Prothrombin complex is used to quickly reverse the effects of a blood-thinning medicine (such as warfarin) during a major bleeding episode, or when there is a need for emergency surgery or invasive medical procedure.

Prothrombin complex may also be used for purposes not listed in this medication guide.

You should not be treated with this medicine if you have:

• low levels of platelets in your blood after using heparin;
• excessive blood-clotting caused by a condition called disseminated intravascular coagulation; or
• a history of severe allergic reaction to prothrombin complex, Protein C or Protein S, Antithrombin III, heparin, human albumin, or Factors II, VII, IX, X.

If possible before you receive prothrombin complex, tell your caregivers if you have ever had:

• a stroke, including TIA (transient ischemic attack) or "mini-stroke";
• a heart attack;
• disseminated intravascular coagulation;
• severe circulation problems;
• chest pain (angina); or
• if you have had a blood-clot within the last 3 months.

Tell your doctor if you are pregnant or breastfeeding.

Prothrombin complex is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Use Prothrombin Complex (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;
• chest pain or pressure, pain when you breathe, shortness of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot deep in the body--swelling or pain in your arms, legs, or stomach.

Common side effects may include:

• low blood pressure;
• anemia;
• nausea, vomiting; or
• headache.

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.

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