SUPLASYN Solution for injection Ref.[50640] Active ingredients: Hyaluronate sodium

Source: Web Search  Publisher: <u>Manufacturer:</u> Mylan Institutional, Coill Rua, Inverin, Co. Galway, Ireland <u>Owner of the license:</u> Mylan Pharma Group Limited, Coill Rua, Inverin, Co. Galway, Ireland

4.4. Special warnings and precautions for use

Warnings

Do not inject intra-vascularly.

The patients should rest 24-48 hours after the injection and avoid any strenuous activity over the full course of the treatment.

Avoid using Suplasyn with instruments sterilised with quaternary ammonium salts solutions.

For Single Use Only.

Precautions

Transient short duration pain may occur following intra-articular introduction. The affected joint may show a mild local reaction like pain, feeling of heat, hyperthermia, redness, effusion, irritation and swelling/inflammation. If these symptoms occur, rest the affected joint and apply ice locally. Symptoms subside within days for most of the patients. In some cases, mild local reactions such as pain, irritation, swelling/joint inflammation and effusion may be significantly enhanced and much more severe as an expression of hypersensitivity. In such cases a therapeutic intervention could be necessary, e.g. aspiration of joint fluid.

Local adverse reactions could be accompanied by systemic reactions such as fever, chills, or cardiovascular reactions, and in rare cases anaphylactic reactions.

Discontinue use if adverse reactions are experienced.

4.5. Interaction with other medicinal products and other forms of interaction

Non known.

4.6. Pregnancy and lactation

As no clinical evidence is available on the use of Hyaluronic acid in children, pregnant and lactating women, treatment with Suplasyn is not recommended in theses patients.

4.8. Undesirable effects

Transient short duration pain may occur following intra-articular introduction. In some cases the effected joint may show a mild local reaction like pain, feeling of heat, hyperthermia, redness, effusion, irritation and swelling/inflammation. Local adverse reactions could be accompanied by systemic reactions such as fever, chills or cardiovascular reactions, and in rare cases anaphylactic reactions. In extremely circumstances rash/itching, urticarial, synovitis, and a drop in blood pressure have been reported following the administration of Suplasyn.

6.2. Incompatibilities

Avoid using Suplasyn with instruments sterilised with quaternary ammonium salts solutions.

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