Ceprotin
human protein C
human protein C
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What CEPROTIN is and what it is used for
What you need to know before you use CEPROTIN
How to use CEPROTIN
Possible side effects
How to store CEPROTIN
Contents of the pack and other information
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.
if you are allergic to human protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin.
However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.
Talk to your doctor or pharmacist before using 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.
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.
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 (foetal 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.
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.
Not applicable.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.
CEPROTIN has no influence on your ability to drive or to operate machines.
This medicine contains 22.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.1% of the recommended maximum daily dietary intake of sodium for an adult.
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.
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).
IfyouhaveAPCresistancewhichisathromboembolicriskfactorpresentinupto5%ofthe populationinEuropeyourdoctormayneedtoadjustyourtreatmentaccordingly.
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.
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.
Not applicable.
Do not stop using CEPROTIN without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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.
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 rarely observed during clinical studies (less than 1 case in 1,000 administrations given to patients): itching (pruritus), rash and dizziness.
In the postmarketing experience there have been reports of restlessness, excessive sweating, and pain and redness at the injection site.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listedinAppendixV. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 (2C – 8C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
The reconstituted solution should be used immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Powder:
The active substance is human protein C
The other ingredients are human albumin, trisodium citrate dihydrate and sodium chloride. As solvent Sterilised Water for Injections is used.
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.
Takeda Manufacturing Austria AG Industriestrasse 67
1221 Vienna Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Takeda, UAB
Tel: +370 521 09 070
Такеда България ЕООД Тел.: +359 2 958 27 36
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722
Takeda Pharma Kft.
Tel: +36 1 270 7030
Takeda Pharma A/S Tlf: +45 46 77 10 10
Τakeda HELLAS SA Tel: +30 2106387800
Takeda GmbH
Tel: +49 (0)800 825 3325
Takeda Nederland B.V.
Tel: +31 20 203 5492
Takeda Pharma AS Tel: +372 6177 669
Takeda AS
Tlf: +47 800 800 30
Τakeda ΕΛΛΑΣ ΑΕ Tηλ: +30 210 6387800
Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 50
Takeda Farmacéutica España S.A Tel: +34 917 90 42 22
Takeda Pharma Sp. z o.o. tel: +48223062447
Takeda France SAS Tel. + 33 1 40 67 33 00
Takeda Farmacêuticos Portugal, Lda. Tel: + 351 21 120 1457
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
Takeda Products Ireland Ltd
Tel: 1800 937 970
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480
Vistor hf.
Sími: +354 535 7000
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
Takeda Italia S.p.A.
Tel: +39 06 502601
Takeda Oy
Puh/Tel: 0800 774 051
Τakeda ΕΛΛΑΣ ΑΕ Τηλ.: +30 2106387800
Takeda Pharma AB Tel: 020 795 079
Takeda Latvia SIA
Tel: +371 67840082
Takeda UK Ltd
Tel: +44 (0) 2830 640 902
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.