Description Sinovial HL 2 ml pre-filled syringe
Each box contains 1 x 2 ml pre-filled syringe (32 mg (H-HA) + 32 mg (L-HA) sodium hyaluronate in 2 ml buffered physiological sodium chloride solution) and a 21 G x 1½ " (0.8 x 40 mm) needle.
Properties Sinovial HL 2 ml pre-filled syringe
Sinovial HL is used in the treatment of osteoarthritis and is particularly indicated in cases of pain or reduced mobility due to degenerative diseases (osteoarthritis), post-traumatic diseases or tendinopathy linked to joint alterations. As a synovial fluid replacement agent, it helps restore the physiological and rheological properties of arthritic joints. Sinovial HL naturally restores the viscoelastic properties of synovial fluid, rapidly reducing pain and restoring mobility to joints and tendons. It acts only at the level of the joint into which it is injected, and has no systemic action.
Instructions for use Sinovial HL 2 ml pre-filled syringe
A maximum of three injections may be given, depending on the severity of the joint degeneration. It is the doctor's responsibility to assess the appropriateness of repeating the treatment and its frequency for each patient, taking into account the benefit/risk ratio of the treatment in each case.
Aspirate any joint effusion before injecting Sinovial HL.
Carefully unscrew the cap on the end of the syringe, holding the Luer-Lock connector firmly with your fingers and taking care to avoid contact with the opening.
While holding the syringe's Luer-Lock connector firmly, attach the 21 G needle (contained in the pack) by rotating it until a slight counter-pressure is felt, to ensure a tight connection and prevent any liquid leaking out during administration.
Inject only into the synovial space, at room temperature and under strict aseptic conditions.
Precautions for use
Intra-articular injection must only be performed by a doctor.
The contents of the pre-filled syringe are sterile. The syringe and needle are supplied in a sealed blister pack.
The outer surface of the syringe is not sterile.
Do not use the device beyond the expiry date indicated on the packaging.
Do not use the device if the packaging is open or damaged.
The skin at the injection site must be healthy.
Do not inject intravenously. Do not inject outside the joint cavity, into synovial tissue or into the joint capsule.
Do not administer Sinovial HL in the event of severe intra-articular effusion.
Do not resterilize. The device is designed for single use only.
Do not reuse to avoid contamination.
Keep out of sight and reach of children.
After intra-articular injection, patients should avoid strenuous physical activity and wait a few days before resuming normal activity.
The presence of an air bubble in no way affects the quality of the product.
Do not use at the same time as disinfectants containing quaternary ammonium salts or chlorhexidine to prepare the skin, as precipitation of hyaluronic acid is possible in their presence.
Mandatory information
Sinovial® HL is indicated for pain or reduced mobility due to degenerative
diseases (arthrosis), post-traumatic diseases or tendinopathy linked to
joint alterations. Read instructions carefully before use. Class III medical device. CE mark
0373. Manufacturer: IBSA Farmaceutici Italia. Not covered by LPPR
Date of publication or document update : June - 2019
Leaflet available here: https: //lagammevisco.fr/produit/sinovial-hl/
Contraindications Sinovial® HL
Sinovial® HL should not be injected into infected or severely inflamed joints, or into patients with skin disorders or infections at the injection site
Undesirable effects :
Extra-articular infiltration of Sinovial HL may cause local adverse effects. When using Sinovial HL, symptoms such as pain, warmth, redness or swelling may appear at the injection site. Applying ice to the treated joint may help relieve these side effects. They generally disappear rapidly. Physicians should ask patients to inform them of any adverse effects occurring after treatment.
Interactions :
No known interactions to date.
Based on the results of in vitro studies to date, there is no biological or chemico-physical interaction between Sinovial HL and platelet-rich plasma (PRP) injections used as infiltration for the treatment of osteoarthritis.
Storage conditions
Store between 0 and 25°C, away from sources of heat. Do not freeze.
Once opened, use immediately and discard after use.
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