DESCRIPTION

ARTHROMAC® is a sterile, transparent, colourless, homogeneous, viscoelastic, nonpyrogenic, physiological solution of highly purified high molecular weight sodium hyaluronate of non-animal origin.

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COMPOSITION

Water for injection, sodium hyaluronate (20 mg/mL), sodium chloride.

 

INDICATIONS

ARTHROMAC® is indicated for the symptomatic treatment of mild to moderate osteoarthritis. ARTHROMAC® treats pain and restricted mobility as a result of degenerative or traumatic pathology in the joint.

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MODE OF ACTION

ARTHROMAC® acts as a temporary replacement and supplement for synovial fluid to relieve joint pain, improve articular mobility and protect cartilage. 

ARTHROMAC® restores a good lubrication and shock absorption in the joint and provides a significant and long-term pain and stiffness relief. ARTHROMAC® is biodegradable and is slowly reabsorbed over time.

 

ADMINISTRATION

- The product is administered by intraarticular injection.

- Do not inject the product extraarticularly. 

- Do not inject the product in the joint of patients having infections or skin diseases in the area of the injection site. 

- Strict aseptic administration technique must be followed. 

- Injection site must be properly disinfected (70% alcohol or with another disinfectant). Disinfectants containing quaternary ammonium salts should not be used for skin preparation as hyaluronic acid can precipitate under such conditions. 

- Remove joint effusion before injection. Arthrocentesis prior to injection is recommended.

- After removal of the 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.

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PRECAUTIONS FOR USE

- Verify the expiry date and the integrity of the packaging before use. Do not use if the expiry date is exceeded or if the packaging is damaged.

- At the end of the treatment, it is essential to discard all used needles and syringes.

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PROPERTIES AND EFFICACY

ARTHROMAC® is a product for viscosupplementation, which is a safe, effective and well-established treatment in OA consisting in injecting a hyaluronic acid-based solution into the affected synovial joint. Hyaluronic acid (HA) is a major component of the synovial fluid and cartilage, and, thanks to its viscoelastic and rheological properties, is responsible of the lubrication and cushioning in joints. It decreases friction between joint surfaces and protects soft tissue from trauma by acting as a shock absorbant. HA also have analgesic, anti-inflammatory, antioxidant and chondroprotective effects, stimulates proteoglycan synthesis, and facilitates the evacuation of cartilaginous remains. The quantity and quality of HA in the synovial fluid are reduced in the patients who have osteoarthritis because its synthesis by the synovial and cartilage cells is disturbed. The protection of articular surfaces thus is strongly altered, the cartilage becomes vulnerable and exposed to structural degradations due to the forces of friction and compression. Administered by a single injection, ARTHROMAC® will restore a good lubrication and shock absorption in the joint and will provide a significant and long-term pain and stiffness relief.

 

SHELF LIFE AND STORAGE

As indicated on package. The expiration date is 36 months from the date of manufacturing. Store between +2°C and +25°C and away from light. Do not freeze.

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ADVERSE EVENTS

No specific adverse events are reported through use of ARTHROMAC®. However, common adverse reactions such as itching, redness, swelling and pain may occur at the injection site. Application of ice to the treated joint may relieve these

symptoms. These symptoms generally decrease within a short period.

 

HOW SUPPLIED

ARTHROMAC® is supplied in a sterile glass prefilled syringe containing 3 mL of solution packed in a sterilized medical grade blister.

 

EXPLANATION OF INTERNATIONAL SYMBOLS

 

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