Prothrombin Complex Concentrate (Human) for injection

What is this medicine?

PROTHROMBIN COMPLEX CONCENTRATE (proh THROM bin KUM pleks KON suhn treyt) is used in patients who are taking a vitamin K antagonist like warfarin to stop bleeding or when urgent surgery is needed.

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• confusion, trouble speaking or understanding

• cough or other signs of infection

• fever or chills

• severe headaches

• shortness of breath, chest pain, swelling in a leg

• sudden numbness or weakness of the face, arm or leg

• trouble walking, dizziness, loss of balance or coordination

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• nausea, vomiting

• trouble sleeping

What may interact with this medicine?

This medicine may interact with the following medications:

• factor VIIa

What if I miss a dose?

This does not apply.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease or recent heart attack

• history of disseminated intravascular coagulation

• history of heparin-induced thrombocytopenia

• history of stroke or transient ischemic attack

• peripheral vascular disease

• an unusual or allergic reaction to prothrombin complex concentrate, heparin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.