Rozamet 1% 25g cream for external use

The instruction for medical use of medicine the Trade name of Rozamet® the International unlicensed name Metronidazole Dosage Form Cream for external use of 1%, 25 g Structure of 1 g of cream contains active agent - metronidazole of 10 mg, excipients: the glycerin, liquid paraffin, wax emulsifying, propylene glycol, methylparahydroxybenzoate, propilparagidroksibenzoat, the water purified. Description Uniform cream of white color. Pharmacotherapeutic group Antimicrobial drugs for topical administration. Antimicrobial drugs other. Metronidazole. ATX D06BX01 code the Pharmacological Pharmacokinetics Absorption properties minimum, after external use in blood serum are found only trace amounts of drug. The soaked-up metronidazole passes through a placenta and a blood-brain barrier, gets into breast milk. The pharmacodynamics Metronidazole is derivative a nitroimidazole, possesses antibacterial, antiprotozoan action. The mechanism of action consists in biochemical restoration 5 nitrogroups of metronidazole intracellular transport proteins of anaerobic microorganisms and protozoa. The restored 5 nitrogroup of metronidazole interacts with DNA cells of microorganisms, inhibiting synthesis of their nucleic acids that leads to death of bacteria. Entamoeba hystolytica and also gram-negative anaerobe bacterias of Bacteroides spp, Fusobacterium spp is active concerning Trichomonas vaginalis. and some gram-positive anaerobe bacterias (sensitive strains of Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.) At external use has antiacne effect which mechanism is precisely unknown. Metronidazole of external use, perhaps, has antioxidant activity. Indications - for treatment of inflammatory defeats and an erythema at a rozatse the Route of administration and doses Outwardly. Розамет® cream is applied on previously cleaned affected areas of skin with a thin layer of 1 times a day. After use of Rozamet® of cream it is allowed to use cosmetics. Children Drug is not used at children and teenagers up to 18 years due to the lack of data on safety and efficiency. Side effects - skin reactions in the site of application, aggravation of symptoms, paresthesia, acne rash, xeroderma. The following spontaneous side effects are also possible: pricking or numbness of extremities, allergic reactions, irritation of skin and eyes, rash, a headache, nausea and zaporoshok Contraindications - hypersensitivity to the basic and auxiliary components of drug Medicinal interactions At topical administration of Rozamet® of cream for external use interaction with other medicines is insignificant. It is necessary to be careful at co-administration with coumarin and warfarin (increase a prothrombin time). Special instructions Only for external use! In case of skin inflammation, use of drug should be stopped temporarily. To avoid hit in eyes! According to messages, dosage forms of metronidazole for topical administration can cause conjunctivitis. Metronidazole belongs to group of derivatives of a nitroimidazole, patients with signs have blood dyscrasias, including in the anamnesis, drug should be used with care. Pregnancy and the period of a lactation Clinical experience of external use of metronidazole at pregnant women is absent. Metronidazole gets through a placental barrier and quickly comes to a fruit blood stream. After oral introduction to rats or mice of metronidazole in doses, in 200 and by 20 times respectively exceeding clinical doses, manifestations of a fetotoksichnost were not observed. Nevertheless, as researches of reproductive toxicity at animals not always allow to predict response at the person, and at oral introduction metronidazole showed to rodents cancerogenic properties, Rozamet® cream should be applied during pregnancy only in the presence of accurate indications, after consultation with the doctor. After intake, metronidazole gets into breast milk in concentration, similar subjects which were found in blood plasma. In spite of the fact that after external use of the drug Rozamet® cream its level in blood is much lower, than after intake of metronidazole inside, the decision on the termination of breastfeeding or phase-out of drug has to be accepted taking into account assessment of importance of use of drug for mother and risk for the newborn. Use in pediatrics the Data on safety and efficiency of use of Rozamet® cream at children and teenagers up to 18 years are absent. Features of influence on ability to run motor transport or other mechanisms the Overdose does not influence the Form of release and packing On 25 g of drug in the aluminum tuba covered with twice protective varnish with the soldered opening and a plastic cap is not revealed. The tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C to Store out of children's reach! 2 years not to apply a period of storage after an expiration date. Prescription status Without prescription YaDRAN-GALENSKI Producer of LABORATORIES and. lake, Svilno 20, 51000 Rijeka, Croatia Name and country of the owner of the registration certificate of YaDRAN-GALENSKI of LABORATORIES and. lake, Croatia Name and country of the YaDRAN-GALENSKI organization packer of LABORATORIES and. the lake, Croatia the Name, the address and a contact information 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 of YaDRAN-GALENSKI of LABORATORIES and. lake Kazakhstan, 050059, Almaty, Zhamakayev St., 126 of ph. (fax): + 7 (727) 271 80 44 e-mail: Regulatory-KZ@jgl.ru