Vagilac

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VAGILAC (VAGILAC)

Composition:

Active substance: 1 capsule contains 4 billion colony-forming units (CFU) of Lactobacillus acidophilus, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus;

Excipients: lactose monohydrate; magnesium stearate; ascorbic acid;

Capsule shell: gelatin.

Pharmaceutical form. Vaginal capsules.

Main physicochemical properties: cream-colored gelatin capsules containing white or ivory-colored powder; the presence of individual darker granules is acceptable.

Pharmacotherapeutic group. Other agents used in gynecology.

ATC code G02C X.

Pharmacological properties.

Pharmacodynamics.

Lactobacteria, which predominate in the composition of normal vaginal flora, serve as a natural barrier against infections. These microorganisms contribute to the regulation of vaginal microbial balance through competitive binding to vaginal epithelial cells and production of antimicrobial compounds. The family Lactobacillaceae includes gram-positive, mostly non-motile microorganisms, facultative anaerobes that do not form spores, capable of fermentation, fermenting carbohydrates with the formation of lactic acid, which inhibits the growth of pathogenic and conditionally pathogenic microflora. This is a morphologically heterogeneous group of bacteria, including long and short rods, as well as cocci.

Lactic acid streptococcus creates favorable conditions for the development of lactic acid bacilli by reducing the redox potential to a level conducive to their growth. In turn, lactic acid bacilli produce a water-soluble, thermostable compound that promotes the growth of streptococci, which they themselves cannot produce. The symbiotic relationships existing between lactic acid bacilli and cocci are an essential prerequisite for including these microorganisms in the composition of Vagilak, a preparation used for the prevention and treatment of vaginal dysbiosis of various origins. Lactobacilli assimilate glycogen present in the squamous epithelial cells of the vagina and, through anaerobic glycolysis, release lactic acid, which creates a slightly acidic environment (pH 4.3–4.7) in the vaginal contents. Thus, lactic acid bacteria play an important role in maintaining and restoring the microbial balance of the vaginal mucosa, prevent the development of pathogenic and conditionally pathogenic microflora, and promote self-cleaning of the vagina from conditionally pathogenic flora.

Pharmacokinetics.

The drug is not absorbed from the vagina and therefore does not exert systemic effects on the body. The colonization capacity of lactobacilli contained in Vagilak is enhanced due to the combination with Streptococcus thermophilus.

Clinical characteristics.

Indications.

Prevention and treatment as part of complex therapy of vaginosis of various origins (trichomonal, bacterial, fungal).

Contraindications.

Hypersensitivity to the drug or its components in medical history. Widespread acute inflammatory (purulent) and erosive changes of the vaginal mucosa.

Interaction with other medicinal products and other types of interactions.

The drug can be prescribed as part of combination therapy together with antibiotics, sulfonamides, metronidazole, and other antibacterial agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Vagilac can be used in women during pregnancy and breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

Vagilac does not affect reaction speed when driving vehicles or operating machinery.

Method of Administration and Dosage

The product is intended for vaginal use.

Therapeutic use.

For the treatment of acute, chronic, and recurrent infectious-inflammatory diseases of the female genital organs, Vagilak is administered several days after the start of antibacterial therapy (on day 4–5), and, if necessary, after its completion. Duration of use is 10 days. One capsule at bedtime. Lie down and insert the capsule deeply into the vagina.

Prophylactic use.

For the prevention of diseases of the female genital organs (bacterial vaginosis, candidiasis, trichomoniasis), Vagilak is used starting from the beginning of the second half of the menstrual cycle, for 5 or 10 consecutive days. Lie down and insert the capsule deeply into the vagina. One capsule at bedtime.

Children.

The product is not intended for use in children.

Overdose.

Not possible.

Side effects.

Hypersensitivity reactions are possible; injection site reactions, including erythema and burning sensation.

Shelf life.

3 years.

Storage conditions.

Keep out of reach of children at a temperature from 2 to 8 ºC.

Packaging.

10 capsules per bottle.

Supply category.

Over-the-counter.

Manufacturer.

Pharmascience Inc.

Manufacturer's address and location of business activity.

6111 Royalmount Avenue, Suite 100, Montreal, Quebec H4P 2T4, Canada.