Description Sinovial® HL :
Each box contains 1 pre-filled syringe of 2 ml (32 mg (H-HA) + 32 mg (L-HA) of sodium hyaluronate in 2 ml of buffered physiological sodium chloride solution) and a 21 G x 1½ " (0.8 x 40 mm) needle.
Properties of Sinovial® HL
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 related to joint alterations. As a substitute for synovial fluid, it restores the physiological and rheological properties of arthritic joints. Sinovial HL naturally restores the viscoelastic properties of the synovial fluid, thus rapidly reducing pain and restoring the mobility of joints and tendons. It acts only at the level of the joint into which it is injected and has no systemic action.
How to use Sinovial® HL
A maximum of three injections may be given in the course of treatment, depending on the severity of the joint degeneration. It is the responsibility of the physician to assess the appropriateness of repeat treatment and 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 Luer-Lock connector of the syringe firmly, attach the 21 G needle (contained in the package) by rotating it until a slight back pressure is felt to ensure a tight connection and to prevent leakage of fluid during administration.
Inject only into the synovial space, at room temperature and under strict aseptic conditions.
Precautions for use
Intra-articular injection should only be performed by a physician.
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 after the expiry date indicated on the package.
Do not use the device if the package is opened or damaged.
The skin at the injection site must be healthy.
Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule.
Do not use Sinovial HL if there is significant intra-articular effusion.
Do not resterilize. The device is intended for single use only.
Do not reuse to avoid contamination.
Keep out of reach and sight of children.
After intra-articular injection, recommend that the patient avoid strenuous physical activity and wait a few days before resuming normal activity.
The presence of an air bubble does not affect the quality of the product.
Do not use 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
(osteoarthritis), post-traumatic diseases or tendinopathy related to changes in
joints. Read the instructions carefully before use. Medical device Class III. CE marking
0373. Manufacturer: IBSA Farmaceutici Italia. Not covered by the LPPR
Date of edition or update of the document : June - 2019
Leaflet available here: https: //lagammevisco.fr/produit/sinovial-hl/
Contraindications Sinovial® HL
Sinovial® HL should not be injected in infected or severely inflamed joints or in patients with skin disease or infection at the injection site
Adverse reactions:
Extra-articular infiltration of Sinovial HL may cause local adverse effects. When using Sinovial HL, symptoms such as pain, warmth, redness or swelling may occur at the injection site. Applying ice to the treated joint may help to relieve these side effects. They usually disappear quickly. The physician should ask patients to inform him/her of any adverse events that occur after treatment.
Interactions :
No known interactions at this time.
Based on the results of in vitro studies performed to date, there are no biological and chemical-physical interactions between Sinovial HL and platelet-rich plasma (PRP) injections used as infiltration for the treatment of osteoarthritis.
Storage Conditions
Store at 0-25°C away from heat sources. Do not freeze.
Once opened, use immediately and discard after use.
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