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Fungoderil 10 mg / ml, 10 ml of solution for external use in vial


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The instruction for medical use of Fungoderil Torgovoye medicine a name Fungoderil Mezhdunarodnoye the unlicensed name Naftifin Lekarstvennaya a form Solution for external use of 10 mg/ml. The structure of 10 ml of medicine contains active agent – a naftifin a hydrochloride – 100.0 mg, excipients – ethanol (in the form of alcohol of 96%), propylene glycol, water purified. The description Transparent, colourless or slightly yellow solution with an ethanol smell. Pharmacotherapeutic group Antifungal means for topical administration. Other antifungal drugs for topical administration. Naftifin. The ATX D01AE22 code the Pharmacological Fungoderil Pharmacokinetics properties, solution is the antifungal allylamine drug intended for external use. Its active ingredient is naftifin. Naftifin is soaked up in skin through a corneal layer (transdermalny way) and well gets into all layers of a nail, is long being present at various layers of skin and at nail plates in anti-mycotic concentration. At clinical use the anti-inflammatory action of a naftifin thanks to which signs of inflammation, especially an itching quickly disappear is noted. Drug does not come to a system blood stream. When drawing on skin only 4% of a dose are absorbed. Therefore system exposure very low. In plasma and urine naftifin it is found in trace quantities. The pharmacodynamics Naftifin possesses fungicide action against the following organisms: Trichophyton spp., Microsporon spp., Epidermophyton floccosum. Naftifin is moderately active against barmy (Candida species), mold (Aspergillus species) and other fungi (e.g. Sporothrix schenkii). He also shows antibacterial activity concerning gram-positive and gram-negative microorganisms which often accompany mycoses. Action mechanism: naftifin, suppressing skvalenepoksidaza enzyme, inhibits synthesis of ergosterol which is necessary for growth of a fungal cell therefore the fungistatic effect is shown. Besides, suppression of a skvalenepoksidaza leads to accumulation of squalene in membranes of a fungal cell and damage of its wall therefore the fungicide effect is shown. Except antifungal action, naftifin has antibacterial activity concerning a number of gram-positive and gram-negative pathogenic microorganisms who often meet in a combination fungal infections: golden staphylococcus, pyocyanic stick, colibacillus, proteas. Indications – the fungal infections of skin and skin folds caused by activators Tinea corporis, Tinea inguinalis – the interdigital mycoses of hands and feet caused by activators Tinea manum, Tinea pedum – fungal infections of nails on hands and legs (onychomycoses), – the skin candidiases caused by Candida – the chromophytosis caused by the Pityriasis versicolor activator. The route of administration and doses Put 2-3 drops of solution by means of an insert dropper on a bottle or by means of a cotton plug. Solution needs to be applied not only on affected areas of a skin/nail, but also on the adjoining sites for prevention of spread of an infection. Fungal infections of skin apply Solution once a day on affected areas of skin which before it have to be cleaned and dried carefully up. Treatment duration: – fungal infections of skin and skin folds – up to 4 weeks, – interdigital mycoses of hands and feet – from 4th to 8 weeks, – skin candidiases – 4 weeks, – a chromophytosis – up to 2 weeks. After manifestation of clinical effect, namely disappearance of an itching and burning, for prevention of returnable infection the treatment should be continued within not less than 2 weeks. Fungal infections of nails on hands and legs (onychomycoses) apply Solution 2 times a day on the struck surface of nail plates which before it have to be cleaned, dried carefully up and as much as possible obstrizhena. Duration of treatment is defined by the speed of growth of nail plates and can be from 3rd to 6 months until the new nail completely grows. Fungoderil is recommended to apply under an air-permeable bandage (plaster, bandage etc.), but it is not necessary to apply under an occlusive bandage. Patients with a renal or liver failure: adjustment of a dose is not required. Elderly patients: adjustment of a dose is not required. Use duration For prevention of a recurrence of an infection treatment is continued by not less than two more weeks after clinical recovery. Patients have to be informed on necessary measures of hygiene for prevention of repeated infection. Side effects the Frequency of emergence of side reactions is specified as: very often (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), infrequently (from ≥1/1000 to & lt, 1/100), is rare (from ≥1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000). The general disorders and disturbances in the injection site the Frequency is unknown: xeroderma, reddening and burning, erythema, itching, local irritation. Side reactions have reversible character and do not demand treatment cancellation. Contraindications – hypersensitivity to a naftifin or excipients – an open wound surface Medicinal interactions are not established Special instructions Fungoderil is intended only for external use. It cannot be applied in ophthalmologic practice and also to apply on open wounds. For elimination of a fungal infection (mycosis), it is recommended to adhere to the following precautionary measures: 1. Fungi can get on the clothes and/or socks coming into contact with the area struck a skin/nail therefore, the clothes and/or socks should be changed every day. 2. Maintenance of the struck surface of a skin/nail in a dry state provides good protection against spread of a fungal infection. It is not recommended to cover an affected area with dense fabric or accessories which limit or interfere with ventilation (for example, the stockings made of synthetic fibers, close footwear). The affected area of a skin/nail should be dried carefully after washing. Also it is necessary to change daily the towels, clothes and/or socks adjoining to the struck surface. 3. In case of a fungus disease of feet, it is not necessary to go barefoot at home or in public places to prevent repeated infection or distribution of pathogenic activators. 4. Saunas or steam baths can be visited only after full disposal of a fungal infection. If within 4 weeks after use of Fungoderil medicine clinical improvements are not observed, it is necessary to see the attending physician. Therapeutic approach has to be reconsidered. Children and teenagers: Safety and efficiency of a naftifin at children and teenagers up to 18 years is not proved (experience of use is insufficient). Pregnancy and a lactation For precaution it is necessary to avoid Fungoderil’s use during pregnancy and during feeding by a breast. The feature of influence of drug on ability to run transport and potentially dangerous mechanisms So far of the message about influence did not arrive. Overdose the Acute overdose and system intoxication at external use of a naftifin are improbable. At accidental intake the corresponding symptomatic treatment is recommended. A form of release and packing On 10.0 ml in the bottles corked by a cover screw with a safety ring and an insert dropper or in the bottles for medicines from cast brown glass corked by a dropper and a cover screw complete with a ring of the first opening. Each bottle together with the instruction for medical use is placed in a pack from cardboard. To Store storage conditions in the place protected from light at a temperature not above 25 °C. To store out of children’s reach. Period of storage of 18 months. Not to use after the expiry date specified on packing. Prescription status Without prescription of the doctor. Producer/packer of LLC Pharmtekhnologiya, Republic of Belarus, 220024 Minsk, Korzhenevsky St., 22. Website: Owner of the registration certificate of LLC Pharmtekhnologiya, Republic of Belarus, 220024 Minsk, Korzhenevsky St., 22. The address of the organization accepting in the territory of the Republic of Kazakhstan a claim (offer) from consumers on quality of products (goods): Pharmaline LLP 050028, Republic of Kazakhstan, Almaty, Shamiyeva St. 11 the Address of the organization responsible in the territory of the Republic of Kazakhstan for post-registration observation of safety of medicine: KazBelMedFarm LLP, 040923, the Republic of Kazakhstan, Almaty region, Karasaysky district, the item Rayymbek, Zhastar St., 22
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