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Zalain 300 mg vaginal suppositories are 1’s




The instruction for medical use of ZALAIN® medicine the Trade name of Zalain® the International unlicensed name Sertakonazol Lekarstvennaya a form Suppositories vaginal 300 mg Structure 1 suppository contains active agent – a sertakonazol nitrate of 300 mg, excipients: silicon dioxide colloidal anhydrous, glycerides firm semi-synthetic – vitepsol H 19, suppotsir NAI 50. Description White or almost white, oval form, waxy vaginal suppository. Pharmacotherapeutic group of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases. Antiseptic agents and antimicrobial drugs for treatment of gynecologic diseases (excepting combinations with corticosteroids). Derivative imidazole. Sertakonazol the ATX G01AF19 Code the Pharmacological Pharmacokinetics At properties vaginal use concentration of active agent in blood plasma does not reach a detection threshold. After vaginal use of a sertakonazol with a radioactive label in blood plasma radioactive material was not revealed. The pharmacodynamics Sertakonazol is derivative an imidazole. Is antifungal medicine for topical treatment of gynecologic infections. Possesses a wide range concerning a pathogenic fungi of the sort Candida. spp.), in vitro and also has antibacterial activity concerning gram-positive bacteria (stafilokokk and streptococci). The mechanism of action of a sertakonazol consists in suppression of synthesis of ergosterol, the main component of membranes of fungal cells that leads to disorganization and increase in permeability of a cellular membrane, destruction and extermination of a pathogenic microorganism. Indications – the infections of a mucous membrane of a vagina caused by sort Candida mushrooms (candidosis vulvovaginitis) in case of lack of characteristic clinical signs the positive microbiological conclusion in itself is not the indication to start treatment. A route of administration and doses For intravaginalny use. Drug is appointed once. Before use of drug it is necessary to carry out previously a toilet of external genitals with use of neutral soap. The vaginal suppository is entered deeply into a vagina, in a dorsal decubitus, before going to bed. In case of preservation of clinical symptoms perhaps repeated use of drug in 7 days. In a simultaneous infection of vulvar lips and adjacent sites of skin (candidosis vulvitis) the treatment can be complemented with prescribing of the drug Zalain in the form of cream on area of external genitals and perianal area. If necessary it is necessary to reveal and carry out treatment of other infections associated with a fungal infection. Side effects Seldom – allergic reactions (burning sensation, an itching of a vagina) which take place independently and do not demand drug withdrawal It can be also caused by effects of decomposition of the destroyed activators therefore such reaction can also be sign of successful treatment. Messages about expected side reactions Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information. The contraindication – hypersensitivity to a sertakonazol, derivatives of an imidazole or other components of drug – simultaneous use of latex condom or a diaphragm Medicinal interactions is not recommended simultaneous use of a suppository Zalain and local spermicidal contraceptive drugs as easing of spermicidal effect and also latex condoms as their damage is possible is possible. Special instructions At confirmation of the diagnosis of candidiasis it is recommended to reveal and eliminate the household and hygiene factors contributing to the development and preservation of an infection. It is recommended to apply neutral soap to hygiene of genitals, to use cotton underwear instead of synthetic clothes, to avoid intensive washing of a vagina, etc. At use of drug it is recommended to abstain from sexual contacts. The risk of damage of means of barrier contraception (condom or a vaginal diaphragm) increases at their simultaneous use with drug. When using condom during sexual intercourse, the vaginal suppository is recommended to be applied after sexual intercourse. Treatment of any other pathological microorganisms which can be connected with candidiasis is recommended. For prevention of urogenital reinfection the simultaneous treatment of the sexual partner should be considered in each case on an individual basis. Treatment can be carried out to periods time. Treatment has to be stopped in a case emergence of local intolerance or allergic reaction. Use in pediatrics Is not present the corresponding indications for drug Zalain use suppositories vaginal at children’s age. Pregnancy and a lactation of Sufficient data on use of a sertakonazol during pregnancy and a lactation are not present. Considering a drug route of administration (once) and also lack of systemic action of drug, Zalain’s use at pregnancy and in the period of a lactation perhaps if the expected advantage of therapy for mother exceeds possible risk for a fruit and the child. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. The Overdose the Case of overdose does not influence are not described. A form of release and packing On 1 suppository in blister strip packaging from a film of the combined PVH/PE. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a cardboard pack. Period of storage of 5 years. Not to use after an expiration date. To Store storage conditions at a temperature not above 30 °C to Store out of children’s reach! Prescription status Without prescription of Proizvoditel Trommsdorff GmbH and To, Germany Trommsdorff St. 2-6, D-52477 Alsdorf ph. +492404/553-01, fax: +492404/553-208 e-mail: according to the license of firm Ferrer Internasional A.O., Spain the Owner of the registration certificate of CJSC EGIS Pharmaceutical Plant, Hungary the Address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: Representation in RK CJSC EGIS Pharmaceutical Plant 050060, Almaty, Zharokov St. of 286 G ph. + 7 (727) 247 63 34, + 7 (727) 247 63 33, fax: + 7 (727) 247 61 41,

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