Sinoart® (Synoart®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSodium hyaluronateSodium hyaluronate
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    FarmSirma Soteks, ZAO     Russia
    • Dosage form: & nbspsolution for intraarticular administration
    Composition:

    1 syringe (2 ml) contains as active substance sodium hyaluronate (in terms of 100% substance) - 0.02 g.

    Excipients: sodium chloride - 0.017 g, sodium hydrophosphate - 0.00044 g, sodium dihydrogen phosphate dihydrate - 0.00009 g, water for injection - up to 2 ml.

    Description:

    Transparent colorless viscous solution.

    Pharmacotherapeutic group:regeneration of tissue stimulant
    ATX: & nbsp

    D.03   Preparations for the treatment of wounds and ulcers

    Pharmacodynamics:

    Pharmacological action is anti-inflammatory, analgesic, corrective metabolism of bone and cartilaginous tissue.

    SINOART® is a sterile, non-pyrogenic, viscous buffered aqueous solution of the sodium hyaluronic acid (sodium hyaluronate) fraction of high purity with a molecular weight ~ 1,7x106 Yes. Hyaluronic acid is a necessary component of the extracellular matrix, is present in high concentrations in composition of articular cartilage and synovial liquid. Endogenous hyaluronic acid provides viscosity and the elasticity of the synovial fluid, and It is also necessary for the formation of proteoglycans in articular cartilage. When osteoarthritis is noted deficiency and qualitative changes in the hyaluronic acid acid in the synovial fluid and cartilage. Intra-articular administration hyaluronic acid on the background degenerative changes in the surface synovial cartilage and pathology synovial fluid leads to improving the functional state the joint. When using the SINOART® preparation, improvement is noted clinical course of osteoarthritis on within six months from the date treatment, there is a counterinflammatory and analgesic effect.
    Pharmacokinetics:

    The sodium salt of hyaluronic acid with intra-articular administration is eliminated from synovial fluid for 2-3 days. Pharmacokinetic studies proved the rapid distribution of the substance in the synovial membrane. Highest concentrations of labeled hyaluronic acid are found in the synovial fluid and articular capsule, smaller concentrations in the synovial membrane, ligaments and adjacent muscles.

    Hyaluronic acid in the synovial fluid is not affected by significant metabolic changes. In the experimental models, the basic metabolism occurs in the periarticular tissues and liver, excretion is mainly carried out kidneys.

    Indications:

    - osteoarthritis and post-traumatic changes of knee and hip joints;

    - pain relief and joint mobility improvement;

    - as an aid in orthopedic surgery.

    Contraindications:

    - hypersensitivity to the active substance or auxiliary components of the drug;

    - severe liver pathology;

    - presence of infection or damage to the skin in the area of ​​injection;

    - children under 18 years of age (due to lack of clinical data).

    Carefully:

    Not described

    Pregnancy and lactation:Do not use during pregnancy and during breastfeeding because of the lack of clinical data.
    Dosing and Administration:

    Intra-articular. In the knee and hip joints, the contents of a single filled syringe (20 mg / 2 ml) should be administered once a week, with a course of 5 injections as described below standard procedure.

    Method of administration

    Before the introduction of Synovial, remove the effusion from the joint bag. Enter the drug should be exactly in the joint cavity by standard methods, taking into account anatomical features.To remove effusion and administer the drug, the same needle can be used, one-shot inserted before aspiration. In this syringe with the drug is attached to the needle, freed from the syringe with aspirated liquid. To confirm the location of the needle in the joint cavity, it is necessary to aspirate the available amount of synovial fluid in the foreground by slow administration of the drug. Follow the rules. asepsis and antiseptics during the procedure. The introduction of the drug into the joint cavity should be stopped when pain occurs during the injection. Avoid getting air into the syringe with the drug.

    Unused until the end of the drug is not subject to storage.

    Side effects:

    There may be a moderate transient, pain, swelling, fever and redness. in the area of ​​injection, an increase in the content of exudate in the joint cavity. The above, the symptoms are transient and usually disappear after 24 hours. If these symptoms occur, it is recommended to relieve the affected joint and apply ice.

    Cases of allergic reactions (pruritus, rashes, urticaria) and anaphylactic reactions to the drug are noted.
    Overdose:There have been no cases of overdose.
    Interaction:

    Synovial should not be administered concomitantly with other intra-articular injections, because of a lack of significant experience.

    Do not use disinfectants containing quaternary ammonium compounds, since hyaluronic acid precipitated in the presence of these substances.

    Special instructions:

    During the first 2 days after the procedure, it is recommended not to overload the joint, especially prolonged loading should be avoided. When receiving the aspiration fluid before the introduction of the drug should be carried out appropriate studies to exclude the bacterial etiology of arthritis.

    Do not use Synovial with damaged or opened packaging.

    Effect on the ability to drive transp. cf. and fur:Synovial does not affect the ability of a person to drive motor vehicles, engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Solution for intraarticular administration 10 mg / ml.

    2 ml in syringes of colorless neutral glass without a needle, with a protective plug and

    with or without a cap an additional cap, or

    additional cap with control first autopsy.

    1 syringe per contour packing from polyvinylchloride film

    or a film of polyethylene terephthalate and films of a multilayer polymer or

    polypropylene films, or films polyethylene, or paper packaging with

    polymer coating, or paper for packaging of medical products,

    aluminum foil or in a bag of paper and films.

    1 contour cell package or package with instructions for use in

    pack of cardboard.

    Packaging:syringe (1) / 1 syringe per circuit pack. 1 circuit cell pack together with instructions for medical use in a pack of cardboard ./- A pack of cardboard
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    1 of the year. Do not use after expiry date..

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000644
    Date of registration:28.09.2011 / 29.09.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.09.2014
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