Instructions for use SYNOLIS VA
Description
SYNOLIS VA is a viscoelastic, sterile, apyrogenic, isotonic, buffered 2% sodium hyaluronate solution. The sodium hyaluronate used in SYNOLIS VA is obtained by bacterial fermentation and has a high average molecular weight (MW) of 2 MDa. SYNOLIS VA has a neutral pH of 6.8–7.4, similar to synovial fluid.
A high concentration and high molecular weight of sodium hyaluronate combined with a polyol (sorbitol), which limits degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties similar to those of healthy synovial fluid. SYNOLIS VA works by restoring the physiological and viscoelastic properties of synovial fluid, which are progressively lost during the development of osteoarthritis (OA). SYNOLIS VA thus relieves local pain and discomfort caused by symptomatic OA and improves the mobility of synovial joints.
Introduction
SYNOLIS VA is available in two package sizes. Each box contains 1 syringe, traceability labels, and instructions for use. Each product includes an implant card for the patient to be completed by the physician.
| SYNOLIS VA 40/80 |
SYNOLIS VA 80/160 |
| pre-filled glass syringe with 2 ml viscous pain-relieving gel. |
pre-filled glass syringe with 4 ml viscous pain-relieving gel. |
Composition
Per 1 ml:
| Sodium Hyaluronate |
20 mg |
| Sorbitol |
40 mg |
| Buffered saline q.s.p. |
1 ml |
Sterilization method: Moist heat.
Indications
SYNOLIS VA is indicated for the treatment of symptomatic osteoarthritis (OA) to relieve pain and improve mobility after degenerative changes in synovial joints:
| SYNOLIS VA 40/80 |
SYNOLIS VA 80/160 |
| Knee joint |
Knee and hip joint |
This treatment is intended for patients who have not responded to conservative, non-pharmacological therapy and simple analgesics and/or NSAIDs, or who have intolerance to simple analgesics and/or NSAIDs.
Dosage, type, and duration of use
Treatment must be adjusted according to the patient's radiological and physical condition (Kellgren-Lawrence score, pain, and mobility). Existing clinical data have demonstrated efficacy for different injection schedules depending on the severity of osteoarthritis:
| Injection schedule / Severity of the disease |
Severe mild to moderate |
Severe moderate to severe |
| 1 injection of SYNOLIS VA 40/80 |
✓ |
|
| 1 injection of SYNOLIS VA 80/160 |
✓ |
✓ |
| 3 injections of SYNOLIS VA 40/80 at intervals of 1 week each |
|
✓ |
An additional injection of SYNOLIS VA can be given if OA symptoms reoccur or to maintain local pain treatment and joint function. However, in patients who respond to the treatment, the benefit is expected to last at least six months.
The interval before repeating the treatment regimen also depends on the physician's experience and/or the severity of the disease.
SYNOLIS VA should be injected into the synovial cavity by a physician trained in intra-articular (i.a.) injections. Several measures must be taken before injecting SYNOLIS VA:
- SYNOLIS VA should be at room temperature at the time of intra-articular injection.
- The injection site must be carefully disinfected.
- The physician is responsible for selecting an appropriate needle size (recommended size for knee joint injections: 18 to 21 G).
- The needle must be firmly attached to the Luer-Lock connection of the syringe.
- Inject precisely only into the joint cavity.
Contraindications
SYNOLIS VA must not:
- should not be injected into patients with known hypersensitivity or allergy to sodium hyaluronate and/or sorbitol preparations;
- should not be injected into patients with a skin disease or infection at the injection site;
- should not be injected intravascularly;
- should not be injected into pregnant or breastfeeding women;
- should not be injected into adolescents under 18 years of age.
Special precautions for use
- Before treatment, the patient must be informed about the product, its contraindications, and possible side effects.
- Use SYNOLIS VA only for symptomatic osteoarthritis.
- Due to the lack of available clinical data on the tolerability and efficacy of SYNOLIS VA in patients with a history of autoimmune disease, active autoimmune disease, or abnormal physiological conditions, the physician must decide on a case-by-case basis, depending on the type of disease and associated treatments, whether SYNOLIS VA can be injected. It is recommended to advise these patients to undergo a preliminary test and to avoid injection if the disease is active. Careful monitoring of these patients after injection is also recommended.
- Before use, check the integrity of the inner packaging and the expiration date. Do not use the product if the expiration date has passed or if the packaging has been opened or damaged.
- Do not transfer SYNOLIS VA into another container or add any other components to the product.
- Exercise caution when performing the intra-articular injection to avoid injecting outside the intra-articular joint cavity or into the synovial membrane. Viscosupplementation gels injected into the perisynovial area can be painful due to compression of surrounding tissues.
- Injection into an arm or leg joint with significant venous or lymphatic stasis is not recommended.
- Injection into an infected or severely inflamed joint is not recommended.
- In cases of severe joint effusions, the doctor must decide on a case-by-case basis whether SYNOLIS VA can be injected. The effusion must be aspirated before injecting SYNOLIS VA.
- Synolis VA is a single-use product and must not be used for multiple patients and/or multiple treatment sessions.
- The product must not be resterilized.
- Reusing single-use products can lead to infections as sterility is compromised. Only the gel is sterile, not the outside of the syringe.
- Synolis VA must be administered under strict aseptic conditions.
- Patients are advised to avoid strenuous physical activity for at least 48 hours after the injection.
- The product must be stored under the recommended storage conditions.
- Dispose of the syringe (and the needle selected by the doctor) according to recognized medical standards and in compliance with applicable national, local, and institutional requirements.
Interactions with other medicinal products
There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Therefore, SYNOLIS VA must never come into contact with such products (e.g., certain disinfectants) or with medical or surgical devices treated with such products. So far, no data are available on the compatibility of SYNOLIS VA with other products for intra-articular use.
Side effects
Side effects may occur and must be explained to the patient before treatment. Injection may cause slight bleeding, which stops spontaneously once the injection is completed. Occasionally, one or more of the following reactions may occur immediately or with delay. Temporary local pain, swelling, and/or joint effusions may occur. These reactions usually heal within a few days. If these symptoms last longer than a week or if other side effects occur, the patient must inform the doctor. The doctor may prescribe appropriate treatment for these adverse effects. Other possible typical side effects of visco-supplementation injections include inflammation, redness, swelling, skin irritation, allergic reactions, and tissue reactions.
Any serious incident related to the product must be reported to the manufacturer and the competent authority of the member state where the user and/or patient is established.
Storage
Store at 2 °C to 25 °C. Protect from light and extreme cold. Do not freeze the product.
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