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.