The instruction for medical use of DRASTOP medicine the Trade name Drastop Mezhdunarodnoye the unlicensed name of Chondroitin sulfate the Dosage form Solution for injections of 100 mg/ml, 2 ml Structure 1 ampoule contains active agent: sodium sulfate chondroitin – 200 mg, excipients: benzyl alcohol, sodium of hydroxide of 1% solution or acids of chlorohydrogen 0.1 M solution, water for injections. Description Transparent slightly yellowish solution. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs others. ATH M01AX25 code Pharmacological action Pharmacokinetics Chondroitin sodium sulfate is quickly soaked up after intramuscular introduction. In 30 min. after an injection it is found in blood in considerable concentration. The maximum concentration (Cmax) of chondroitin of sulfate in plasma is reached in 1 h, then gradually decreases within 2 days. Chondroitin sodium sulfate collects, mainly, in cartilaginous tissue of joints. The synovial membrane is not an obstacle for penetration of drug into a joint cavity. After an intramuscular injection, in 15 min. chondroitin sodium sulfate is found in synovial fluid, then gets into a joint cartilage where its Cmax is reached in 48 h. A pharmacodynamics the Drug influencing exchange processes in a hyaline cartilage. Reduces degenerative changes in cartilaginous tissue of joints, stimulates biosynthesis of glucosaminoglycans. Chondroitin is high-molecular mucopolysaccharide which is in significant amounts in different types of connective tissue, in particular cartilaginous (serves as additional substrate for formation of a cartilaginous matrix). Influences phosphorus-calcium exchange in cartilaginous tissue, slows down a resorption of a bone tissue and reduces calcium loss, accelerates processes of recovery of a bone tissue. Slows down process of a degeneration of cartilaginous tissue, stimulates processes of regeneration of an articulate cartilage, promotes restoration of an articulate bag, the cartilaginous surfaces of joints. Maintains viscosity of synovial fluid, interferes with compression of connective tissue and plays a role of a peculiar lubricant of articulate surfaces, slows down progressing of an osteoarthritis, facilitates its symptoms, reduces the need for NPVS. Normalizes a metabolism in hyaline fabric, stimulates formation of a gialuron, synthesis of proteoglycans and II collagen, protects gialuron from zymolysis, including lizosomalny enzymes which leads to destruction of connective tissue. The therapeutic effect remains a long time after the termination of a course of treatment. Indications Degenerative dystrophic diseases of joints and backbone: – an osteoarthrosis of peripheral joints – an intervertebral osteoarthrosis and osteochondrosis the Route of administration and doses appoint Drug intramusculary on 1 ml (100 mg of chondroitin of sodium sulfate) every other day. At good tolerance the dose is increased to 2 ml (200 mg of chondroitin of sodium sulfate), since the fourth injection. The course of treatment makes 25-30 injections. If necessary in 6 months carrying out a repeated course of treatment is possible. Side effect – allergic reactions (skin itching, an erythema, a small tortoiseshell, dermatitis, makulopapulezny rash, hypostasis) – hemorrhages in the place of an injection – nausea, vomiting – seldom or never a Quincke’s disease of the Contraindication – hypersensitivity to drug or to its components – bleedings and tendency to bleeding – thrombophlebitises – pregnancy and the period of a lactation – children’s age up to 18 years Medicinal interactions At the combined use with non-steroidal anti-inflammatory drugs Drastop allows to lower a dose of non-steroidal anti-inflammatory drugs. Drug strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik that demands more frequent control of indicators of fibrillation at combined use. The special instructions Use in pediatrics Data on efficiency and safety of use of chondroitin of sulfate for children are absent now. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Overdose does not influence Now about cases of overdose of chondroitin of sulfate it was not reported. The form of release and packing On 2 ml place in ampoules from colourless glass with a ring for a break. On 5 ampoules place in blister strip packaging. On 1 or 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! Period of storage 3 years. Not to use after an expiration date! Prescription status According to the prescription Producer A.Sh. Mefar Ilach Sanayii, Turkey Ramazanoglu Makh. Ensar Dzhad. No. 20, 34906 Kurtkyoy-Pendik / Istanbul, Turkey the Name and the country of the owner of the registration certificate of UORLD MEDITSIN LTD, TBILISI/GEORGIA the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Republic of Kazakhstan, Almaty, Turksibsky district, Suyunbaya Ave., 222 Ph. / fax: 8 (7272) 529090, www.worldmedicine.kz the Address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222 Cellular ph. +7 701 786 33 98 (24-hour access). e-mail: firstname.lastname@example.org
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