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Erbinol 1% 20g cream for external use




The instruction for medical use of ERBINOL medicine the Trade name Erbinol Mezhdunarodnoye the unlicensed name Terbinafin Lekarstvennaya a form Cream for external use of 10 mg/g, 20 g Structure of 1 g of cream contains active agent – a terbinafin a hydrochloride of 10 mg, excipients: cetostearyl alcohol, vaseline white, liquid paraffin, polysorbate 80, trolamin, benzyl alcohol, the water purified. The description Uniform cream of flavourless white color Pharmacotherapeutic group Other antifungal drugs for topical administration. Terbinafin. The ATX D01AE15 CODE the Pharmacological Pharmacokinetics At properties external use drug quickly gets through a thermal layer of skin and collects in a lipophilic corneal layer. Terbinafin also gets into secretion of sebaceous glands that leads to creation of high concentrations in hair follicles and nails. Less than 5% of a dose are soaked up therefore absorption of a terbinafin in a system blood stream insignificant. The pharmacodynamics Terbinafin represents allylamine and has a wide range of antifungal action. The mechanism of action is connected with specific oppression of an early stage of biosynthesis of sterols in a cellular membrane of mushrooms. It results in deficiency of ergosterol and to intracellular accumulation of squalene that causes death of cells of a mushroom. Action of a terbinafin is carried out by skvalenepoksidaza inhibition in cellular membranes of mushrooms. This enzyme does not belong to a system P450 cytochrome therefore Erbinol does not influence metabolism of hormones or other medicines. Terbinafin has effect on dermatophytes, yeast-like and mold mushrooms, some dimorphous mushrooms. In low concentration has fungicide activity concerning dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold mushrooms (including Aspergillus, Cladosporium, Scopulariopsis brevicaulis). Action on barmy mushrooms of the sort Candida (in the main Candida albicans) can be fungicidal or fungistatic depending on a species of a mushroom. At topical administration terbinafin it is active also concerning Pityrosporum orbiculare (Malassezia furfur) – scaly (multi-colored) depriving of the activator. Indications – fungal infections of skin: mycoses of feet (tinea pedis), an inguinal epidermophitia (tinea cruris), the fungal infections of smooth skin of a body (tinea corporis) caused by dermatophytes of Trichophyton spp., including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis and Epidermophyton floccosum – – multi-colored deprive the skin infections caused by barmy mushrooms, generally the sorts Candida (for example, C. albicans), the caused Malassezia furfur. A route of administration and doses Only for external use. The adult appoint 1 or 2 times a day depending on indications. Before putting drug it is necessary to peel and dry affected areas. Cream is applied a thin layer to the affected skin and by adjacent sites and slightly rub. In the infections which are followed by an intertrigo (under mammary glands, in interdigital intervals, between buttocks, in inguinal area), sites of application of cream can be covered with a gauze, especially for the night. Average duration of treatment: – dermatomycoses of feet, trunks, of shins – 1 week of 1 times a day, – skin candidiasis – 1-2 weeks 1-2 times a day, – multi-colored deprive – 2 weeks 1-2 times a day. Relief of symptoms is done usually within several days. Irregular treatment or the premature termination of drug treatment can lead to a recurrence. In case in a week after an initiation of treatment signs of improvement are not noted, it is necessary to confirm the diagnosis. Patients of advanced age do not have need for dose adjustment. Side effects Reddening in the site of application, feeling of an itching or burning, however seldom result these phenomena in need to stop treatment. Seldom – allergic reactions which development demands the treatment termination. Contraindications – hypersensitivity to drug components – children’s and teenage age up to 18 years Medicinal interactions Any medicinal interactions for Erbinol are not known. Special instructions With care: the liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, a tumor, a metabolism disease, occlusal diseases of vessels of extremities, Reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination there is a risk of a recurrence of an infection. It is necessary to avoid hit of drug in eyes as it can cause irritation. At accidental hit of drug in eyes, they should be washed immediately with flowing water, and in case of development of the resistant phenomena of irritation it is necessary to consult with the doctor. The cetostearyl alcohol which is a part of drug can result in local side effects (for example, to contact dermatitis). At emergence of reaction of hypersensitivity the treatment should be stopped. Pregnancy and the period of a lactation is not recommended use during pregnancy and a lactation. Because clinical experience of use of Erbinol during pregnancy is limited, it is necessary to appoint use of external forms of drug only according to strict indications. Terbinafin is allocated with breast milk therefore in need of prescribing of drug it is necessary to stop breastfeeding. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect ability to driving of motor transport and also performance of work, connected with the increased concentration of attention. The overdose Overdose is improbable, possible only at accidental intake. Symptoms: headache, nausea, stomach ache and dizziness. Treatment: prescribing of activated carbon and gastric lavage, use of symptomatic maintenance therapy if necessary. The form of release and packing On 20 g of drug place in a tuba aluminum with the plastic screwed cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status Without prescription the Producer K.O. Slavia Pharmaceutical S.R. L. , Boulevard Theodor Palladi No. 44C, sector 3, Bucharest, Romania the Owner of a trademark and the certificate of registration of ROTAFARM LIMITED, GREAT BRITAIN (ROTAPHARM LIMITED, GREAT BRITAIN). Owner of the registration certificate of ROTAFARM LIMITED, GREAT BRITAIN

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