When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to prothrombin complex or similar products that affect how your blood clots (such as heparin, protein C, antithrombin III, or albumin). You should not receive this medicine if you have a blood clotting disorder or thrombocytopenia caused by heparin.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of congestive heart failure.
• Make sure your doctor knows if you have had a stroke, heart attack, deep vein thrombosis (DVT), or any other heart or blood clot problem in the last 3 months. This medicine may increase your risk of blood clots. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, trouble breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness.
• This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you are concerned about this risk.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fast or uneven heartbeat
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Severe nausea and vomiting
• Sudden or severe headache, problems with vision, speech, or walking
• Warmth or redness in your face, neck, arms, or upper chest

If you notice these less serious side effects, talk with your doctor:

• Joint or muscle pain
• Mild headache
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088