Intended use of the device
Hyaluronic acid gel for intra-articular injections in the knee for the symptomatic treatment of joint pain and improvement of mobility.
Contraindications
Do not administer to patients with proven hypersensitivity to one of the components, or who suffer from a serious illness such as joint infection or acute/local infection at the procedure site. Administration is not recommended to patients suffering from inflammatory joint diseases such as rheumatoid arthritis or Bechterew’s disease.
The administration of hyaluronic acid to children, pregnant or lactating women is not recommended.
Precautions
Injections into the joint cavity should be performed with the same precautions as any other intra-articular injection and, if necessary, using image monitoring. The patient must respect a delay of 1 hour without physical activity after the injection, and avoid strenuous or weight-bearing activities for 48 hours following the intra-articular injection.
The patient should be informed about the general risks associated with the treatment and possible adverse effects. Injections must be performed by the doctor and under his/her responsibility. The doctor must be familiar with the equipment and the procedure before using the kit. Strictly aseptic injection technique must be followed. Use proper safety precautions to protect yourself from needles. Do not recap the needle after use and dispose of it directly in the biohazard container. Discard each syringe and remaining HA gel after use, using the disposal method for potentially contaminated products. Do not inject intravenously or for any application other than as described in the intended use. Do not use if packaging or syringes are open or damaged. Do not use after the expiration date. This product is for single use only: do not reuse.
If the plunger becomes blocked during injection, do not force it; the injection should be stopped. The doctor must evaluate the need to adapt the treatment protocol according to the volume of hyaluronic acid gel that was injected.
Possible side effects
The injection may cause damage to blood vessels and bruising. Local secondary inflammatory reactions may occur at the injection site. This can cause phenomena such as temporary pain, a sensation of heat, redness and swelling in the treated joint. There have also been occasional reports of hypersensitivity, including, rarely, anaphylaxis. The application of ice packs in the minutes following the injection or local analgesic treatment the day after the injection can reduce these inconveniences.
