The instruction for medical use of ANTIBAKT medicine the Trade name of ANTIBAKT the International unlicensed name Dekvaliniya chloride the Dosage form of the Tablet vaginal, 10 mg Structure One tablet contains active agent – a dekvaliniya chloride of 10.00 mg, excipients: lactose spray dry 250, cellulose microcrystalline PH 102, magnesium stearate. The description of the Tablet of white or almost white color of an oval form, with a biconvex surface. 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). Quinoline derivatives. Dekvaliniya chloride. The ATX G01AC05 code the Pharmacological Pharmacokinetics Later properties of dissolution of the vaginal tablet containing 10 mg a chloride dekvaliniya in about 2.5-5 ml of vaginal liquid, concentration the chloride dekvaliniya in vaginal liquid makes 4000 – 2000 mg/l which is higher, than MPK90 of all studied pathogenic microorganisms. By results of these preclinical trials on rabbits it is possible to draw a conclusion that after vaginal introduction only a small amount a chloride dekvaliniya is soaked up. Thus, systemic action a chloride dekvaliniya slightly and additional data on pharmacokinetics is not available. The pharmacodynamics of Antibakt contains a dekvaliniya chloride, compound of quarternary ammonium with broad antimicrobic activity against the majority of gram-positive and gram-negative bacteria, fungi and prosteyshikhv that number of Trichomonas vaginalis. The mechanism of action Dekvaliniya chloride is surface-active substance. The dekvaliniya of chloride is the main mechanism of action strengthening of permeability of a microbic cell and the subsequent loss of its fermental activity which causes death of a microbic cell. Dekvaliniya chloride shows high bactericidal activity. Dekvaliniya chloride in the form of a vaginal tablet acts locally in a vagina. Noticeable disposal of discharges and inflammation, as a rule, occurs in 24 – 72 hours. The relation a pharmacokinetics / pharmacodynamics Bactericidal effect a dekvaliniya of chloride works within 30 – 60 minutes, reaching the maximum effective local concentration within the first hour after introduction. The mechanism of stability the mechanisms causing own stability of some pathogenic microorganisms are not known. Cases of the acquired stability of pathogenic microorganisms to a dekvaliniya to chloride were not observed. Control points Information on sensitivity of microorganisms lower is descriptive and is based on concentration which can be reached in a vagina and the corresponding minimum overwhelming concentration of pathogenic microorganisms. Antimicrobic range Usually sensitive microorganisms Aerobic gram-positive bacteria: Enterococcus faecalis, Listeria spp., Staphylococcus aureus, Streptococcus agalactiae (group B streptococci), Streptococcus pyogenes (group A streptococci). Aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Klebsiella spp., Pseudomonas spp., Serratia spp. Anaerobic bacteria: Atopobium vaginae, Bacteroides spp., Fusobacteria, Gardnerella vaginalis, Prevotella spp., Peptostreptococci, Poryphyromonas spp Steady microorganisms Gram-negative bacteria: Proteus sp., Chlamydia trachomatis. Other microorganisms: Trichomonas vaginalis Indications – vaginal infections of bacterial origin (bacterial vaginosis) – preoperative prevention of infections at gynecologic interventions and childbirth. The route of administration and doses Is recommended to be applied on one vaginal tablet daily within six days. The vaginal tablet is entered deeply into a vagina in the evening before going to bed. The drug is recommended to be administered in a dorsal decubitus, having slightly bent legs. During periods the treatment should be stopped and continued after its termination. Discharges and inflammation usually pass within from 24 to 72 hours, however it is necessary to continue treatment even if there are no sensations of discomfort any more (the itching, discharges, began to smell). Treatment duration can lead less than 6 days to a recurrence. Side effects In clinical trials it was reported about the following side reactions connected with a dekvaliniya chloride. Often – vaginal discharges, a vulvovaginal itching, vulvovaginal burning – vaginal candidiasis Seldom – a headache – nausea – vaginal bleeding, vaginal pain – a bacterial vaginitis, a fungal skin infection, a vulvitis, a vulvovaginitis Was reported about the following side reactions at post-marketing experience of use: – formation of sores and maceration of a vaginal epithelium, intrauterine bleeding, reddening, dryness of a vagina – cystitis – fever, allergic reactions. Contraindications – hypersensitivity to active agent or any component of a vaginal tablet – ulcer changes of a vaginal epithelium and neck of the uterus – children’s age (the girls who did not reach puberty). Medicinal interactions Anions, such as soap, washing substances and surfactants can reduce antimicrobic activity a chloride dekvaliniya. Thus, simultaneous use of soap, spermitsid or vaginal flourishes (vaginal conditioners) is not recommended. Antibakt, vaginal tablets, does not influence durability of latex condoms. There are no data on an interaction occasion with not latex condoms and other intravaginalny products, such as diaphragms therefore their simultaneous use with Antibakt is not recommended. Special indications of Antibakt contains excipients which can be dissolved not up to the end. The tablet remains sometimes can be found on underwear. It does not affect Antibakt’s efficiency. Sometimes at dryness of a vagina, there is a possibility of incomplete dissolution of a tablet and its loss from a vagina. As a result, treatment in this case is not optimum though mucous it also does not harm. In such cases, before introduction of a tablet to a vagina, it is necessary to humidify it with an insignificant amount of water. For prevention of pollution of linen the patients are recommended to use sanitary pads, to follow rules of personal hygiene, to carry out daily shift of linen and washing it at a temperature not below 80 °C. Patients are recommended to consult with the doctor if at the end of treatment the symptoms remain or in case of a palindromia. Use of higher daily dose or increase in the recommended duration of treatment can increase risk of emergence of vaginal ulcerations. Women have no data on efficiency and safety of treatment of a bacterial vaginosis 18 years are younger and 55 years are more senior. Pregnancy and period of a lactation. Antibakt it can be applied during pregnancy and a lactation. Four clinical trials with participation of 181 pregnant women did not reveal any undesirable influences a chloride dekvaliniya on pregnant women and health of the fruit / newborn. Moreover, considerable post-marketing experience shows lack of toxicity of Antibakt in relation to health of the fruit/newborn. Researches on animals concerning reproductive toxicity were not conducted in connection with the low expected system influence a chloride dekvaliniya. To minimize impact of drug on the newborn, vaginal tablets should not be used within 12 hours before childbirth. System influence of Antibakt on the women nursing is insignificant. Thus, negative impact on the child who is nursed is not expected. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Antibakt does not affect ability to run vehicles and mechanisms. The overdose Overdose by drug is not described. However use of high day doses can lead to formation of sores in a vagina. The form of release and packing On 6 tablets place in blister strip packaging from a transparent film of polyvinylchloride and printing aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer. To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place. To store out of children’s reach! 2 years not to apply a period of storage after an expiration date. Prescription status Without prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Address of the organization responsible for post-registration observation of safety of medicine: Republic of Kazakhstan, Almaty, Shevchenko St. 162 E
to Develop JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
There are no reviews yet.