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|Hyaluronate Sodium Derivative

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HYALURONATE SODIUM DERIVATIVE (Systemic)

Some commonly used brand names are:

In the U.S.—

Synvisc

Another commonly used name is hylan G-F 20 .

Description

Hyaluronate (hye-a-loo-ROE-nate) sodium derivative is similar to a substance that occurs naturally in joints that helps joints work properly by acting like a lubricant and shock absorber. This medicine is injected into the knee to relieve pain caused by osteoarthritis.

This medicine is to be administered only by or under the immediate supervision of your doctor. It is available only with your doctor"s prescription, in the following dosage form(s):

Parenteral
Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hyaluronate sodium derivative, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to hyaluronate sodium derivative, other hylans, hyaluronate sodium, bird protein, feathers, or egg products. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women.

Breast-feeding—It is not known whether hyaluronate sodium derivative passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of hyaluronate sodium derivative in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hyaluronate sodium derivative in the elderly with use in other age groups.

Other medical problems—The presence of other medical problems may affect the use of hyaluronate sodium derivative. Make sure you tell your doctor if you have any other medical problems, especially:

Skin or knee joint infections or other problems at the place where the injection is to be given—This medicine should not be injected there

Proper Use of This Medicine

Dosing—The dose of hyaluronate sodium derivative will be different for different patients. The following information includes only the average doses of hyaluronate sodium derivative.

For parenteral dosage form (injection):
- For knee pain caused by osteoarthritis:
  - Adults—By injection into the knee, 16 milligrams (mg) once a week (one week apart) for a total of three injections.
  - Children—Use and dose must be determined by your doctor.

Precautions While Using This Medicine

For the first 48 hours after you receive this medicine, avoid strenuous activities or prolonged (more than 1 hour) activities that put a lot of weight on your legs, such as jogging, heavy lifting, playing tennis, or standing on your feet for a long period of time.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Difficulty breathing; hives; shortness of breath

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Knee pain; pain at the injection site; swelling of the knee

Rare

Calf cramps; dizziness; facial flushing with swelling of the lips; headache; infection of the joint; itching of the skin; muscle pain; nausea; pain on one side of the body with anxiety, nausea, and tiredness; rapid heartbeat; skin rash

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 10/15/1998

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