Ceprotin

human protein C

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is CEPROTIN?

CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection. It contains the active substance human protein C.

What is CEPROTIN used for?

Protein C is a natural substance in the blood that controls clotting. CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death). CEPROTIN is also used for the short-term prevention of clotting in patients with severe congenital protein C deficiency in certain situations when there is an increased risk of clotting, such as surgery or when treatment with a coumarin is not sufficient or possible.

The medicine can only be obtained with a prescription.

How is CEPROTIN used?

CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity. CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.

How does CEPROTIN work?

CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood). In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting. Protein C slows down the production of thrombin, and therefore slows down further clotting. An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.

How has CEPROTIN been studied?

CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency. The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation. Additionally, any improvement in skin lesions was monitored.

What benefit has CEPROTIN shown during the studies?

In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis. The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.

What is the risk associated with CEPROTIN?

Hypersensitivity (allergic reactions) has sometimes been seen. If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop. For the full list of all side effects reported with CEPROTIN, see the Package Leaflet.

CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.

When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.

Why has CEPROTIN been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN’s benefits are greater than its risks for patients with severe congenital protein C deficiency. The Committee recommended that CEPROTIN be given marketing authorisation.

CEPROTIN was originally authorised under ’Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease. As the company had supplied the additional information requested, the ’Exceptional Circumstances’ ended on 28 July 2006.

Other information about CEPROTIN

The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001. The marketing authorisation was renewed on 16 July 2006.

This EPAR was last updated on 30/11/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

27/10/2011  Ceprotin -EMEA/H/C/000334 -II/0064

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

CEPROTIN is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency. Furthermore CEPROTIN is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:

- surgery or invasive therapy is imminent

- while initiating coumarin therapy

- when coumarin therapy alone is not sufficient

- when coumarin therapy is not feasible.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents