Biolevox HA 2.2%, 1 pre-filled syringe of 2 ml

Composition:

1 ml contains:

• Sodium Hyaluronate - 22,000mg
• Sodium chloride - 8,500mg,
• Disodium hydrogen phosphate - 0.563mg
• Sodium dihydrogen phosphate - 0.042mg
• Water for injections - qs

Description:

• Biolevox HA 2.2% with pH 6.8-7.4 contains high molecular weight sodium hyaluronate, obtained by bacterial fermentation, of non-animal origin.
• The product has been sterilized and is non-pyrogenic.
• The product is intended for depot injection to increase the viscosity of synovial fluid.

Indication:

• Painful conditions and limited joint mobility resulting from post-traumatic or degenerative lesions (osteoarthritis).

Contraindication:

The product should not be used in patients:

• with known hypersensitivity to any component of the product;
• with septic arthritis;
• with dermatosis at the site of the planned injection; taking anticoagulants.

Safety precautions:

All precautions should be taken when performing the procedure to prevent the development of septic arthritis.

The product is intended for delivery injection only.

• Do not use products containing quaternary ammonium salts to disinfect the skin before injection, as their presence may precipitate hyaluronate. Due to insufficient clinical data, the product should not be used in children and women during pregnancy and lactation.
• Do not use the product if the sterile pre-filled syringe is damaged.
• Do not use the product after the expiry date stated on the packaging.
• The product cannot be resterilized.
• The pre-filled syringe is intended for use on one patient during a single treatment session.

Storage:

• Store at a temperature of -2°C to +25°C.
• Protect from moisture and sunlight.
• Keep the product out of the reach of children.

Possible side effects:

• Biocompatibility studies have confirmed the high safety of the product.
• Transient symptoms such as pain, redness and swelling may occur at the injection site.
• These symptoms can be reduced by cooling the injection site for 5-10 minutes after application using a cooling bag.
• For pain, the simultaneous use of oral analgesics and anti-inflammatory agents may be beneficial.

Interaction:

• No data have been presented to date on complications or side effects due to the reaction of the product with other solutions used for delivery.

How to use:

• Disinfect the skin at the intended injection site. Remove the pre-filled syringe from the packaging, remove the Luerlock from the syringe and screw the appropriate sterile needle (21G) onto it. Remove any air bubbles before injection.
• The therapy consists of a cycle of three booster injections, administered at weekly intervals.
• The effects of the treatment last for at least six months. The treatment cycle can be repeated as needed.

Properties and mechanism of action:

• Sodium hyaluronate is responsible for the viscosity and elasticity of synovial fluid. Thanks to its lubricating and cushioning properties, it enables painless, physiological movement in the joint. In addition, it supplies the articular cartilage with nutrients.
• Replenishment of synovial fluid with sodium hyaluronate injections improves the elasticity and viscosity of the synovial fluid. In this way, after just one injection, joint mobility improves and the level of noticeable pain that occurs due to damage to the articular cartilage is reduced.

Package contents:

• Sterile pre-filled syringe containing 2 ml of colourless gel, in a blister pack and a sterile needle (21G).

Important:

• This is a medical device. Use it according to the instructions for use or the label.
• Medical device - has CE marking 1434
• Does it have an EU declaration of conformity?
• Includes user manual in Polish
• Contains a label in Polish
• Storage and transportation of medical devices is in accordance with the conditions set by the manufacturer.