candidiasis (fungi/ yeast infections).
In particular Floragyn® Lavanda is indicated, after menstrual
flux, in order to regenerate and to replenish bacterial flora and
to leave an immediate feeling of freshness. Floragyn®
Lavanda is specifically recommended in case that frequent
intimate washes are considered necessary. Floragyn®
Lavanda eliminates undesired secretions and is suitable for
intimate hygiene after sexual intercourse. Floragyn®
Lavanda does not substitute medical therapy but represents
a useful complementary product.
3 How to use
Use of Lavanda:
shake well the bottle before use, then douche. The cannula
can be inserted in various positions: sitting on the bidet or WC,
Lavanda
or standing in the shower or in the bath tub. The solution
should fluid with regularity, squeezing gently the bottle. Do
not wash your vagina with water at the end of lavage. Eventual
light opalescence of liquid and sedimentation on the bottom
of bottle or in suspension is a natural process which does not
affect the quality of the product, but is signal of relevant
presence of lysates of lactobacilli. The shaking the bottle,
reconstitute its natural lactescence. Topical use only.
3 When should be not used
There are not known contraindications following the use of
Floragyn® Lavanda, except eventual and rare individual
cases of hypersensitivity to any of the components.
Interactions or incompatibilities are not known.
3 Warnings and precautions for use
To use the product for long-term therapy, as per all topical
products, could originate local sensitivity skin irritations. If
any side effects get worse, or if any side effects not listed in
this leaflet are noticed, discontinue treatment and please
inform your doctor or pharmacist. Floragyn® Lavanda should
be not used in case of inner lesions. Floragyn® Lavanda
contains methyl and propyl parahydroxybenzoates
(methylparaben) which might cause allergic reactions.
3 Special precautions during pregnancy and lactation
The use of the product is not discouraged in pregnancy and
lactation.
3 Eventual declared toxicity
No declared toxicity.
3 Maintenance, storage and preparation of the device
No particular precaution is necessary for proper
maintenance, storage and preparation of the device. It is
important to keep always the information of the product;
hence store both the external pack and this leaflet. Do not
use the product after the expiry date indicated on the
external pack. Such date refers to the product in integral
packaging, and correctly stored.
Keep out of the reach and sight of children.
3 Special precautions for disposal and other handling
No special precautions for transport. After use, do not throw away
the empty containers or residuals of the product. Use the containers
for waste sorting of products according to the local legislation.
3 Composizione
Aqua (Water), Sodium Cocoamphoacetate (Miranol Ultra C32),
Chlorexidine Digluconate, Imidazolidinylurea, Methylparaben,
Propylparaben, a-bisabolol, Lactic Acid, Simethicone, Lysates of
Lactobacilli (Bulgaricus, Acidophilus, Biphidus, Termophilus,
Plantarum, Casei), Perfume.
3 Retail format
One cardboard sheet containing 5 x 140 ml disposable single
use plastic bottles (with cannula) and one inner leaflet.
One cardboard sheet containing 1 x 140 ml disposable single
use plastic bottle (with cannula) and one inner leaflet.
Intimate soap indicated for daily intimate hygiene
3 What is Floragyn® Intimo
3 Is particularly recommended
3 What is Floragyn Silver
Floragyn® Intimo is an intimate soap indicated for the
for daily hygiene in case of small losses of blood and
reddening, during the menstrual cycle and after labour.
Floragyn® Intimo contains methyl and propyl
parahydroxybenzoates (methylparaben) which might
cause allergic reactions.
3 Ingredients
Aqua, Cocamidopropylbetaine, Sodium olivoamphoacetate,
Magnesium laureth sulfate, Cocamidopropylaminoxide,
PEG-200 hydrogenated glyceryl palmitate, PEG-7
glyceryl cocoate, bisabolol, Lactococcus lysate, Bifidus
lysate, Lactic acid, lythrum salicaria, PEG-40
hydrogenated castor oil, Propylene glycol,
Methylparaben, Propylparaben, PPG-26 buteth-26,
Parfum, disodium edta, Alfaketoglutaric acid,
Imidazolidinylurea.
3 Retail format
One cardboard sheet containing one inner leaflet and
200 ml bottle with metering liquid dispenser.
Silver
Floragyn
®
Silver
3 When should be not used
There are not known contraindications following the use of
Floragyn® Silver, except eventual and rare individual cases
of hypersensitivity to any of the components. Interactions
or incompatibilities are not known.
3 Warnings and precautions for use
To use the product for long-term therapy, as per all topical
products, could originate local sensitivity skin irritations.
If any side effects get worse, or if any side effects not listed
in this leaflet are noticed, discontinue treatment and
please inform your doctor or pharmacist.
3 Special precautions during pregnancy and lactation
The use of the product is not discouraged in pregnancy and
lactation. Ask your doctor before using the product for advice.
3 Eventual declared toxicity
No declared toxicity.
3 Maintenance, storage and preparation of the device
Container under pressure. Protect from direct sun light and
do not expose to a temperature over 50°C. Do not pierce
and do not burn even after the use. Keep out from any
source of combustion. Do not vaporise on a flame or on an
incandescent substance. Avoid smoking. Do not use the
product after the expiry date indicated on the external pack.
Such date refers to the product in integral packaging, and
correctly stored.
Keep out of the reach and sight of children.
3 Special precautions for disposal and other handling
After use, do not throw away the empty containers or
residuals of the product. Use the containers for waste
sorting of products according to local legislation.
3 Composition
Jaluronic acid (as sodium salt); Extract of grain buds;
Colloidal metallic silver; Tween 80; Sodium phospate
dibasic dihydrate; Potassium phospate monobasic; Natural
vegetal glycerine; p.v.p. k 30; Potassium sorbate;
Imidazolidinyl urea; perfume s.l.m 5846; Geranium
nerolene perfume; Purified water.
3 Propellant
Propane, butane, isobutene (no CFC).
3 Retail format
One (1) bottle of 50 ml + four (4) wrapped cannulae.
One (1) bottle of 30 ml + one (1) wrapped cannula.
Floragyn
Floragyn Silver medical device product certified by
European competent authorities with CE mark, was
developed as unique and particularly effective mousse
formulation. Its mousse forms a thin layer inside the
cervical-vaginal mucous membrane.
3 Floragyn® Silver contains
Jaluronic acid (as sodium salt); Extract of grain buds; Colloidal
metallic silver. Jaluronic acid is a natural substance, which
varies in concentration with the age and stimulates the
fibroblasts giving rise to connective tissue. Exploiting this
peculiarity and by a topical use, jaluronic acid boosts skin
reparation. Jaluronic acid covers with a thin layer the vaginal
mucous membrane, forming a natural barrier and boosting the
cicatrisation process and the disappearance of redness,
irritations, and abrasions on the vaginal mucous membrane.
The presence of jaluronic acid rends the device particularly
indicated as co-adjuvant after cervical-vaginal physical
treatment in diatermocoagulation, laser therapy and
cryotherapy. Extract of grain buds, rich of Vitamin E, is a
natural hydrating and eutrophyc oil, able to develop an
emollient and anti-oxidative action and able to cooperate with
the protective actions supplied by the jaluronic acid. Metallic
silver, in its colloidal form, is known as the most ancient and
reliable microbicide. Odourless, tasteless and very gentle on
humid and sensitive tissues. Its action, as preservative,
guarantees the preparation by microbic contamination.
3 Why to use
Is a topical product developed for treating alterations in the
vaginal mucous membrane (irritations, abrasions, burning)
and alterations due to lack of tissue growth.
3 How to use: 1-2 applications a day.
Take off the small white plastic cap and shake well the bottle.
Introduce the cannula on the proper insert on the bottle and
use the product, holding the cylinder upside-down.
Choose a comfortable position and introduce the cannula
into the genital cavity of vagina for about 5 cm; then press
for 4-5 seconds. It is possible to re-use the cannula only
after rinse with hot water.
®
®
®
Intimo
Vaginal mousse containing jaluronic acid, extract of grain buds
and metallic silver, useful for treating alterations of vaginal
mucous membrane.
daily intimate hygiene of external genitals.
Thanks to the presence of the its active ingredients,
®
Floragyn Intimo performs a triple action:
• Effective and gentle daily cleansing and active pH and
bacterial flora prevention against the onset of
inflammatory conditions of mucosa by the biological
antagonism of lactobacilli.
• Anti microbic and antibacterial action because of
positive effect of lythrum salicaria.
• Active interception, thanks the intercepting action of
ions ammonium (NH4+) deriving from fermentation and
maceration processes caused by urine.
3 Floragyn® Intimo is a delicate soap which carries out
anti-bacterial action and active inflammatory or
irritating conditions prevention.
Intimo