HYALGAN Solution for injection Ref.[7901] Active ingredients: Hyaluronate sodium

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Multi-pharm Co Ltd, 24, Apollonos Str., 1046, Nicosia, Cyprus

4.3. Contraindications

  • Hypersensitivity to the active ingredient or to any of the excipients.
  • Case history of allergy to poultry proteins.
  • Severe liver conditions.

4.4. Special warnings and precautions for use

  • Intra-articular infiltrations must be performed by qualified medical operators, according to the technique and conditions of asepsis prescribed for this type of administration. Special precautions must be taken in the case of patients with ongoing infections near the injection site, in order to avoid the possible onset of bacterial arthritis.
  • If joint effusion is present, it is advisable to aspirate it before injecting HYALGAN.

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

Hyaluronic acid interacts with some local anaesthetics, prolonging the anaesthesia time.

4.6. Pregnancy and lactation

Although no embryotoxic or teratogenic effects have emerged from experiments on animals, the use of the drug in pregnant or nursing mothers should be limited to cases judged by a doctor to be absolutely necessary, after careful assessment of the risk-benefit ratio.

4.7. Effects on ability to drive and use machines

HYALGAN does not affect the ability to operate machinery or drive a motor vehicle.

4.8. Undesirable effects

It is possible, in some rare cases, that the patient may briefly experience a moderate degree of pain immediately after the injection; in such cases it is advisable to rest the joint and applied ice pack locally.

In the presence of objective signs indicating flare of the underlying, chronic, inflammatory process, the administration of hyaluronic acid has, in some rare cases, caused an exacerbation of the condition.

From the time the product was first marketed to date, some rare case of hypersensitivity reaction have been reported.

6.2. Incompatibilities

The product should not be mixed with other drugs, with the exception of those specified in section 6.6.

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