Arthrum visc 75 - prefilled intrarticular syringe 3 ml

Product Description

Resorbable medical device for filling and reconstruction.

Indications

ARTHRUM VISC 75 is a sterile, pyrogen-free, physiological viscoelastic solution based on non-cross-linked hyaluronic acid of non-animal origin. The solution is presented in a single-use pre-filled syringe. Each pack contains one syringe of ARTHRUM VISC 75, an information leaflet, and a set of labels to ensure traceability.

Composition

Each syringe of ARTHRUM 75 MONO INJECTION contains: Sodium hyaluronate (F.B.), Sodium chloride, Borate buffer pH 7.2 ± 0.2, Water for injection qsp.

Directions for use and Dosage

ARTHRUM VISC 75 is intended for intra-articular injection by a qualified specialist in accordance with local laws.

Technical skill is essential for successful treatment; this medical device must be used by physicians with specific training in injection techniques.

The medical device must be used in its original packaging as supplied. Any modification or use of the product that does not comply with the conditions of use reported in this leaflet could compromise its sterility, efficacy and tolerance.

The doctor must inform the patient of the indications, contraindications, incompatibilities and potential side effects of the medical device before starting treatment.

How to use:

1. Before the injection, carefully disinfect the area to be treated;
2. Check that the sterile protection is intact;
3. Take the syringe and remove the protective cap;
4. Holding the body of the syringe, insert the needle into the Luer Lock connection;
5. Carefully rotate the needle clockwise to secure it in the connection;
6. Visually check that the needle is properly secured;
7. Remove the needle cap;
8. Inject slowly.

Failure to follow these instructions may result in needle disengagement and/or leakage of the medical device at the Luer Lock connection. The ARTHRUM VISC 75 dosage regimen is for intra-articular injection.

Warnings

ARTHRUM VISC 75 is indicated for intra-articular injections only.

Do not administer intravascularly. Do not inject outside the joint cavity or into the joint. in the synovial tissue or capsule.

Hyaluronic acid solution (sodium hyaluronate) is incompatible with quaternary ammonium salts such as benzalkonium chloride.

ARTHRUM VISC 75 should never come into contact with these products or with surgical materials previously cleaned with them.

The physician must inform the patient of the potential immediate or delayed adverse effects related to the administration of this medical device before injection.

Check the expiration date indicated on the label. Do not reuse, sterility cannot be guaranteed. Do not resterilize. It is recommended to use sterile 21G (0.8 x 50 mm) needles with Luer tips and ensure their compatibility with Luer-Lock assemblies before use. Used needles and syringes must be disposed of in the appropriate waste collection containers according to current regulations. Store at a temperature between +2°C and 30°C. Protect from light and frost.

Contraindications

ARTHRUM VISC 75 should not be administered to:

• Patients hypersensitive to hyaluronic acid.
• Patients suffering from autoimmune diseases, sarcoidosis, severe multiple allergies, cardiovascular diseases taking anticoagulants.
• Patients taking immunosuppressants or interferon.
• Pregnant or breastfeeding women.
• Children.

ARTHRUM VISC 75 should not be used in case of inflammatory joint diseases (rheumatoid polyarthritis).

ARTHRUM VISC 75 should not be injected at the same time as injectable corticosteroids.

Side effects

Side effects Immediate injection-related side effects: pain, redness, swelling at the injection site.
Inflammatory side effects: pseudogout attack, chondrocalcinosis, pseudoseptic arthritis.
Other side effects: poor efficacy or poor treatment effect compared to a particularly advanced radiological stage of gonarthrosis.