Hyaluron-BP - Prefilled Syringe

Sodium hyaluronate

One pre-filled syringe (2 ml) of solution for injection contains sodium hyaluronate 30 mg. Excipient with known effect: sodium 3.97 mg/ml. Colourless, viscous and clear solution.

Indication: Indicated as a viscoelastic supplement or substitute for synovial fluid in human joints, for the symptomatic treatment of degenerative conditions of synovial joints (such as osteoarthritis) in patients for whom non-pharmacological treatment and simple analgesics are ineffective.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− allergy (hypersensitivity) to any of the components of Hyaluron-BP
− pre-existing skin infections in the region of the injection site
− known infection of the affected joint
− known systemic bleeding disorders.
Hyaluron-BP may contain traces of proteins from gram-positive bacteria and is therefore contraindicated in patients with a history of such allergies.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
− Anaphylactoid and allergic reactions have been reported for sodium hyaluronate.
− Transient increases in inflammation of the injected knee have been reported after injection of sodium hyaluronate in some patients with inflammatory arthritis, such as rheumatoid arthritis or gouty arthritis.
− Patients should be carefully examined before administration of the product to detect signs of acute inflammation, and the physician must decide whether treatment with Hyaluron-BP should be initiated in this case.
− An increase in injection pressure may indicate incorrect extra-articular needle placement or excessive filling of the joint.
− Hyaluron-BP should be used with caution in patients with pre-existing chondrocalcinosis, since the injection may lead to an exacerbation of the condition.
− Hyaluron-BP should be used with caution in […]