Each mL Contains: Sodium Hyaluronate 8 mg, Sodium Chloride 8.5 mg, Di-sodium Hydrogen Phosphate Dihydrate 0.16 mg, Monosodium Phosphate Monohydrate 0.04 mg, Water for Injection q.s.
Contains no preservatives.
HYORTH XL is a sterile, clear, viscoelastic preparation containing non-pyrogenic, high molecular weight (average 6 million Dalton), non-inflammatory fraction of cross linked water insoluble sodium hyaluronate and water soluble sodium hyaluronate polymers. This polymer consists of repeating disaccharide units of N-acetyl-glucosamine and sodium gluconate linked by β 1-3 and β 1-4 glycosidic bonds. The hydration fluid is isotonic sodium chloride solution (pH 7.2).
Sodium hyaluronate is the physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and man. For example, it is present in the vitreous and aqueous humor of the eye, the synovial fluid, the skin and the umbilical cord. Sodium hyaluronate derived from various human or animal tissues does not differ chemically.
HYORTH XL is indicated for the treatment of pain in osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy, and to simple analgesics, e.g., paracetamol.
A single injection of HYORTH XL is administered by intra-articular route.
Strict aseptic administration technique must be followed. Inject subcutaneous lidocaine or similar local anesthetic prior to injection of HYORTH XL.
Aspirate joint effusion before injection of HYORTH XL. Do not use the same syringe for removing joint effusion and for injection of HYORTH XL.
Take care to remove the tip cap of the syringe and needle aseptically. Inject HYORTH XL into the joint through a 19 gauge needle.
The syringe is intended for single use. The contents of the syringe must be used immediately once the container is opened. Before injection, the air bubble is removed from the injection.
Inject the full 6 mL in one knee only. If treatment is bilateral, a separate syringe should be used for each knee.
HYORTH XL is contraindicated in patients with known history of hypersensitivity (allergy) to sodium hyaluronate (hyaluronan) preparations.
HYORTH XL is contraindicated in patients with knee joint infections or skin diseases in the area of injection site.
Do not concomitantly use disinfectants containing quaternary ammonium compounds for skin preparations because sodium hyaluronate is precipitated in their presence.
Do not inject HYORTH XL extra-articularly or into the synovial tissues and articular capsules. This will generally result in local and systemic adverse events.
Intavascular injections of HYORTH XL may lead to systemic adverse events.
General: The effectiveness and safety of the use of HYORTH XL in joints other than knee have not been established.
The safety and effectiveness of the use of HYORTH XL 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 HYORTH XL in severely inflamed knee joints have not been established.
The pre-filled syringe is intended for single use. Use the contents of the syringe immediately after its packaging is opened. Discard any unused HYORTH XL.
Opened or damaged packages of HYORTH XL should not be used. Always store in the original packaging (protected from light) at 30°C. DO NOT FREEZE.
Aspirate synovial effusion, if present, before each HYORTH XL injection.
HYORTH XL should be used with caution when there is evidence of lymphatic or venous stasis in that leg.
HYORTH XL should be used with caution in diabetic patients and patients with chronic disorders.
Information for Patients: Transient pain, and/or swelling of the joint may occur after intra-articular injection of HYORTH XL.
In some cases 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 patient should consult the attending physician regarding the appropriate time to resume such activities.
If the patient needs to repeat the dose, the second injection of HYORTH XL should be administered at least after 6 months.
Use in Specific Populations: Pregnant women, Nursing mothers and Pediatric age group: The safety and effectiveness of HYORTH XL have not been established in pregnant women, lactating mothers and children.
Pregnant women & Nursing mothers: The safety and effectiveness of HYORTH XL have not been established in pregnant women and lactating mothers.
Intra-articular injection may lead to local side effects like pain, heat sensation, reddening and swelling at the treated joint.
Placing an ice pack on the treated joint for 5 to 10 minutes would reduce the occurrence of such side effects.
Store below 30°C. Do not freeze. Protect from light.
Shelf-Life: When properly stored, HYORTH XL is stable for up to 36 months from the date of manufacture.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj 8 mg/mL (pre-filled syringe) x 1's.