Antihemophilic Factor VIII, Human Recombinant Residues 743-1636 Deleted Injection 1 unit (ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

Do not dilute the medicine until ready to use.

Always inspect the medicine before using.

The liquid should be clear and colorless.

Do not use the medicine if it contains any particles or if it has changed color.

Keep medicine in refrigerator. Do not freeze. Protect from light.

If needed, this medicine may be stored at room temperature for up to 3 months.

Do not store above 77 degrees F (25 degrees C).

Do not store in the bathroom.

If your medicine is stored in the refrigerator, take it out of the refrigerator before use to warm to room temperature.

Inject the medicine immediately after mixing.

Injecting cold drug may be uncomfortable.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Discard any unused, mixed medicine after 3 hours.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

You or a family member can be trained to give this medicine at home.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Brand Name(s): Xyntha

Generic Name: Antihemophilic Factor VIII, Human Recombinant Residues 743-1636 Deleted

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Call your doctor right away if you notice any unusual bleeding or bruising.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • feeling of heat or flushing
  • fever or chills
  • headaches
  • pain, redness, swelling near injection
  • nausea
  • rapid heartbeat

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • chest pain
  • shortness of breath

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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