Expiration date: 04/2026

Structure and Composition:

Vaginal Cream. 1 g contains butoconazole nitrate 20 mg

excipients: sorbitol, mineral oil glycerol monostearate, polyglyceryl-3-oleate wax colloidal silica disodium edetate propylene glycol methyl parahydroxybenzoate Propyl parahydroxybenzoate water

polypropylene in the applicator 5 g polystyrene in the box, packed in a laminate bag, 1 applicator in paper cartons 1 package.

Description pharmaceutical form:

Soft homogeneous cream white to off-white, free of foreign particles and without visible separation.

Characteristic:

Imidazole derivative.

Pharmacokinetics:

The cream has a high bioadhesive properties. When administered vaginally absorbed about 1.7% of the administered dose. Cmax in the blood is 2-18,6 ng / ml and is reached after 13 hours. Butokonazol subjected to intensive metabolism, partly excreted in the urine and bile.

Description of the pharmacological actions:

It has fungicidal activity against the fungi Candida, Trichophyton, Microsporum, Epidermophyton and some gram-positive bacteria. Most effective for candidiasis. Blocking in the cell membrane ergosterol formation of lanosterol that increases the permeability of the membrane, resulting in lysis of the cells of the fungus.

Vaginal cream is an emulsion of the "water in oil", therefore it gives bioadhesive carrier butoconazole property. Butoconazole in intravaginal application is on the vaginal mucosa for 4-5 days.

Indications:

vaginal candidiasis caused by Candida albicans.

Contraindications:

• hypersensitivity to any component of the drug
  
• during pregnancy
  
• breast-feeding.
  

Application of pregnancy and breastfeeding:

Perhaps only if the potential benefit far exceeds the harm caused to the fetus or child.

Side effect:

Burning, itching, pain and swelling of the wall of the vagina, pain / cramps in the lower abdomen.

Drug Interactions:

Do not use condoms or intravaginal aperture within 72 hours after application Ginoforta (as cream contains mineral oil products from damaging or latex rubber).

Dosage and administration:

Vaginally.

Treatment consists of a single application of the contents of one applicator (about 5 g) was administered in the vagina at any time.

In case of persistent symptoms should be repeated microbiological examination.

Instructions for use of the applicator:

1. Remove the foil package and remove the applicator. Do not delete the special cap placed on the applicator. Firmly holding the applicator in one hand and pulling the other the ring, the piston is pulled out of the applicator to the limit.

The applicator is for single use. You can not use the applicator when the cap is removed. Never heat the applicator before applying.

2. Carefully applicator introduced as deeply as possible into the vagina.

3. Slowly pushing the piston cream is extruded from the applicator.

4. Remove the empty applicator from the vagina and throw it.

Special instructions:

If clinical signs of infection persist after treatment, there should be repeated microbiological examination for the detection of the pathogen and confirm the diagnosis.

The appearance of the vaginal mucosa irritation or pain is an indication to stop treatment cream.

In case of accidental contact with the drug should be carried out into the gastric lavage.