Synoz®

1% Sodium salt of hyaluronic acid for intra-articular use

Packaging:

• ready-to-use 2 ml pre-filled syringe

Brief description:

• these are injections with hyaluronic acid, intended for intra-articular viscosupplementation,
• contains hypoallergenic hyaluronic acid - obtained by bacterial fermentation from bacteria and Streptococcus equi
• is a sterile, isotonic, viscoelastic solution for intra-articular use in the form of a ready-to-use pre-filled syringe,
• Final steam sterilization ensures 100% sterility.

Synoz is a sterile, isotonic, viscoelastic solution for intra-articular use in a ready-to-use syringe. One ready-to-use syringe contains 2 ml of viscoelastic solution. 1 ml of the product contains 10 mg (1%) sodium hyaluronate, sodium chloride, disodium phosphate, citric acid, and water for injection. The product is sterile and intended for single use only. The product is steam sterilized in a blister. No animal-derived materials are used in the production process, nor are they used as raw materials. The product does not contain any pharmacologically active substances.

• 1% Sodium salt of hyaluronic acid for intra-articular use,
• ready-to-use 2 ml pre-filled syringe,
• contains hyaluronic acid with an average molecular weight of 1.6 million daltons.

Physicochemical properties:

• Concentration: 10 mg/ml (1%) sodium hyaluronate,
• A 2 ml syringe contains 20 mg of hyaluronic acid,
• Molecular weight approximately 1.6 million daltons,
• Osmolarity 280 - 330 mOsmol/l,
• Pyrogens < 0.5 EU/ml,
• pH 6-8 - 7.6.

Indications:

Synoz can be administered to the selected joint depending on the individual patient's needs, the area and the pathology to be treated.

Possibility of use:

• Degenerative joint disease (OSTEOARTHRITIS),
• Pain and limited joint mobility resulting from injuries or joint overloads,
• Others according to the assessment of the attending physician and the patient's condition.

Effects and mechanism of action:

In patients with degenerative joint disease (osteoarthritis), the viscoelasticity of the synovial fluid is significantly impaired. This causes mechanical stress on the joint and leads to joint cartilage loss, resulting in limited joint mobility and pain during movement. The product's lubricating and cushioning effects help reduce pain and improve joint mobility. This effect can persist for several months after a treatment course of three to five intra-articular injections.

How to use:

• Depending on the size of the joint, a maximum of 2 ml of the product can be administered intra-articularly,
• In the case of the knee joint, 3 to 5 injections are recommended at weekly intervals,
• In the case of the hip, ankle and shoulder joints, 3 to 5 injections are recommended at weekly intervals,
• Treatment can be performed on several joints simultaneously.
• Treatment cycles can be repeated.

Contraindications and possible interactions:

This product should not be used in patients with hypersensitivity to any of its ingredients. Because the product is administered by intra-articular injection, patients with bacterial arthritis should be excluded from treatment to prevent possible complications. Currently, there are no data on adverse interactions with other agents administered intra-articularly.

Adverse reactions and events:

After applying this product, patients may experience local discomfort in the treated joint (pain, warmth, redness, and swelling). The following adverse events have been observed with similar products: mild to moderate arthralgia, in rare cases rash, aseptic joint effusion, pruritus, and muscle cramps. In very rare cases, the following adverse events have also been reported: allergic reactions, anaphylactic shock, haemarthrosis, phlebitis, pseudosepticemia, severe acute inflammatory reaction, nasopharyngitis, joint stiffness, Achilles tendonitis, bursitis, fever, and myalgia.

Warnings:

Injections should only be administered by a physician trained in intra-articular injections. This physician should be aware of all immunological and other potential risks associated with the use of biological material. This product has not been tested on pregnant women or children under 18 years of age. Keep this medicine out of the sight and reach of children. This product is intended for single use only. Under no circumstances should the syringe be re-sterilized. Reusing the product poses a potential risk of infection to patients or users. Do not use if the blister is open and/or damaged. Do not use the syringe if the tip cap in the blister is open or dislodged. Do not use the product after the expiration date. Instruct the patient to remain relatively still (but not motionless) for 24 hours after each injection to avoid stress on the treated joints.

Storage:

The product should be stored at room temperature (2-25°C/36-77°F) and protected from frost and moisture.

Medical device.

PRODUCER
KYERON BV
PO Box 1069
7500 BB Enschede
The Netherlands
www.kyeron.nl

EXCLUSIVE DISTRIBUTOR FOR POLAND
Activlab Pharma
REGIS
Walerego Sławka Street 3a
30-633 Krakow
www.activlabpharma.pl

Due to the specific nature of the product, we suggest shipping in controlled conditions (UPS COURIER - PLN 44), any other form of shipping is chosen at the buyer's risk.