What is it and how is it used?

CEPROTIN belongs to a class of medicines called antithrombotics. This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood. Protein C plays a major role in prevention of excessive clot formation thus, prevent and/or treat intravascular thrombosis.

CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency. Additionally, CEPROTIN may be used to treat a rare complication of a blood thinner medication (anticoagulant medication named coumarin) which may result in severe skin lesion (necrosis).

Furthermore CEPROTIN is used to prevent thrombosis 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 (anticoagulant medication, blood thinner) therapy
  • when coumarin therapy alone is not sufficient
  • when coumarin therapy is not feasible.
Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use CEPROTIN,

  • if you are allergic (hypersensitive) to Human Protein C or any of the other ingredients of CEPROTIN including mouse protein or heparin.

However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.

Take special care with CEPROTIN,

if symptoms of allergy occur. Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock. If such symptoms occur during the administration of CEPROTIN, injection should be stopped. Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin. The preparation may contain traces of heparin and/or mouse protein as a result of the manufacturing process. If such a reaction occurs, your doctor will decide on the most appropriate treatment.

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B 19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived Protein C products.

Taking other medicines

No interactions with other medicinal products are currently known.
Nevertheless, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you change to treatment with oral anticoagulants, treatment with CEPROTIN must continue until the blood level of the oral anticoagulation is adequate and stable.

Using CEPROTIN with food and drink

Not applicable.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or breast-feeding. Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.

Driving and using machines

CEPROTIN has no influence on your ability to drive or to operate machines.

Important information about some of the ingredients of CEPROTIN

As the quantity of sodium in the maximum daily dose may exceed 200 mg, this should be taken into consideration by patients on a controlled sodium diet.

How is it used?

CEPROTIN is intended for intravenous administration (infusion into a vein). It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible. Dosage will vary depending on your condition and your body weight.

Dosage

The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C. They should be adjusted accordingly on the basis of clinical effectiveness and laboratory assessment.

A protein C activity of 100 % should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment.
An initial dose of 60 to 80 IU/kg should be administered. Your physician will take several blood drawings over time to determine how long protein C is remaining in your body.
The measurement of protein C activity using chromogenic substrates is recommended for the determination of your plasma level for protein C before and during treatment with CEPROTIN.

The dosage should be determined on the basis of laboratory measurements of the protein C activity. In the case of an acute thrombotic event these should be performed every 6 hours until your condition is stabilised, thereafter twice a day and always immediately before the next injection. It should be kept in mind that the half-life of protein C may be severely shortened in certain clinical conditions such as acute thrombosis with purpura fulminans and skin necrosis.

If you have kidney and/or liver disease, please inform your doctor, because he may have to adjust your treatment accordingly.

If you are switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see ?Important information about some of the ingredients of CEPROTIN?).

If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).

If you have APC resistance which is a thromboembolic risk factor present in up to 5 % of the

population in Europe your doctor may need to adjust your treatment accordingly.

Administration

CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections. It is strongly recommended that every time you receive a dose of CEPROTIN the name and batch number of the product are recorded in order to maintain a record of the batches used.

Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle. Gently rotate the vial until all powder is dissolved.

After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe. A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN. The solution should be discarded if particulate matter is visible.

The reconstituted solution should be administered immediately by intravenous injection.

CEPROTIN should be administered at a maximum injection rate of 2 ml per minute. In children with a body weight of less than 10 kg, the injection rate should not exceed a rate of 0.2 ml/kg/min.

All unused solution, empty vials and used needles and syringes must be discarded appropriately.

Frequency and duration of treatment depend on the severity of your protein C deficiency, on the results of determination of protein C levels in your plasma as well as on the location and extent of thrombosis.

In case of acute thrombosis CEPROTIN may be administered to you every 6 hours. As the tendency for thrombus formation decreases, the frequency may be reduced.

If you use more CEPROTIN than you should

It is recommended that you adhere to the dose level and frequency of administration as recommended by your doctor. In case you administered more CEPROTIN than recommended, please inform your doctor as soon as possible.

If you forgot to take CEPROTIN

Not applicable.

If you stop using CEPROTIN

Do not stop using CEPROTIN without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, CEPROTIN can cause side effects, although not everybody gets them.

You may notice any of the following side effects after administration of CEPROTIN:

  • As with any product administered by infusion into a vein allergic reactions including severe and potentially life-threatening reactions (anaphylaxis) are possible but have not been seen with CEPROTIN. Nevertheless you should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest.
  • The following side effects were very rarely observed during clinical studies (less than 1 case in 10 000 administrations given to patients): fever (pyrexia), increased C-reactive protein, wheals (urticaria), itching (pruritus), rash and dizziness.
  • In the postmarketing experience there have been reports of restlessness, bleeding into the chest, excessive sweating, increased body temperature, and increased need for catecholamines (medicine to elevate blood pressure) in the course of the treatment.

If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop that can inhibit protein C and therefore diminish the effect of the preparation. However, this has not been observed in the clinical studies to date.

If any of these side effects gets worse or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Do not use CEPROTIN after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C ? 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.

The reconstituted solution should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What CEPROTIN contains

Powder:

  • The active substance is human protein C- The other ingredients are human albumin, sodium chloride and sodium citrate.2H 2O. As solvent Sterilised Water for Injections is used.
What CEPROTIN looks like and contents of the pack

CEPROTIN is presented as powder and solvent for solution for injection and is a white or cream coloured powder or friable solid. After reconstitution the solution is colourless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles.

Each pack also contains one transfer needle and one filter needle.

Marketing Authorisation Holder and Manufacturer

BAXTER AG
Industriestrasse 67
A-1220 Vienna Austria

For any information about this medicine, please contact the local representative of BAXTER AG given below.

BelgiëBelgiqueBelgien Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BrusselBruxelles Brüssel Tél.Tel. 32-2-650-1711 LuxembourgLuxemburg Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BruxellesBrüssel, BelgiqueBelgium Tél.Tel. 32-2-650-1711

. 4 1000 . 359 2 9808482 Magyaroszág Baxter Hungary Kft Alkotás u. 53. D torony V.em. H-1123 Budapest Tel. 36 1 202 1980

eská republika Baxter Czech spol.s r.o. Opletalova 55 CZ-110 00 Praha 1 Tel. 420 225774111 Malta Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK United Kingdom Tel. 44 1635 206345

Danmark Baxter AS Gydevang 43 DK-3450 Allerød Tlf. 45-48-16 64 00 Nederland Baxter B.V. Kobaltweg 49 NL-3542 CE Utrecht Tel. 31-30-2488911

Deutschland Baxter Deutschland GmbH Im Breitspiel 13 D-69126 Heidelberg Tel. 49-6221-397-0 Norge Baxter AS Gjerdrumsvei 11 N-0486 Oslo Tlf. 47-22 58 48 00

Eesti AS Oriola Saku tn. 8 EE-11314 Tallinn Tel. 372 6 515 100 Österreich Baxter Vertriebs GmbH Landstraßer Hauptstraße 99 Top 2A A-1031 Wien Tel. 43-1-71120-0

Polska Baxter Poland Sp. z o.o. ul. Kruczkowskiego 8 PL-00-380 Warszawa Tel. 48 22 4883 777 Baxter Hellas 34 GR-16341 . 30-210-9987000

España Baxter S.L. Pouet de Camilo, 2 E-46394 Ribarroja del Turia Valencia Tel. 34-96-2722800 Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Ind. da Abrunheira, Edifício 10 P-2710-089 Sintra Tel. 351 21-925 25 00

France Baxter 6, Avenue Louis-Pasteur BP 56 F-78311 Maurepas Cedex Tél. 33-1-3461-5050 România FARMACEUTICA REMEDIA SA 42 Octavian St. sector 3 031232 Bucharest-RO Tel. 40-21-321 01 90

Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL-Blackrock, Dublin Tel. 353-1-2065500 Slovenija Baxter AG Podrunica Ljubljana elezna cesta 14 SI-1000 Lubljana Tel. 386 1 420 16 80

Ísland Icepharma hf., Lynghalsi 1 IS-110 Reykjavík Sími 354-540-8000 Slovenská republika Baxter AG, o. z. Dúbravská cesta 2 SK-841 04 Bratislava Tel. 421 2 59418455

Italia Baxter S.p.A. V.le Tiziano, 25 I-00196 Roma Tel. 39-06 32491-1 SuomiFinland Baxter Oy PL 270 Valimotie 15 A FIN-00381 Helsinki PuhTel. 358-9-862-1111

Sverige Baxter Medical AB Torshamnsgatan 35 S-164 40 Kista Tel. 46-8-632 64 00 Baxter Hellas 34 GR-16341 , . 30-210-9987000

Latvija SIA Oriola-Rga Dzelzavas iela 120 M LV-1021 Rga Tel. 371 7 802 450 United Kingdom Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel. 44 1635 206345

Lietuva

UAB TAMRO atstovyb-
S. -ukausko g. 29-1
LT-09129 Vilnius
Tel.: +370 5 269 16 91

This leaflet was last approved in

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