The name of your medicine is Ceprotin, pronounced "see PRO ten".

Ceprotin contains Protein C, a natural protein that is made in the liver and is present in your blood. Protein C is a part of human plasma that regulates the blood clotting (coagulation) system and prevents abnormal clot formation (thrombosis). Plasma is the liquid part of human blood.

Ceprotin is used to treat patients with Severe Congenital Protein C Deficiency for the prevention and treatment of:

• venous thrombosis (blood clot in the vein), and
• purpura fulminans (blood spots, bruising and discoloring to skin as a result of clotting of small blood vessels in the skin).

The most serious and common adverse reactions observed in clinical trials were rash, itching and lightheadedness.

The following adverse reactions have been identified during postapproval use of Ceprotin: hemothorax, hypotension, hyperhydrosis, fever and restlessness.

Patients on low sodium/renal impairment diet should be informed that the quantity of sodium in the maximum daily dose of Ceprotin exceeds 200mg.

Ceprotin contains trace amounts of heparin, which may lead to Heparin- induced Thrombocytopenia.

As with all plasma-derived therapeutics, the potential to transmit infectious agents (e.g. viruses) cannot be totally eliminated.

Source: Baxter International Inc.

Ceprotin is given by intravenous administration (infusion into a vein). It is given to you under the close supervision of your doctor who is experienced in replacement therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible. Your dosage will vary depending upon your condition, your age and your body weight. Your doctor may require that you have blood taken to help determine the dose of Ceprotin that you should get. See following Instructions for Use.

BLUE COLOR BAR: Approximate dosage strength of 500 IU per vial.
GREEN COLOR BAR: Approximate dosage strength of 1000 IU per vial.

You should not use Ceprotin unless your doctor confirms that you have severe congenital Protein C deficiency.

You should tell your doctor about all your medical conditions.

Allergic to Mouse Protein or Heparin:
If you are known to have allergic-type reactions (rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and low blood pressure) to mouse protein or to heparin, you should talk to your doctor before using this product. Ceprotin contains small amounts of heparin and/or mouse protein as a result of the manufacturing process. If such a reaction occurs, you should discuss this with your doctor and your doctor will decide the right treatment.

Low Sodium Diet/Kidney Impairment:
You should talk with your doctor before using Ceprotin if you are on a low sodium diet or have problems with your kidney, as the amount of sodium in the maximum daily dose of Ceprotin exceeds 200 mg.

Pregnancy or Breast-feeding:
You should inform your doctor if you are pregnant or breast-feeding. Your doctor will decide if Ceprotin may be used during pregnancy and/or breast-feeding.

Tell your doctor about all the medicines you are taking including prescription and nonprescription medicines, vitamins, and herbal supplements. You should also tell your doctor if you are on a special diet.

Warnings

You could have an allergic reaction to Ceprotin. You should be aware of the early signs of allergic reactions. These include: rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and low blood pressure. The signs and symptoms of low blood pressure can include a weak pulse, feeling lightheaded or dizzy when you stand, and possibly shortness of breath. If you experience any of these symptoms while being treated with Ceprotin, quickly stop the treatment and contact your doctor. If you experience a severe allergic reaction, including difficulty breathing and (near) fainting, you should quickly seek emergency treatment.

You could get an infectious disease since this drug product is made from human plasma. However, there are steps in the collection of the plasma and in the making of Ceprotin to lessen this possibility. For example, blood and plasma donors are screened for certain viral infections. There are also steps in the processing of the plasma that can inactivate or remove viruses.

You could get an infection with a virus called Human Parvovirus B19 (B19 Virus). Fetuses are at risk to the B19 Virus. Symptoms of B19 Virus infection include fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Pregnant women should discuss this risk with their doctor.

Although, there are steps during the making of Ceprotin to reduce the risk of getting Hepatitis A and B, your doctor may recommend that you be vaccinated against these viruses.

Like all medicines, Ceprotin can cause side effects, although not everyone gets them.

The most serious and common side effects to Ceprotin observed in clinical trials were allergic reactions (rash and itching) and lightheadedness.

There have also been individual reports, after the drug was marketed, of thoracic hematoma (bleeding into the chest), hypotension (very low blood pressure), fever, restlessness and increased sweating.

You could develop antibodies that can prevent Ceprotin from working properly and therefore reduce its effect. This has not been seen in clinical studies.

If you develop any side effects, including any not listed in this leaflet, please contact your doctor.