"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Monoclate-P Patient Information including How Should I Take
In this Article
- What is human antihemophilic factor (Monoclate-P)?
- What are the possible side effects of human antihemophilic factor (Monoclate-P)?
- What is the most important information I should know about human antihemophilic factor (Monoclate-P)?
- What should I discuss with my health care provider before using human antihemophilic factor (Monoclate-P)?
- How should I use human antihemophilic factor (Monoclate-P)?
- What happens if I miss a dose (Monoclate-P)?
- What happens if I overdose (Monoclate-P)?
- What should I avoid while using human antihemophilic factor (Monoclate-P)?
- What other drugs will affect human antihemophilic factor (Monoclate-P)?
- Where can I get more information?
What should I discuss with my health care provider before using human antihemophilic factor (Monoclate-P)?
Do not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse proteins.
Before using human antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.
FDA pregnancy category C. It is not known whether antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether human antihemophilic factor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
This medicine 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.
Your doctor may want you to receive a hepatitis vaccination before you start using human antihemophilic factor.
How should I use human antihemophilic factor (Monoclate-P)?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.
Human antihemophilic factor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Always wash your hands before preparing and giving your injection.
Human antihemophilic factor must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.
Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.
After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.
Prepare your dose in a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.
Do not use this medicine if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
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.
Human antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication. For surgery, you may need to use the medicine for 10 to 14 days.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.
Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.
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.
Store the medication and the diluent in the refrigerator and do not allow them to freeze.
You may also store the medicine and diluent at room temperature until the expiration date on the label. Some brands of this medicine (such as Koate-DVI and Monoclate) may be stored at room temperature for up to 6 months. Follow the storage directions on the medicine label.
Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.
Additional Monoclate-P Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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