This product is used for the treatment of pain in osteoarthritis of the knee in patients who have failed to get adequate relief from simple painkillers or from exercise and physical therapy. Supartz is a solution consisting of highly purified sodium hyaluronate (hyaluronan). Hyaluronan is a natural substance found in the body and is a common constituent of connective tissues and the thick, viscous fluid (synovial fluid) found in joints. Hyaluronan acts like a lubricant and shock absorber in synovial fluid of a healthy joint. Osteoarthritis reduces your synovial fluid's ability to protect and lubricate your joint.

Uses:

Artzal is administered by an injection once a week into your knee for a total of five injections. Your doctor may recommend a local anesthetic prior to injection to minimize the possible discomfort associated with an injection. The cycle consists of 5 separate injections; the effectiveness of a single treatment cycle of less than five injections has not been established.

Precautions:

Immediately after you have the injection and for the next 48 hours, you may need to avoid activities such as jogging, tennis, heavy lifting or standing for a long time. Please note that no treatment, including Supartz helps in every single patient.

Do NOT use Supartz if:

· you are allergic to any ingredient in Supartz

· you have an infection or skin disease near the joint or injection site

Contact your doctor or health care provider right away if any of these apply to you.

Before using Supartz:

Some medical conditions may interact with Supartz. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

· if you are pregnant, planning to become pregnant, or are breast-feeding

· if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

· if you have allergies to medicines, foods, or other substances

· if you are allergic to birds or bird products (eg, eggs, feathers, poultry)

Some MEDICINES MAY INTERACT with Supartz. Tell your health care provider if you are taking any other medicines, especially any of the following:

· Quaternary ammonium salts because side effects may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Supartz may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Supartz:

UseArtzal as directed by your doctor. Check the label on the medicine for exact dosing instructions.

· Artzal comes with an additional patient leaflet. Read it carefully and reread it each time you get Supartz refilled.

· Artzal is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Artzal at home, carefully follow the injection procedures taught to you by your health care provider.

· Artzal is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections.

· If Artzal contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

· Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur.

· Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

· If you miss a dose of Supartz, contact your doctor to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Supartz.

Important safety information about Artzal:

· Supartz may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Supartz. Using Supartz alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

· You may experience a temporary inflammation in your knee after using Supartz. If the inflammation is severe or continues, contact your doctor.

· Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Supartz.

· Use Supartz with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

· PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Supartz, discuss with your doctor the benefits and risks of using Supartz during pregnancy. It is unknown if Supartz is excreted in breast milk. If you are or will be breast-feeding while you are using Supartz, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Supartz:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

Proper storage of Supartz:

Supartz is usually handled and stored by a health care provider. If you are using Supartz at home, store this medicine as directed by your pharmacist or health care provider. Keep Supartz out of the reach of children and away from pets.

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