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Ketazol 2% 15g ointment tube for external use


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The instruction for medical use of KETAZOL medicine the Trade name Ketazol Mezhdunarodnoye the unlicensed name Ketokonazol Lekarstvennaya a form Ointment for external use Structure of 100 g of ointment is contained: active agent: ketokonazol – 2 g, excipients: propylene glycol – 20 g, sodium of a karmelloz – 2 g, a castor-bean tree ordinary seeds oil (castor oil) – 20 g, monoglycerides distilled – 1.4 g, wax emulsion – 3 g, methylparahydroxybenzoate (nipagin) – 0.05 g, butyl hydroxytoluene (Dibunolum) – 0.1 g, the water purified up to 100 g. The description Ointment from color, white to white with a creamy or pinkish shade, with a slight specific smell. Pharmacotherapeutic group Antifungal drugs for treatment of skin. Antifungal drugs for topical administration. Imidazole derivatives. Ketokonazol. The ATX D01AC08 code the Pharmacological Pharmacokinetics At properties external use is practically not soaked up. At prolonged use ketokonazol in blood is not defined. The pharmacodynamics Ketokonazol quickly influences an itching in dermatophyte and barmy infections and also the skin diseases caused by Malassezia spp. Symptomatic improvement is observed before emergence of signs of recovery. Ketokonazol – synthetic derivative an imidazoldioksolana, possessing fungicidal or fungistasis concerning dermatophytes, such as Trichophyton spp., Epidermophyton floccosum and Microsporum spp., and concerning yeast, including Candida spp. and especially concerning Malassezia spp. Indications Treatment of dermatophyte infections of skin, such as dermatomycosis of smooth skin, inguinal epidermophitia, epidermophitia of the feet and brushes caused by Trichophyton spp., Microsporum spp., and Epidermophyton spp. Also Ketazol ointment of 2% is shown for treatment of candidiasis of skin (including a vulvitis), scaly (multi-colored) depriving, the seborrheal dermatitis caused by Malassezia (before Pityrosporum) of spp. A route of administration and doses At an epidermophitia of feet and brushes: Ketazol is recommended to apply ointment of 2% for the struck area 2 times a day. The usual duration of treatment – 1 week. For more crushing and extensive defeats it is necessary to continue treatment, at least, several days after disappearance of symptoms of a disease. In other infections: Ketazol is recommended to apply ointment on the struck area 1 or 2 of time a day, depending on weight of defeat. It is necessary to continue treatment, at least, several days after disappearance of symptoms of a disease. The average duration of treatment is: in a chromophytosis – 2-3 weeks, in a dermatomycosis of smooth skin – 3-4 weeks. If clinical improvement is noted after 4 weeks of treatment, then it is required to specify the diagnosis. Side effect the undesirable effects Provided below are given according to the following gradation of frequency of their emergence: very often (≥ 10%), it is frequent (& lt, 10%, ≥ 1%), infrequently (& lt, 1%, ≥ 0.1%), is rare (& lt, 0.1%, ≥ 0.01%), is very rare (& lt, 0.01%, including separate messages), frequency is unknown (on the available data it is not possible to establish emergence frequency). From the immune system: infrequently – hypersensitivity. From skin and hypodermic fabrics: often – burning, infrequently – bullous rash, contact dermatitis, rash, peeling of skin, stickiness of skin, frequency is unknown – a small tortoiseshell. The general disorders and disturbances in the place of use: often – an erythema and an itching in the site of application, infrequently – bleeding, discomfort, xeroderma, inflammation, irritation, paresthesia, reactions in the injection site. If any of the side effects specified in the instruction are aggravated, or any other side effects which are not specified in the instruction are noted, it is necessary to report about it to the doctor immediately. Contraindications · Hypersensitivity to a ketokonazol or to any of auxiliary components of drug, · Children’s age up to 18 years. Medicinal interactions it was not studied. The special instructions Drug it is intended only for external use. Ointment is not applied in ophthalmologic practice. To prevent a withdrawal after the termination of long-term treatment by local corticosteroids, it is recommended to continue use of local corticosteroids in the morning and Ketazol ointments in the evening, and then gradually, within 2-3 weeks, to cancel therapy by steroids. Children up to 18 years Data on use of a ketokonazol in pediatric group are limited, in the investigation of it drug is contraindicated to children up to 18 years. Pregnancy and the period of a lactation of Data on possible undesirable effects during pregnancy and a lactation are not enough. Therefore during pregnancy and the period of a lactation it is necessary to apply with care. There are no data that at external use ketokonazol can be dangerous at use for pregnant women and during breastfeeding. Plasma concentration of a ketokonazol were not found after use of Ketazol ointment of 2% for skin of non-pregnant women. The risks connected with use of Ketazol ointment of 2% during pregnancy and during breastfeeding are not known. Influence on ability to run the vehicle or potential and dangerous mechanisms Drug does not influence ability to run vehicles and mechanisms. The overdose Causing excessive amount of ointment can cause development of an erythema, hypostasis and burning sensation which usually disappear after the therapy termination. At accidental intake of ointment inside it is necessary to carry out the supporting and symptomatic therapy. A form of release and packing Ointment for external use of 2%. On 15 g in a tuba aluminum. Each tuba together with the instruction for use in a pack from cardboard. Storage conditions In the dry place, at a temperature not above 15 °C. To store out of children’s reach. Period of storage 3 years. Not to apply after an expiration date. Prescription status Without prescription. Name and address of the manufacturing organization Joint-stock company Chemical and pharmaceutical plant AKRIKHIN (JSC AKRIKHIN), Russia 142450, Moscow region, Noginsk district. Old Kupavna, Kirov St., 29. Phone number / fax: +7 (495) 702-95-03. The name and the address of the owner of the registration certificate of JSC Khimpharm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number 7252 (610151) the E-mail address of the Name and the address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of JSC Khimpharm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number +7 7252 (610151) the E-mail address of the Name and the address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of JSC Khimpharm, Republic of Kazakhstan, Shymkent, Rashidov St., 81

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