Patient leaflet - Ceprotin
1. What CEPROTIN is and what it is used for
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.
2. What you need to know before you use CEPROTIN
Do not use CEPROTIN
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– if you are allergic to human protein C or any of the other ingredients of this medicine (listed in
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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.
Warnings and precautions
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.
Other medicines and CEPROTIN
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.
CEPROTIN with food and drink
Not applicable.
Pregnancy and breast-feeding
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.
Driving and using machines
CEPROTIN has no influence on your ability to drive or to operate machines.
CEPROTIN contains Sodium
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.
3. How to use CEPROTIN
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 of2 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 forget to use 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
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.
Reporting of side effects
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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store CEPROTIN
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 (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.
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.
6. Contents of the pack and other information
What CEPROTIN contains
Powder:
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– The active substance is human protein C
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– The other ingredients are human albumin, trisodium citrate dihydrate and sodium chloride. As
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
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
Tel.: +800 66838470
E-mail:
This leaflet was last approved in.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.