Ovumiks 6’s vaginal suppositories
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The instruction for medical use of Ovumix Torgovoye medicine a name of Ovumix the International unlicensed name Is not present the Dosage form Suppositories vaginal Structure 1 suppository contains active agents: metronidazole the nitrate micronized 300.00 mg, Miconazolum the sulfate of 48.80 mg, polymyxin micronized 100.00 mg, Neomycinum sulfate of 4.40 mg, a tsentella Asian (Gotha Kola) 15.00 mg, excipient: vitepsol N 15 Description Suppositories from cream till slightly brown color, a cylindrical form, fat, are allowed dark brown impregnations. Pharmacotherapeutic group of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases. Other antiseptic agents and antimicrobial drugs. The ATX G01AX code the Pharmacological Pharmacokinetics Researches properties were not conducted in connection with low system absorption. A pharmacodynamics of Ovumix – the combined drug for topical administration in gynecology. Thanks to active components renders antimicrobial, antiprotozoan, antifungal, regenerative actions. Metronidazole – derivative 5 nitroimidazoles, renders antiprotozoan and antimicrobial effects. 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 of microorganisms, inhibiting its synthesis that leads to death of bacteria. Entamoeba histolytica and also strict anaerobes of Bacteroides spp is active concerning Trichomonas vaginalis. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.). Miconazolum nitrate – derivative an imidazole and triazole has antifungal effect: inhibits synthesis of ergosterol of a cellular membrane. It is active concerning dermatophytes, barmy and some other mushrooms. Shows antimicrobial activity concerning gram-positive microorganisms. Does not change structure of microflora and pH of a vagina. Neomycinum sulfate – an antibiotic of a broad spectrum of activity from group of aminoglycosides. Has bactericidal effect concerning gram-positive (Staphylococcus spp., Streptococcus pneumoniae) and gram-negative (Escherichia coli, Shigella dysenteria spp., Shigella flexneri spp., Shigella boydii spp., Shigella sonnei spp., Proteus spp.) microorganisms. The mechanism of bactericidal action of Neomycinum is connected with influence on ribosomes and oppression of synthesis of protein of a bacterial cell. Maloaktiven concerning Streptococcus spp. Resistance of microorganisms to Neomycinum develops slowly and in small degree. Polymyxin sulfate – the antibiotic produced by spore-forming bacteria of Bacillus polymixa. Has the bactericidal effect connected with disturbance of integrity of a membrane of a microbic cell. It is absorbed on membrane phospholipids, increases its permeability, causes lysis of bacteria. It is active concerning gram-negative microorganisms: Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Escherichia coli, Klebsiella spp., Bordetella pertussis, Haemophilus influenzae, Enterobacter. Fuzobakteriya and bacteroids (Bacteroides fragilis) are moderately sensitive. Does not affect coccal aerobic (Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Neisseria gonorrhoeae, Neisseria meningitidis) and anaerobic microorganisms, the majority of strains of Proteus spp., Mycobacterium tuberculosis, Corynebacterium diphtheriae and mushrooms. Tsentella Asian (Gotha Kola) has wound healing effect: stimulates process of granulation and formation of collagen, promotes epithelization. Indications – vulvita – vaginita – a vulvovaginitis – tservikovaginita – candidiasis – a leukorrhea the Route of administration and doses On 1 suppository a day, before going to bed. Enter deeply into a vagina in a prone position after an evening dress. Duration of treatment is 5-10 days. Side effects Very seldom – burning sensation, local irritation, an itching of a vagina – allergic reactions Despite low system absorption of drug at topical administration, system influence is not excluded, it is necessary to adhere to strictly appointed dosages. At emergence of any undesirable effect it is necessary to stop use of drug and it is necessary to see a doctor. Contraindications – hypersensitivity to any of components of drug or the substances similar in the chemical composition – the first trimester of pregnancy and the period of a lactation – to patients with hematologic diseases – to patients with acute diseases of nervous system – organic diseases of the central nervous system, epilepsy not to use Medicinal interactions when syringing by alkaline solutions. It is not appointed along with oral anticoagulants (warfarin, Dicumarinum) which increase a prothrombin time and bleeding. Consumption of alcohol during treatment can cause vomiting, perspiration, hypotonia (Antabusum – effect). Special indications of Ovumix with care it is appointed to patients with the significant insufficiency of functions of a liver. Patients with a renal failure, diseases of kidneys should use Ovumix with care and only under observation of the doctor. It is not used before sexual intercourse. Use of drug can cause fertilization difficulty. Ovumix it is recommended to appoint after the termination of periods. In case the periods began during treatment, then it is not recommended to be interrupted, it is necessary to use sanitary pads, but not tampons. Use of Ovumix does not prevent development of venereal diseases. The ingredients which are a part of a suppository can damage latex of condoms and a vaginal diaphragm. Pregnancy Use in II and III trimesters of pregnancy only on doctor’s orders when the expected advantage for mother exceeds potential risk for a fruit. Use for children is not recommended to children and teenagers up to 18 years due to the lack of researches about use in this age group. Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms the Overdose When using drug in therapeutic doses does not influence the risk of overdose is absent. Form of release and packing Suppositories vaginal. On 6 suppositories place in blister strip packaging from a film polyvinylchloride. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a box cardboard Storage conditions In the dry place, at a temperature from 15 of 0C up to 30 0C. To store out of children’s reach! A period of storage 3 years Prescription status According to the prescription Laboratorio ELEA S.A.C.I.F Producer. y A., Sanabria 2353, Buenos Aires, Argentina Owner of the registration certificate of Laboratorio ELEA S.A.C.I.F. y A., Sanabria 2353, Buenos Aires, Argentina the Address of the organization accepting claims from consumers on quality of a product in the territory of the Republic of Kazakhstan AVITA (AVITA) LLP, Almaty, Tchaikovsky Street, 15-
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