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About 3 ml Sertobek 1’s solution for intraarticular administration in the syringe

$183.20

408b816b809b

Description

Instruction for medical use of a product of medical purpose Name of a product of medical purpose: SERTOBEK PRO solution for intra articulate administration of Sodium hyalrunate of 20 mg/ml and chondroitin sodium sulfate of 30 mg/ml it is sterile! Ingredients: 1 syringe contains Active agents: sodium hyalrunate of 60 mg, chondroitin sodium sulfate of 90 mg. Excipients: sodium chloride, sodium dihydrophosphate monohydrate, dinatrium phosphate dodecahydrate, sodium hydroxide or Acidum hydrochloricum, water for injections. Description: Transparent viscous solution from colourless till brown color. Sertobek Pro represents sterile, depyrogenized, viscous buffered aqueous solution of fraction of sodium salt of hyaluronic acid and chondroitin of sodium sulfate. It is applied in the form of a vyazkoelastichny implant to intra articulate introduction to synovial space at the patients suffering from weak or moderate degree of an osteoarthritis or osteoarthrosis. It can be used for therapy of knee or any other synovial joints. Actually is an analog of synovial fluid of the person. Hyaluronic acid – a necessary component of an extracellular matrix, is present at high concentrations as a part of an articulate cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity of synovial fluid and also it is necessary for forming of proteoglycans in an articulate cartilage. In an osteoarthrosis the deficit and qualitative changes of hyaluronic acid as a part of synovial fluid and a cartilage are noted. Intra articulate administration of hyaluronic acid against the background of degenerative changes of a surface of a synovial cartilage and pathology of synovial fluid leads to improvement of a functional condition of a joint. Chondroitin sulfate consists of disakharidny residues of D-glucuronic acid and a glyukozaminoglyukan. Treats to group of hondroprotektor, is an angenesis stimulator, promotes deduction of water and restoration of shock-absorbing functions in cartilaginous tissues. Possesses anti-inflammatory action, allows to increase mobility of joints and to lower pain. Chondroitin sulfate gets into structures of a matrix of cartilaginous tissues and thus has direct impact on metabolic processes. Promotes synthesis and protection of collagen which is a structural basis of all connective tissue structures. At Sertobek Pro’s use the improvement of a clinical course of an osteoarthrosis throughout long term is noted from the moment of treatment, the anti-inflammatory and analgeziruyushchy effect is observed. Scope: – in the pains and limited mobility caused by degenerative dystrophic and traumatic changes knee, coxofemoral and other synovial joints – in an osteoarthrosis, – for temporary substitution and completion of synovial fluid, – at treatment of the patients who are leading active lifestyle and regularly loading the affected joint – as supportive application at orthopedic surgery. Route of administration and doses: The product of medical purpose Sertobek Pro is applied only to intra articulate introduction. Sertobek Pro’s injections are made only by specialists doctors in aseptic conditions. The ready syringe is removed from a sterile case, the cap is removed then the sterile needle which is fixed by small turn is put on. It is necessary to avoid hit of air in the syringe with solution. Contents of one filled syringe should be entered vnutrisustavno, once a week within three weeks in a row. Perhaps simultaneous treatment of several joints. Administration of solution in a cavity of a joint has to be stopped at appearance of pain during an injection. Solution unused up to the end is not subject to storage. For the same joint the repeated course of treatment can be carried out not earlier than in 6 months. Duration of action of a product of medical purpose averages 9 months (from 6 to 12 months). Special instructions: To apply on doctor’s orders. Within the first two days after holding a procedure it is recommended not to overload a joint, especially it is necessary to avoid long activity. When receiving aspiration liquid before Sertobek Pro’s introduction it is necessary to conduct the corresponding researches for an exception of a bacterial etiology of arthritis. It is not necessary to use a product of medical purpose with the damaged or opened packing. Interaction: Sertobek Pro it is not necessary to appoint along with other intra articulate injections, in view of lack of considerable experience. It is not necessary to apply the disinfectants containing salts of quarternary ammonium as hyaluronic acid is besieged in the presence of these substances. Side effect: At the patients applying Sertobek Pro the emergence of local symptoms (pain, feeling of heat, reddening and puffiness) is possible. The above-stated symptoms have passing character and usually disappear 72 hours later. At emergence of the specified symptoms it is recommended to unload the affected joint and to put ice. Isolated cases allergic (an itching, rash, urticaria) and anaphylactic reactions are celebrated. Contraindications: – hypersensitivity to one of the Sertobeka Pro components, – presence of an infection or damages of an integument in the field of an injection, – infectious diseases of joints, – venous or lymphatic staz on side of the affected joint, – disturbance of a coagulant system of blood. Use at pregnancy and feeding by a breast Sertobek Pro should not be used at pregnancy and in the period of a lactation as there are no clinical data. Use in pediatrics Due to the lack of clinical data Sertobek Pro should not be used in pediatrics. Storage conditions: To store at a temperature not above 25 °C. To store out of children’s reach! Not to freeze. Expiration date: 3 years of date of production. Not to apply after an expiration date. Packaging: Solution for intra articulate introduction in the glass syringe. 1 syringe of 3 ml in blister strip packaging. 1 blister strip packaging together with a needle and a leaf insert in a cardboard box. Sterilely! Producer: S.C. Rompharm Company S.R.L., Otopeni, Eroilor street 1A, Romania (K.O. of Rompharm Company of S.R. L., Otopen, Eroilor St. 1A, Romania) the Owner of a trademark and the registration certificate is the company: DR SERTUS ILACH SANAYI VE TIDZHARET LIMITED of SHIRKETI, TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b

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