protein C concentrate, human 500 unit intravenous solution

Generic name:
Protein c concentrate (human) - injection

Brand name(s)
Ceprotin

Protein C is a natural substance in your body that helps to decrease clotting in the blood vessels. This medication is used to prevent and treat blood clots (such as venous thrombosis, purpura fulminans) in people who are born with a severe lack of protein C.

Read the Patient Information Leaflet if available from your pharmacist before you start using protein C concentrate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor. The dosage is based on your medical condition, age, weight, lab tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition lasts or gets worse.

Lightheadedness may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy or unusual bruising/bleeding
• signs of infection (such as fever, chills)
• signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, severe stomach/abdominal pain)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• chest pain
• shortness of breath
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using protein C concentrate, tell your doctor or pharmacist if you are allergic to it; or to heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• low platelet counts after heparin treatment

This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as heart failure, high blood pressure).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (including virus infections such as hepatitis). Consult your doctor or pharmacist for more information, and ask whether you should get vaccinations before receiving this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• anti-platelet medications (including clopidogrel, NSAIDs such as aspirin/ibuprofen)
• "blood thinners" (such as enoxaparin, heparin, warfarin)
• clot-dissolving drugs (including thrombolytics such as alteplase)

If your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as protein C activity/levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.