Silker 50g cream for external use in a tube

The instruction for medical use of Silker Torgovoye medicine a name Silker Mezhdunarodnoye the unlicensed name Silver Sulfadiazinum the Dosage form external use Cream, 50 g Structure of 1 g of cream contains active agent - Sulfadiazinum of silver of 10.00 mg excipients: a macrogoal cetostearyl ether (Tsetomakrogol 1000), cetostearyl alcohol, liquid paraffin (heavy liquid paraffin), butyl hydroxytoluene, dinatrium edetat, methylparahydroxybenzoate, propilparagidroksibenzoat, dihydrophosphate sodium a dihydrate, hydrophosphate dinatrium a dihydrate, the water purified. Description Uniform cream of white or almost white color Pharmacotherapeutic Dermatology group. Antibiotics and chemotherapeutic drugs for treatment of diseases of skin. Chemotherapeutic drugs for topical administration. Sulfonamides. Silver Sulfadiazinum the ATX D06BA01 Code the Pharmacological Pharmacodynamics Sulfadiazinum properties of silver has antimicrobic effect on gram-positive and gram-negative microbes and mushrooms (Candida, Phycomycetes and Aspergillus spp, dermatophytes). The activity of drug is based on silver ions which are released in a wound as a result of moderate dissociation of Sulfadiazinum of silver, than long antimicrobic action which supplements Sulfadiazinum (streptocide) is reached. Ions of silver are adsorbed on a surface of microbic cells and render so-called oligodynamic bacteriostatic and bactericidal action. Drug does not possess nekrolitichesky and mutagen action. Ointment is characterized by moderate osmotic activity. The pharmacokinetics At topical administration can be soaked up to 1% of ions of silver and up to 10% of Sulfadiazinum of the total amount of ointment applied on a wound. The most part of the soaked-up silver is allocated with bile. Sulfadiazinum does not collect in an organism and is quickly emitted through kidneys. Indications - prevention and treatment of the infected burn wounds - the infected skin trophic ulcers and decubituses (as a part of complex therapy) - prevention of infection of the replaced sites of skin and extensive grazes the Route of administration and doses Outwardly. After removal of necrotic fabrics, ointment is applied a thin layer (2‑4 mm) on the damaged surface by 1-2 times a day under a sterile bandage or an open way. Ointment can also be applied on a sterile bandage which is applied to the damaged surface. The maximum single dose – 300 g. Treatment duration – up to 3 weeks. At use of ointment on an extensive surface it is necessary to control function of kidneys and a liver and the maintenance of uniform elements of blood. The patient should give plentiful alkaline drink. Side effects Side effects are classified according to groups of systems and bodies and also frequency of occurrence of MedDRA: very often (≥1/10), it is frequent (≥1/100 to & lt, 1/10), is more rare (≥1/1000 to & lt, 1/100), it is rare (≥1/10,000 to & lt, 1/1000), is very rare (& lt, 1/10,000), it is unknown (it is impossible to determine by the available data). Local reactions from skin and hypodermic fabrics Seldom: allergic reactions (burning sensation, an itching, rashes) It is very rare: local irritative action in the form of short-term burning, pain which undergo System reactions in 5-10 minutes the Concentration of streptocide in blood plasma can reach the same level, as well as in case of system therapy if at a wound a big surface or treatment it is long. In such cases side effects, characteristic of streptocides, can be shown: From blood and lymphatic systems Seldom: a leukopenia, thrombocytopenia, an eosinophilia from mentality It is unknown: alarm from nervous system Seldom: a headache, spasms from digestive tract Often: nausea, vomiting, a diarrhea, a glossitis from a liver and/or a bile-excreting system Seldom: a liver failure from skin and hypodermic fabrics Seldom: an argiriya (as a result of accumulation of silver in fabrics, skin can become pepelnosery). Usually appears at use of ointment on extensive surfaces or at prolonged use. From the skeletal and muscular and accompanying systems It is unknown: a joint pain from kidneys and an urinary system it is rare: a crystalluria, a renal failure inform the doctor On any manifestations of side effects. Contraindications - hypersensitivity to Sulfadiazinum of silver and/or to any excipient of medicine - hypersensitivity to streptocides - genetic deficit glyukozo-6-fosfatdegidrogenazy: at use on extensive surfaces there can be a hemolysis - early children's age (newborns, up to 3 months), premature children in connection with danger of developing of a kernicterus - a porphyria - is inexpedient to apply to treatment of deep purulent wounds and burn wounds with plentiful exudation - pregnancy, the lactation period Medicinal interactions Sulfadiazinum of silver can inactivate fermental drugs for clarification of a wound therefore simultaneous use of these drugs is not recommended. Special instructions With care appoint medicine in a liver and renal failure. If treatment is carried out it is long or apply drug on extensive burn surfaces, then in connection with danger of emergence of a leukopenia, thrombocytopenia or an eosinophilia should define quantity of leukocytes of blood regularly. Also as at topical administration of other drugs in with antimicrobic action, at use of Sulfadiazinum of silver there can be superinfections. Sulfadiazinum of silver cannot apply use in pediatrics premature children and children aged up to 3 months in connection with danger of developing of a kernicterus. Pregnancy and the period of a lactation Data on safety of use of Sulfadiazinum of silver during pregnancy are absent therefore use of ointment during pregnancy and a lactation is contraindicated. Ointment contains in quality of excipients methylparahydroxybenzoate, propilparagidroksibenzoat which can cause allergic reactions (also slowed down type), in some cases – a bronchospasm. Ointment also contains cetostearyl alcohol which can cause local skin reactions (for example, contact dermatitis), and propylene glycol which can cause irritation of skin. The feature of influence of drug on ability to run the vehicle or potentially dangerous mechanisms At this medicine does not have undesirable influence on ability to run vehicles and to serve mechanisms. Overdose Symptoms. At long-term treatment of extensive burn surfaces perhaps systemic action of streptocides: nausea, vomiting, diarrhea, glossitis, joint pains, liver failure, headache, confusion of consciousness, convulsive spasms, crystalluria, renal failure, argiriya, alarm, leukopenia, thrombocytopenia, eosinophilia. Treatment: symptomatic. A form of release and packing On 50 g of cream in the tuba aluminum laminated, sealed by a membrane and the closed screw-on plastic cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer/packer Oxford Laboratories Pvt. Ltd, India B 306, Christal Plaza, New Link Road, Andheri (Vest), Mumbai 400,053 Name and the country of the holder of the registration certificate Oxford Laboratories Pvt. Ltd, India the Name, the address and a contact information (phone, the fax, e-mail) 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 TOO ConsultAsia Shevchenko St. medicine of 165 B ph./fax: +77051708825 e-mail: pv@consultingasia.kz