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Mifungar 30g of cream in a tube


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The instruction for use
medicine for experts

the Trade name of drug

the International unlicensed name

Active agent: an oksikonazola of nitrate of 11.47 mg (oksikonazola of 10 mg) in 1 g of cream
Excipients: vaseline of white 15.00 mg, stearylalcohol of 12.00 mg, propylene glycol of 11.50 mg, polysorbate of 60 – 5.00 mg, cetylalcohol of 4.50 mg, the benzoic acid of 0.20 mg, water demineralized 50.653 mg.

Pharmacotherapeutic group
Antifungal means.
ATX [D01AC11] code.

The pharmacokinetics
At external drawing is noted insignificant absorption of an oksikonazol by skin, the most part of the applied active agent collects in a corneal layer of skin. In 5 hours after drawing on cream skin in a dose of 2.5 mg/cm2 the concentration of an oksikonazol in epidermis makes 16, 2 µmol (in a superficial corneal layer – 3.64 µmol, in deeper layers – 1.29 µmol). Less than 1% of the caused quantity, after external putting cream in a dose of 150 mg are soaked up, oksikonazol in blood serum is not defined.
The pharmacodynamics
Active ingredient is oksikonazol – a synthetic derivative of an imidazole, has antifungal and also antimicrobial effect. Biosynthesis of the ergosterol which is a part of a cellular membrane of pathogenic fungi oppresses. It is active concerning dermatophytes, barmy and other fungi of the sort Trichophyton, Epidermophyton, Microsporum, Candida, Pityrosporum, Aspergillus. It is active concerning a number of microorganisms of the sort Streptococcus, Staphylococcus, Corynebacterium.

the Fungus diseases of skin and indumentum caused by activators, sensitive to drug.
A route of administration and doses
For external use.
To apply on the struck place with a thin layer of 1 times a day, one night better.
Duration of a course of treatment: in skin mycoses – 2 weeks, in mycoses of feet – 1 month. For prevention of a recurrence of a disease it is recommended to continue drug treatment within 1-2 weeks after signs of an absolute recovery. Duration of a course of treatment is not recommended more than 6 months by drug.

Side effects
Are possible side reactions in the form of allergic dermatitis, pain, reddening, an itching of skin, skin rash, a crack, maceration of skin, a folliculitis, burning sensation, pricking.
At emergence of signs of hypersensitivity or irritation of integuments use of drug it is necessary to stop and report about it to the doctor.

Hypersensitivity to imidazole derivatives, other components of drug, children’s age (up to 8 years).
Use of drug during pregnancy and feeding by a breast
is not recommended use of the drug MIFUNGAR CREAM during pregnancy and feeding by a breast.

Medicinal interactions
of Data on interaction of the drug MIFUNGAR CREAM with other medicines it is not received. Without consultation of the doctor not to apply with other drugs to topical administration.

Special instructions
At treatment of fungus diseases of the external genitals caused by activators, sensitive to drug, the simultaneous treatment of sexual partners is necessary.
It is necessary to avoid hit of drug in eyes.

Cases of overdose are not described. At accidental administration of drug the appearance of nausea and vomiting is inside possible. It is necessary to wash out a stomach and to see a doctor, if necessary carry out symptomatic treatment.

Release form
Dosage form: cream
Description: white or almost white, uniform cream, almost flavourless.
Cream in tubas on 30 g

the Expiration date
3 years.
Drug cannot be used on expiry date, specified on packing.

Storage conditions
it is necessary to Store drug the place, dry, inaccessible for children, at a temperature of 10-25 °C!

Prescription status
Release without prescription.

Name and address of the manufacturer:
Zentiva of ampere-second., At a kabelovna 130, 102 37 Prague 10, Dolni Mekholupy, the Czech Republic.
In cooperation with SIEGFRIED PHARMA AG, CH-4800 Zofingen, Switzerland.

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