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|Humate-P

Humate-P

Humate-P is used for:

Preventing and controlling bleeding in adult patients with hemophilia A. It is also used to control certain types of bleeding episodes in patients with mild to moderate or severe von Willebrand disease.

Humate-P is a human clotting factor complex prepared from pooled human plasma. It works by increasing the amount of clotting factor VIII and von Willebrand factor in the blood. This helps the blood to clot properly, which helps to stop bleeding.

Do NOT use Humate-P if:

• you are allergic to any ingredient in Humate-P
• you have had a severe allergic reaction to other medicines that contain antihemophilic factor or von Willebrand factor

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

Before using Humate-P :

Some medical conditions may interact with Humate-P . 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 history of blood clots in the legs, lungs, or eye or if you are at risk for developing blood clots

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

Ask your health care provider if Humate-P 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 Humate-P :

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

• Humate-P may be given as an injection at your doctor"s office, hospital, or clinic. If you will be using Humate-P at home, a health care provider will teach you how to use it. Be sure you understand how to use Humate-P . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do NOT shake Humate-P .
• Do not use Humate-P if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Humate-P , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Humate-P .

Important safety information:

• Humate-P comes from human blood. Rarely, patients receiving products that come from human blood have developed certain viral infections (eg, parovirus B19, hepatitis A). Discuss any questions or concerns with your doctor. Contact your doctor if you develop symptoms, such as fever, rash, joint aches or pain, loss of appetite, nausea, vomiting, unusual tiredness, or yellowing of the eyes or skin.
• Discuss with your doctor whether you should receive a hepatitis A and hepatitis B vaccine.
• Patients receiving products that come from human blood have a very rare risk of developing a central nervous system disease called Creutzfeldt-Jakob disease. Discuss any questions or concerns with your doctor.
• Tell your doctor or dentist that you take Humate-P before you receive any medical or dental care, emergency care, or surgery. Blood clotting tests will be performed if you have surgery.
• Lab tests, including blood clotting tests, blood hematocrit levels, factor VIII levels, or von Willebrand factor levels, may be performed while you use Humate-P . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Humate-P should be used with extreme caution in NEWBORNS; safety and effectiveness in newborns have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Humate-P can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Humate-P while you are pregnant. It is not known if Humate-P is found in breast milk. If you are or will be breast-feeding while you use Humate-P , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Humate-P :

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:

Mild numbness or tingling.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or stomach pain; calf pain, swelling, or tenderness; chest pain; dark urine; fever or chills; new or worsening bruising or bleeding; shortness of breath; yellowing of the skin or eyes.

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.

Store Humate-P in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Humate-P may be stored at room temperature, below 86 degrees F (30 degrees C), for up to 6 months. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Humate-P out of the reach of children and away from pets.

General information:

• If you have any questions about Humate-P , please talk with your doctor, pharmacist, or other health care provider.
• Humate-P 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 Humate-P . 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.