Monoclate-P is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A. Human this medicine works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Human Monoclate-P is used to treat or prevent bleeding episodes in people with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia.

Human Monoclate-P is not for use in people with von Willebrand disease.

Human Monoclate-P may also be used for purposes not listed in this medication guide.

You should not use Monoclate-P if you have ever had a severe allergic reaction to Monoclate-P in the past.

Your body may develop antibodies to Monoclate-P, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Carefully follow all instructions about how to store this medicine. Each brand of human Monoclate-P may have specific instructions about keeping the medicine in a refrigerator or at room temperature, and for only a certain number of months.

Follow all directions on your prescription label. Do not use Monoclate-P in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Human Monoclate-P is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Human Monoclate-P is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing the medicine and diluent, keep the mixture at room temperature and use it within 3 hours. Do not put mixed medicine into a refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. A single-use vial is for one use only. After measuring your dose, throw this vial away, even if there is medicine left in it.

Do not use human Monoclate-P if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You may need to check your pulse before and during your injection. If your pulse becomes rapid, slow down or stop the injection until your pulse rate returns to normal.

While using human Monoclate-P, you may need frequent blood tests.

Your body may develop antibodies to Monoclate-P, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Carefully follow all instructions about how to store this medicine. Each brand of human Monoclate-P may have specific storage instructions.

Store the medicine and the diluent in their original container in the refrigerator. Do not freeze. Before preparing your dose, take these items of the refrigerator and allow them to reach room temperature.

You may also store the medicine and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.

If you store this medicine at room temperature, do not return it to the refrigerator.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

You should not use this medicine if you have ever had a severe allergic reaction to Monoclate-P, or if you are allergic to mouse proteins.

Before using human Monoclate-P, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human this medicine will not treat von Willebrand disease.

Your doctor may want you to receive a hepatitis vaccination before you start using human Monoclate-P.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether human antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Some brands of human Monoclate-P are not approved for use by anyone younger than 18 years old. Ask your pharmacist if you have any questions about the specific brands of this medicine.

Human Monoclate-P is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Human Monoclate-P is sometimes used only as needed, so you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, wheezing, difficult breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Human Monoclate-P may cause serious side effects. Stop using human Monoclate-P and call your doctor at once if you have:

• tingly feeling in your face, ears, or arms;

• headache, blurred vision, feeling jittery;

• fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or

• nausea, vomiting, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Monoclate-P may include:

• swelling, stinging, or irritation where the injection was given;

• chills;

• mild nausea; or

• allergic reaction.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with human antihemophilic factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.