Each mL contains sodium hyaluronate BP 10 mg, sodium chloride USP 8.5 mg, disodium hydrogen phosphate dihydrate USP 0.28 mg, sodium dihydrogen phosphate monohydrate USP 0.04 mg, water for injection USP q.s.
SYNOVAR is sterile, non-pyrogenic, transparent, viscoelastic preparation of highly purified, non-inflammatory, high molecular weight fraction of sodium hyaluronate. SYNOVAR contains 10 mg/mL of sodium hyaluronate BP dissolved in physiological sodium phosphate buffer (pH 7.0-7.5). This polymer consists of repeating disaccharide units of N-acetyl-glucosamine and sodium glucuronate linked by β 1-3 and β 1-4 glycoside bonds.
Pharmacology: Pharmacodynamics: Hyaluronic acid is an important component of the body's extracellular matrix and is present in a particularly high concentration in cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, which is fundamental for its lubricating and shock absorbing properties, and it is essential for the correct structure of proteoglycans in articular cartilage. In osteoarthritis there is an insufficient amount of, and a change in the quality of, hyaluronic acid in synovial fluid and cartilage. The intra-articular administration of hyaluronic acid into arthritic joints with degenerating cartilage surfaces and pathologically altered synovial fluid improved joint functions. The observed beneficial effects of exogenous hyaluronic acid may be related to its interactions with various components of the synovial cavity (synoviocytes and chondrocytes).
Pharmacokinetics: Sodium hyaluronate administered intra-articularly is eliminated from the synovial fluid within 2 to 3 days. Sodium hyaluronate is quickly distributed to the synovial membrane. The high concentrations of hyaluronic acid have been detected in the synovial fluid and the articular capsule, followed by, in decreasing order, the synovial membrane, the ligaments and the adjacent muscle. Hyaluronic acid in synovial fluid has been show to be not significantly metabolized. Animal studies have been shown that some degradation occurs in the tissue surrounding the joints,but the major site for metabolisation is the liver and excretion is mainly through the kidneys.
SYNOVAR is indicated for the treatment of pain in osteoarthritis (OA) of the knee and other synovial joints, in patients who have failed to respond adequately to conservative non-pharmacologic therapy, and to simple analgesics.
SYNOVAR is administered by intra-articular injection. A treatment cycle consists of three to five injections given at weekly intervals. Several joints can be treated simultaneously.
Administration: Strict aseptic administration technique must be followed. Inject subcutaneous lidocaine or similar local anesthetic prior to injection of SYNOVAR.
Aspirate joint effusion before injection of SYNOVAR. Do not use the same syringe for removing joint effusion and for injection of SYNOVAR.
Take care to remove the tip cap of the syringe and needle aseptically. Inject SYNOVAR in to the joint through a 19-gauge needle.
The syringe is intended for single use. The contents of the vial must be used immediately once the container is opened. Before injection, the air bubble is removed from the injection.
Injection the full 2.0 mL or 2.5 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.
Seek emergency medical attention if patient has received too much of this medicine.
SYNOVAR is contraindicated in patients with known history of hypersensitivity (allergy) to sodium hyaluronate (hyaluronan) preparations.
SYNOVAR is contraindicated in patients with knee joint infections or skin diseases in the area of injection site.
Do not use concomitantly disinfectants containing quaternary ammonium compounds for skin preparations because sodium hyaluranate is precipitated in their presence.
Do not inject SYNOVAR extra-articularly or into the synovial tissues and capsules. This will generally result in local and systemic adverse events.
Intravascular injections of SYNOVAR may lead to systemic adverse events.
The effectiveness of a single treatment cycle of less than 3-5 injections has not been established.
The effectiveness and safety of the use of SYNOVAR in joints other than knee have been established.
The safety and effectiveness of the use of SYNOVAR concomitantly with other intra-articular injectables have not been established.
Strict aseptic administration technique must be followed.
The safety and effectiveness of the use of SYNOVAR in severely inflamed knee joints have not been established.
The pre-filled syringe is intended for single use. Use the content of the syringe immediately after its packaging is opened. Discard any unused SYNOVAR.
Opened or damaged packages of SYNOVAR should not be used. Always store in the original packaging (protected from light) at 25°C. Do not freeze.
Aspirate synovial effusion if present before each SYNOVAR injection.
SYNOVAR should be used with caution when there is evidence of lymphatic or venous stasis in that leg.
SYNOVAR should be used with caution in diabetic patients with chronic disorders.
Transient pain, and/or swelling of the joint may occur after intra-articular injection eg, SYNOVAR.
In some case effusion may be considerable and can cause pronounced pain. Discuss with the physician if the swelling is extensive.
As with any invasive joint procedure, patient should avoid any strenuous activities or prolonged weight bearing such as jogging or playing tennis following the intra-articular injection.
The safety and effectiveness of SYNOVAR have not been established in pregnant women, lactating women and children.
Intra-articular injection may lead to local side effects like pain, heat sensation, redness and swelling at the injection site. Placing an ice pack on the injection site for 5 to 10 minutes would reduce the occurrence of such side effects.
Concomitant Intraarticular Injections: Do not co-administer with other intra-articular injectables. Safety and efficacy have not been established.
Local Anesthetic: Injection of subcutaneous lidocaine or other local anesthetic may be recommended prior to injection of SYNOVAR. Do not inject anesthetics intraarticularly into the knee with SYNOVAR. Because this may dilute SYNOVAR and affect its safety and efficacy.
Store at 25°C and protect from light. Do not freeze.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj (pre-filled syringe) 10 mg/mL x 2 mL, 2.5 mL.