Chondrogard - instructions for use, doses, side effects, contraindications

active substance: chondroitin sodium sulfate -100 mg - 200 mg; Excipients: benzyl alcohol -9.0 mg -18.0 mg sodium metabisulphite - 1,0 mg 2.0 mg sodium hydroxide to pH 6.0-7.5 to pH 6.0-7.5 water for injection up to 1.0 ml to 2.0 ml

Description:

Transparent colorless or slightly yellowish tinge solution with the smell of benzyl alcohol.

Pharmacotherapeutic group:Reparation of tissue stimulant.

ATX: & nbsp

M.01.A.X.25 Chondroitin sulfate

Pharmacodynamics:

High-molecular mucopolysaccharide, which affects the metabolic processes in the hyaline cartilage. Reduces degenerative changes in the cartilaginous tissue of the joints, accelerates the processes of its restoration, stimulates the synthesis of proteoglycans.

When treatment with the drug decreases soreness and improves the mobility of the affected joints. In the treatment of degenerative joint changes with the development of secondary synovitis,a positive effect can be observed already in 2-3 weeks after the beginning of the drug administration: pain in the joints decreases, the clinical manifestations of the reactive synovitis disappear, and the volume of movements in the affected joints increases. The therapeutic effect persists for a long time after the end of the course of treatment.

Pharmacokinetics:

After intramuscular injection chondroitin sulfate quickly distributed. Already after -30 minutes after the injection, it is found in the blood in significant concentrations. The maximum concentration (Сmах) of chondroitin sulfate in plasma is reached after 1 hour, then gradually decreases within 2 days.

Chondroitin sulfate accumulates mainly in the cartilaginous tissue of the joints. Synovial membrane is not an obstacle to penetration of the drug into the joint cavity. In the experiments it was shown that 15 minutes after intramuscular injection chondroitin sulfate is found in the synovial fluid, then penetrates into the articular cartilage, where its C max is reached after 48 hours.

Indications:

- Degenerative and dystrophic diseases of the joints and spine:

- osteoarthritis of peripheral joints;

- intervertebral osteochondrosis and osteoarthrosis.

- to accelerate the formation of bone callus in fractures.

Contraindications:

- hypersensitivity to the drug or its components;

- bleeding and a tendency to bleeding;

- thrombophlebitis;

- childhood;

- pregnancy and lactation period (data on the safety of the drug are currently not available).

Dosing and Administration:The drug is administered intramuscularly at 100 mg every other day. With good tolerability, the dose is increased to 200 mg, starting with the fourth injection. The course of treatment - 25-30 injections. If necessary, after 6 months, a repeat course of treatment is possible. For the formation of bone callus, the course of treatment is 3-4 weeks (10-14 injections every other day).

Side effects:Allergic reactions (skin itching, erythema, urticaria, dermatitis), hemorrhages at the injection site.

Overdose:At present, cases of an overdose of chondroitin sulfate have not been reported.

Interaction:It is possible to increase the effect of indirect anticoagulants, antiplatelet agents, fibrinolytic agents, which requires more frequent monitoring of coagulation rates when combined.

Special instructions:

Use in Pediatrics

Data on the efficacy and safety of chondroitin sulfate in children are currently not available.

Form release / dosage:

Solution for intramuscular injection 100 mg / ml.

Packaging:1 ml or 2 ml per ampoule of colorless neutral glass with a color fracture ring or with a colored dot and a notch. One, two or three colored rings and / or a two-dimensional bar code are additionally applied to the ampoules. and / or alphanumeric encoding or without additional color rings, a two-dimensional barcode, alphanumeric encoding.

By 5 ampoules in a contoured cell pack of a polyvinylchloride film and aluminum foil or a multi-layer film, or without foil and film. 1 or 2 contour cell packs of 1 ml or 2 ml; or 5 contour packs of 2 ml each, together with instructions for use in a pack of cardboard. 1 ml or 2 ml in sterile syringes, graduated or without graduation; with a needle, with a protective cap or without a needle, with a protective cap and an additional cap or without an additional cap, or with an additional cap with the control of the first opening. Syringes with a needle can be completed an additional automatic or non-automatic device to protect the needle after using the syringe. 1 or 2 syringes in a contour acrylic package from a film of ion-chloride or polyethylene terephthalate and a film of multilayer or polypropylene or polyethylene or paper with a polymeric coating or paper for packaging medical products or aluminum foil.

5 contour mesh packages together with instructions for use in a pack of

cardboard.

In a pack of syringes without needles, a set of 5 or 10 needles can be added.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005817/09

Date of registration:17.07.2009

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

FarmSirma Soteks, ZAO Russia

Information update date: & nbsp29.09.2015

Illustrated instructions

Instructions

Hondroguard® (Chondrogard)