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|Palivizumab

Palivizumab

Palivizumab is used for:

Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Palivizumab is a monoclonal antibody. It works by preventing RSV from reproducing.

Do NOT use Palivizumab if:

• you are allergic to any ingredient in Palivizumab

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

Before using Palivizumab :

Some medical conditions may interact with Palivizumab . 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 have a bleeding or blood clotting disorder, or low blood platelet levels
• if you are having heart surgery (cardiopulmonary bypass)

Some MEDICINES MAY INTERACT with Palivizumab . However, no specific interactions with Palivizumab are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Palivizumab 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 Palivizumab :

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

• Palivizumab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Palivizumab at home, carefully follow the injection procedures taught to you by your health care provider.
• If Palivizumab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• To best prevent infections, continue using Palivizumab for the full course of treatment even if you feel well.
• 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 Palivizumab , contact your doctor immediately.

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

Important safety information:

• Children, including those who develop RSV, should continue to receive monthly doses of this medicine throughout the RSV season (generally November through April in the Northern Hemisphere). The first dose should be given before the RSV season begins.
• PREGNANCY and BREAST-FEEDING: Palivizumab is not for use in women of child bearing age.

Possible side effects of Palivizumab :

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:

Cough; diarrhea; runny or stuffy nose; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue lips or skin; ear pain; fever; irregular heartbeat; pain, redness, or swelling at the injection site; stomach pain; wheezing.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Palivizumab is usually handled and stored by a health care provider. If you are using Palivizumab at home, store Palivizumab as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Palivizumab , please talk with your doctor, pharmacist, or other health care provider.
• Palivizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Palivizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.