Sinodrial

Indications:

SINODRIAL® is a substitute for synovial fluid which, thanks to its viscoelastic and lubricating properties, promotes the restoration of rheological conditions of altered joints in patients affected by degenerative osteoarthritis. By improving the characteristics of synovial fluid, the product exerts a protective action on joints, resulting in improved articular function and the reduction of pain symptoms. SINODRIAL® acts only at the level of the joint into which it is injected, without exerting any systemic action.

Product Description:

SINODRIAL® is a sterile, injectable, biodegradable and isotonic gel, for intra-articular use. SINODRIAL® consists of a hyaluronic acid with molecular weight of (2,5 - 3,5 x 106 Dalton), obtained from Streptococcus equi bacteria and amino acids (L-proline, L-hydroxyproline, Glycine, L-lysine HCL), formulated at a concentration of 25 mg/ ml in a physiological buffer. SINODRIAL® is characterised by viscoelastic properties, therefore it favours the normalisation of the viscosity of the synovial fluid in the intra-articular cavity. Each package contains two vial-syringes of SINODRIAL® and a product leaflet. Inside the package, there are two sets of labels displaying the lot number and the expiration date. One of these labels should be affixed to the patient’s medical file, while the other should be given to the patient to ensure traceability.

Composition:

Sodium hyaluronate 25 mg/ml, L-proline, L-hydroxyproline, Glycine, L-lysine HCL, sodium phosphate monobase dihydrate, dibasic sodium phosphate dodecahydrate, WFI water.

Package Content:

2 pre-filled syringes, each containing 2ml/50mg of non-pyrogenic gel, sterilised using moist heat. FOR MEDICAL USE ONLY.

Methods of use:

Remove any joint effusion before injecting SINODRIAL®.

Remove the protective syringe cap, paying particular attention to avoid contact with the opening. Firmly screw the 20 to 22 G diameter needle to the Luer Lock fitting, following the instructions below. Before injection, treat the site with an appropriate disinfectant. Inject SINODRIAL® by adopting an aseptic technique. Inject only into the intra-articular cavity. The use of SINODRIAL® is at the discretion of the physician. SINODRIAL® should be used according to the needs of the individual patients and the area to be treated.

Warnings – Precautions for use:

SINODRIAL® is indicated only for intra-articular injections and should only be dispensed by physicians who have received specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed above. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory skin conditions near the site of the infiltration site. Following the intra-articular injection, the patient should be advised to avoid physical activities that are demanding on the joint and to resume normal activities after a few days.

CAUTION: the outside of the syringe is not sterile.

SINODRIAL® has not been tested on pregnant or breastfeeding women. Thus, its use is not recommended in these cases. SINODRIAL® should not be used on patients under 18 years of age. Since SINODRIAL® is a single use product, the quality and sterility are guaranteed only if the syringe is originally sealed. Any residual product, therefore, should be disposed of and not reused even after a new sterilisation. Do not use the product if the packaging has already been opened or if it is damaged. After use, dispose of the syringe into a suitable container according to the current legislation.

Side effects:

Some temporary side reactions may occur following the injection of SINODRIAL®, such as pain, stiffness, warm sensations, redness or swelling. These secondary manifestations may be relieved by applying ice to the treated joint. Normally, these effects disappear after a short time. If symptoms persist, consult a physician. Any other undesirable side effects associated with the injection of SINODRIAL® should be reported to a physician. As with any intra-articular treatment, septic arthritis may rarely occur when general injection precautions are not observed, or the site of injection is not aseptic.

Incompatibilities:

There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact
between SINODRIAL® and these substances.

Storage:

Store SINODRIAL® at 2-25°C (36-77°F) in a dry place in its original packaging.
Protect from light, heat and extreme cold conditions. Keep out of the reach of children.