ARTHROMAC is a sterile, nonpyrogenic, viscoelastic gel containing a highly purified specific fraction of non-animal, cross linked sodium hyaluronate.
Hyaluronic acid (20mg/ml), Sodium chloride, water for injection.
- Symptomatic treatment of mild to moderate Osteoarthritis.
- Treats pain and restricted mobility as a result of degenerative or traumatic pathology in the knee joint and other synovial joints (hip, ankle, shoulder, elbow, wrist, fingers, toes, and the temporomandibular and facet joints.
- Reduction of post-arthroscopic pain.
- ARTHROMAC acts as a temporary replacement and supplement for synovial fluid to relieve joint pain, improve articular mobility and protect cartilage.
- Administered by a single injection, ARTHROMAC restores a good lubrication and shock absorption in the joint and provides a significant and long-term pain and stiffness relief.
>3 MDA in the sterilized product
Pain relief, mobility improvement, cartilage protection
Up to 9 months
Single intraarticular injection. The product is administered by intraarticular injection. Do not inject the product extraarticularly.
- Only one injection The single injection regimen reduces patient inconvenience.
- Non-animal origin ARTHROMAC® is manufactured from a HA obtained by biofermentation and of the highest purity attainable.
- Full biocompatibility ARTHROMAC® is completely natural, biocompatible, bioresorbable and non-allergenic.
- Simple, quick, with no downtime The procedure takes only few minutes and daily routine can be resumed immediately after the injection.
- Non-surgical treatment ARTHROMAC® is an office-based procedure that helps to avoid or delay the need for major surgery.
- Drug-free and non-systemic ARTHROMAC® avoids the adverse and undesirable effects linked to the use of NSAIDs andcorticosteroids or associated with systemic administration.
- Non-toxic cross-linking system ARTHROMAC® is cross-linked through a proprietary technology without any toxic agents such as BDDE, formaldehyde, divinyl sulfone etc. which are used by numerous competitors.
- Minimum rate of adverse events Clinical and practice data indicate that ARTHROMAC® has a lower rate of adverse events in comparison with other competitors.
- Rigorous control of the manufacturing process ARTHROMAC® is manufactured in France under the highest quality standards with top qualified engineers and latest technology.
- Long-term pain relief The beneficial effects can last up to a year.
- Multi-action treatment ARTHROMAC® lubricates and cushions the joint, provides analgesic, anti-inflammatory, antioxidant andchondroprotective effects, stimulates proteoglycan, collagen and HA synthesis, and facilitates the evacuation of cartilaginous debris.
- Resistance to degradation Thanks to a proprietary cross-linking technology, ARTHROMAC® provides enhanced viscoelastic properties and a better resistance to enzymatic, oxidative, thermal and mechanical degradations.
- Optimal molecular weight.Protected from structural damages thanks to a proprietary sterilization process, the HA in ARTHROMAC® has an optimal average size in terms of beneficial effects on the extracellular matrix.
- Localized treatment ARTHROMAC® directly targets the affected joint with a therapeutic action entirely concentrated into the zone to be treated.
- Repeatable therapy The injection of ARTHROMAC® can be re-performed when the symptoms return. – Extended indication.ARTHROMAC® is approved for all synovial joints (particularly the knee and hip, but also the ankle, shoulder, elbow, wrist, fingers, toes, and the temporomandibular and facet joints) and for post-surgical management (particularly for reducing post-arthroscopy pain).
Contraindications Arthromac should not be injected:
- If there is a skin disease or infection present at or near the injection site.
- If the knee joint is infected or severely inflamed. Precaution
- Verify the expire date and the integrity of the packaging before use. Do not use if the expiry date is exceeded or if thepackaging is damaged.
- At the end of the treatment, it is essential to discard all used needles and syringes.
Injection site must be properly disinfected (70% alcohol or with another disinfectant). Disinfectant containing quaternaryammonium salts should not be used for skin preparation as hyaluronic acid can precipitate under such condition.
- Remove joint effusion before injection. Arthrocentesis prior to injection is recommended.
- After removal of tip cap, securely attach to the syringe an appropriately sized sterile needle (17 to 22 gauge), depending on the joint to be treated.
- The amount of Arthromac to be injected depends on the joint size. Do not overfill the synovial space.
- Each prefilled syringe is for single use only. The contents of the syringe should be used immediately after opening. Discard any unused Arthromac. Do not resterilize.
- The administration of Arthromac is reserved for medical practitioners trained in joint injection techniques.
- Injection of subcutaneous lidocaine or similar anesthetic may be recommended prior to injection of Arthromac.
- As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or tennis within the 48 hours that follow the intraarticular injection.
Swelling and transient pain may occur after injections. These reactions generally subside over 72 hours.
Store between 2°C and 25°C and away from sun light. Do not freeze.
Arthromac is supplied in a sterile glass prefilled syringe containing 3 ml of solution packed in a sterilized medical grade blister.
Novatex Bioengineering SAS, / France.
Farnoush Darou Teb Co.