Gynofortum
Producer: Gedeon Richter (Gideon Richter) Hungary
Code of automatic telephone exchange: G01AF15
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
Active agent: butokonazola nitrate of 20 mg.
Excipients: sorbitol, oil mineral, glyceryl monostearate, polyglyceryl-3-oleate, wax, silicon dioxide colloid, dinatrium эдетат, methylparahydroxybenzoate, пропилпарагидроксибензоат, propylene glycol, water.
Pharmacological properties:
Pharmacodynamics. Butokonazol, derivative an imidazole, has fungicidal activity against mushrooms of Candida, Trichophyton, Microsporum, Epidermophyton. It is most effective at candidiases. Blocking in a cellular membrane formation of ergosterol from a lanosterol, increases permeability of a membrane that leads to a lysis of a cell of a mushroom.
Vaginal cream is an emulsion like "water in oil" therefore gives bioadhesive property to the carrier of a butokonazol (adhesion (Latin of adhaesio — sticking) - coupling of surfaces diverse firm and/or liquids. Adhesion is caused by intermolecular interactions in a blanket. Bioadhesion leads to increase in bioavailability and duration of effect of medicinal substance). At intravaginalny use бутоконазол is on a mucous membrane of a vagina within 4-5 days.
Pharmacokinetics. Cream has high bioadhesive property. At intravaginalny introduction 1,7% of the entered dose are absorbed the Maximum concentration in blood is reached in 13 h and makes 2-18,6 ng/ml. Butokonazol is exposed to intensive metabolism, is partially brought through intestines and kidneys.
Indications to use:
The vagina candidiasis caused by Candida albicans.
Route of administration and doses:
Intravaginalno.
Treatment consists of single use of contents of one applicator (about 5 g) entered into a vagina at any time.
In case of a persistirovaniye of symptoms of a disease it is necessary to repeat a mycologic research.
Instructions on use of the applicator:
- To remove a foil from packaging and to take the applicator. Not to delete the special cap placed on the applicator. Strong holding the applicator with one hand and having pulled another for a ring, to extend from the applicator the piston to a limit.
- The applicator is intended for single use. It is impossible to use the applicator if the cap is removed. It is impossible to heat the applicator before use.
- To carefully enter the applicator as it is possible more deeply in a vagina.
- Slowly pressing on the piston, to squeeze out cream from the applicator.
- To remove the empty applicator from a vagina and to throw out it.
Features of use:
If clinical signs of an infection remain after completion of treatment, it is necessary to conduct a repeated mycologic research for identification of the activator and confirmation of the diagnosis.
Emergence of irritation of a mucous membrane of a vagina or painful feelings serves as the indication to the treatment termination as Ginofort® cream. At accidental hit of the drug Ginofort® in digestive tract it is necessary to make a gastric lavage and to carry out a symptomatic treatment.
To apply with care as the parabens capable to cause allergic reaction are a part of drug.
Influence on ability to driving of the car and to control of mechanisms.
Use of the drug Ginofort® does not influence ability to driving of the car and control of mechanisms.
Side effects:
Burning, itch, morbidity also swelled vagina walls, pains/spasms in the lower part of a stomach.
Interaction with other medicines:
Ginofort® cream contains the mineral oil damaging products from latex or rubber (including condoms or intra vulval diaphragms) therefore within 72 hours after use of Ginoforta® it is not recommended to use the above-stated contraceptives. It is necessary to use other methods of contraception.
Contraindications:
Hypersensitivity to any of drug components. Periods of pregnancy and lactation. Children's age up to 18 years (efficiency and safety are not established).
Overdose:
The drug Ginofort® cream is intended for intravaginalny use. About overdose by drug it was not reported.
Storage conditions:
At a temperature from 15 to 25 °C.
To store in the place, unavailable to children!
Issue conditions:
According to the recipe
Packaging:
Cream of vaginal 2%:
On 5 g of drug in the polypropylene applicator. Each applicator is placed in a polisterolovy case and then packed into the laminated package.
The package together with the instruction on a medical use is placed in a cardboard pack.