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Lamisil 1% 15 ml spray (external application)


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The instruction for medical use of LAMIZIL medicine the Trade name Lamizil Mezhdunarodnoye unlicensed name Terbinafin the Dosage form Spray of 1% Structure of 1 g of drug contains active agent – a terbinafin of a hydrochloride of 10 mg excipients: the water purified, alcohol of 96%, propylene glycol, a macrogoal cetostearyl ether, nitrogen. The description Transparent liquid from colourless till light yellow color. Pharmacotherapeutic group Other antifungal drugs for topical administration. Terbinafin. The ATX D01AE15 code the Pharmacological Pharmacokinetics At properties external use Lamizil has extremely low system activity as in a system blood stream less than 5% of a terbinafin are soaked up. Terbinafin gets through skin and collects in sebaceous glands, high concentrations are created in hair follicles and hair. A pharmacodynamics the Antifungal drug for topical administration possessing a wide range of antifungal activity. In small concentration Lamizil has fungicide effect concerning dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. Schönleinii, T.tonsurans, Microsporum canis, M. versicolor, M. gypseum, Epidermophyton floccosum), mold (in the main C.albicans) and certain dimorphous mushrooms (Pityrosporum orbiculare). The activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic. Ламизил® in unusual way changes an early stage of the biosynthesis of sterols happening in mushrooms. It leads to deficiency of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Lamizil’s action is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom. Ламизил® does not influence the system of P450 cytochrome at the person and, respectively, metabolism of hormones or other medicines. Indications – prevention and treatment of fungal infections of skin, including mycoses of feet (foot fungus), an inguinal epidermophitia (tinea cruris), fungal infections of smooth skin of a body (tinea corporis) caused by such dermatophytes as Trichophyton (including, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum – multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare (also known as Malassezia furfur). A route of administration and doses For outwardly use. Adult: Lamizil is recommended to apply spray 1 – 2 time a day, depending on indications. Before use of drug it is necessary to clean and dry affected areas carefully. Drug is sprayed (apply) on affected areas in the quantity sufficient for their careful moistening, besides, apply also on adjacent sites of the affected or intact skin. Duration of treatment and frequency rate of use of drug: dermatomycosis of a trunk, shins: 1 time a day, a course 1 week a dermatomycosis of feet: Of 1 times a day, a course 1 week multi-colored deprive: 2 times a day, a course 1 week the dosing Mode Lamizil of spray at elderly people do not differ from the aforesaid. Side effects Often (≥1/100 to & lt, 1/10): – peeling of skin – naggers Infrequently (≥1/1000 to & lt, 1/100): – reactions of hypersensitivity, rash – damages of skin, a scab, skin diseases, pigmentation disturbance, reddening, burning sensation of skin It is rare (≥1/10000 to & lt, 1/1000): – irritation of eyes – xeroderma, contact dermatitis, eczema Very seldom (& lt, 1/10000): – a small tortoiseshell Isolated cases – a Quincke’s edema, an acute anaphylaxis. Contraindications – hypersensitivity or to any of the inactive ingredients which are a part of drug – children’s age up to 18 years – pregnancy and the period of a lactation With care to apply to a terbinafin in a liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, a tumor, a metabolism disease, occlusal diseases of vessels of extremities. Medicinal interactions Any medicinal interactions Lamizil of spray with other drugs are not known. It is usually noted the special instructions Reduction of Expressiveness of Clinical Manifestations 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. In case in a week of treatment signs of improvement are not noted, it is necessary to verify the diagnosis. It is necessary to be careful when drawing Lamizil’s on the damaged sites of skin as alcohol can cause irritation. Ламизил® spray is intended only for external use. It is necessary to avoid hit it 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. If the drug was accidentally administered in airways at inhalation, then, in case of any symptoms and especially at their permanent preservation, it is necessary to consult with the doctor. At development of allergic reactions it is necessary to cancel drug. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect ability to run the vehicle and other mechanisms Overdose Symptoms: About cases of overdose of drug it was not reported. If accidentally Lamizil spray is accepted inside, it is possible to expect development of the same by-effects, as well as at overdose of the tablets Lamizil (a headache, nausea, pains in epigastriums and dizziness). It is also necessary to consider the content in alcohol drug (28.87%). Treatment: activated carbon, if necessary – symptomatic maintenance therapy. The form of release and packing On 15 ml of drug place in the bottles from polyethylene of high density of white color supplied with the dispensing pump consisting of sealant (thermoplastic), the polypropylene body, a tube from copolymer, the polypropylene spray and a cap from polyethylene of high density. On each bottle paste the label self-adhesive. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not higher than 30 wasps. Not to subject to freezing. To store out of children’s reach! 3 years not to use a period of storage after the expiry date specified on packing. Prescription status Without prescription Producer Delpharm Huningue SAS, Huningue, France the Name and the country of the owner of the registration certificate of Novartis Konsyyumer Hels SA, Switzerland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine of GSC KH KAZAKHSTAN LLP Almaty, Manas St., 32A.

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