Sinogel Injection Pre-filled syringe 3 ml Osteoarthritis

Each box of Sinogel Injection Seringue Préremplie 3 ml contains 1 pre-filled syringe (72.0 mg hyaluronic acid sodium salt and 48.0 mg chondroitin sodium in 3 ml physiological solution buffered with sodium chloride) and 1 needle 21 G x 1 ½" (0.8 x 40 mm).

Sinogel® is indicated for pain or reduced mobility due to degenerative diseases (osteoarthritis), post-traumatic diseases or alterations to joints and tendons. Sinogel® is a synovial fluid substitute, used to restore the physiological and rheological properties of osteoarthritic joints.

Directions for use Sinogel Injection Pre-filled syringe 3 ml Arthrosis

The expiration date indicates the shelf life of the medical device.

Shelf life: 36 months.

Store at room temperature below 25°C, away from sources of heat. Do not freeze.

Once opened, Sinogel should be used immediately.

After use, dispose of the product in an environmentally-friendly manner in accordance with local regulations.

Dosage Sinogel Injection Pre-filled syringe 3 ml Arthrosis

Sinogel is administered by intra-articular injection.

Aspirate any joint effusion before injection.

1. 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 21G 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 (figure B).

2. Inject at room temperature under strict aseptic conditions. An ultrasound-guided procedure is recommended for intra-articular injection into the hip. Inject only into the synovial space.

After treatment :

The physician should complete and give to the patient the implant card found on the first page of the package insert.

Dosage :

Sinogel is a single-dose preparation and should be injected only once per treatment cycle.

It is the physician's responsibility to assess the need for repeated treatment and its frequency for each patient, taking into consideration the benefit/risk balance of treatment in each case.

Population and intended users :

Sinogel is indicated for adults of both sexes and is administered by intra-articular injection.

Sinogel may only be injected by qualified personnel.

Contraindications

Do not inject in infected or severely inflamed joints, or in patients with skin disease or infection at the injection site.

Do not mix Sinogel with disinfectants such as quaternary ammonium salts or chlorhexidine to prepare the skin, as there is a risk of precipitating hyaluronic acid in the solution.

The injection site must be on healthy skin.

Do not use in patients suffering from autoimmune diseases.

Do not inject via the vascular route. Do not inject outside the joint cavity, into synovial tissue or into the joint capsule.

Do not administer Sinogel in the presence of profuse intra-articular effusion.

Do not use Sinogel in the event of known hypersensitivity or allergy to the product's components.

After injection, patients should be advised to avoid strenuous physical activity and to wait a few days before resuming normal activities.

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 resterilize. This device is for single use only.

Do not reuse to avoid any risk of contamination.

The presence of any air bubbles does not affect the product's characteristics.

Keep out of sight and reach of children.

Do not use Sinogel beyond the expiry date indicated on the packaging.

Do not use Sinogel if the packaging is opened or damaged because the sterility of the product could be compromised.

Undesirable effects :

Extra-articular infiltration of Sinogel may cause local side effects.

When using Sinogel, you may experience symptoms such as pain, warmth, redness or swelling. These side effects can be relieved by applying ice to the treated area. In most cases, these effects disappear fairly quickly.

It is imperative that doctors ask their patients to keep them informed of any adverse effects occurring after treatment. In the event of an incident, inform the manufacturer or the relevant authorities.

Interactions :

To date, there are no known interactions between Sinogel and other drugs/treatments. However, in the case of therapies and/or drugs taken in conjunction with treatment, consult your doctor for further information.

Fertility/pregnancy/breast-feeding

Not for use by pregnant or breast-feeding women.

Composition Sinogel Injection Pre-filled syringe 3 ml Arthrosis

Hyaluronic acid 2.4%; chondroitin sodium 1.6%.

Functional components:

Hyaluronic acid sodium salt 72 mg

Chondroitin sodium 48 mg

Other components:

Sodium chloride 21.00 mg

Monobasic sodium phosphate 0.135 mg

Sodium phosphate dibasic 0.48 mg

Water for injections q.s. 3.0 ml