Arthrovisc40®

Class III CE certified
Medical Devices

What is Arthrovisc40® ?

Arthrovis40® is a non-cross-linked hyaluronic acid (2 %) obtained from bacterial fermentation.

This product is sterile and non-pyrogenic.
It is packaged in 2 ml syringes of hyaluronic acid
( 20 mg/ml, 1500 KDa).

Arthrovisc40 is available in three syringes of 2 ml. It is for single use and designed to be used with sterile needles (25G or 27G), not supplied in the kit.

Composition :

2 mL of solution contains 40mg of hyaluronic acid in phosphate buffer (Sodium chloride, Dipotassium hydrogenphosphate, Potassium dihydrogenphosphate, Potassium chloride) and water for injection.

Storage :

Storage of the syringes must be in a range between +5°C to +30°C, keep away from humidity.

Intended use of the device

Intra-articular injections into the knee for symptomatic treatment of articular pain and mobility improvement.

Warnings and precautions

Contra-indications

Do not administer to patients with ascertained hypersensitivity to one of the components, or suffering from serious disease such as infection in joint. The administration to patients suffering from inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease is not recommended.
The administration of hyaluronic acid in children, pregnant or lactating women is not recommended.

Precautions:

Injections into the joint cavity must be performed with the same precautions as any other intra-articular injection, and if necessary using imaging control. The patient must respect a delay of 1h without physical activity after the injection, and avoid strenuous or weight bearing activities for 48 hours following the intra-articular injection.

General precautions:

The patient must be informed about the general risks associated with the treatment and of possible adverse effects. Injections must be performed by the physician and under his responsibility. The physician must be familiar with the equipment and with the procedure before using the kit. Strict aseptic injection technique must be followed. Use appropriate safety precautions to protect yourself from needles. Do not recap the needle after use and discard directly in the biological hazard container. Throw away each syringe and remaining HA gel after use, using the method of elimination for potentially contaminated products. Do not inject intravenously or for any other application than described in the intended use. Do not use if the packaging or syringes are open or damaged. Do not use after the expiry date. This product is for single use only: do not re-use.

If the plunger is blocked during injection, do not force it; the injection must be aborted. The physician must evaluate the need to adapt the treatment protocol according to the volume of hyaluronic acid gel that was injected.

Possible side effects

Injection may cause damage of the blood vessels and haematomas. Local secondary inflammatory reactions may occur at the site of injection. This may result in phenomena such as temporary pain, feeling of heat, redness and swelling in the treated joint. There have also been occasional reports of hyper-sensitivity, including, rarely, anaphylaxis. Ice-packs application in the minutes following the injection, or local analgesic treatment the day following the injection may decrease these inconveniences.

Patented by Regen Lab SA
Arthrovisc40®

Pending WO2019155391
WO2013/061309

All our Patent

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