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

4.1. Therapeutic indications

Suplasyn is indicated for the symptomatic treatment of osteoarthritis. Suplasyn has been shown to be beneficial in osteoarthritis for the management of pain and improvement in physical function of joints. Depending upon joint size, up to 2ml may be administrated intraarticulary. Use strict aseptic technique. More than one joint may be treated at the same time. Discard any unused portion of the syringe. To use the prefilled syringe, remove the Luer lock cap, attach a suitable cannula (recommended is 21-25G depending on joint) and secure it by turning slightly.

Hyaluronic acid is the prototype of a wide range of saccharide biopolymers (glycosaminoglycan sot mucopolysaccharides), important components of all extracellular tissue structures, including cartilage and synovial fluid. The active substance of Suplasyn is a hyaluronic acid of defined molecular chain length with a high degree of purity. The introduction of Suplasyn into the synovial space will assist in the normalization of the joint following arthrocentesis.

4.2. Posology and method of administration

Suplasyn is supplied as 2ml solution in a pre-filled syringe. The recommended schedule is 1 injection per week for 3 weeks, but up to 6 may be given depending on patient’s condition.

4.9. Overdose

There is no experience of overdose with Suplasyn.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store between 4°C and 25°C. Do not Freeze.

6.6. Special precautions for disposal and other handling

Do not inject intra-vascularly.

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

For Single Use Only. Do not use if blister is damaged. To be used by physician only.

Discard any unused portion of the syringe. Reuse may create a risk of contamination and/or cause patient infection of cross infection.

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