Ceprotin 500 IU powder and solvent for solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
CEPROTIN 500UI powder and solvent for solution for injection.
Human Protein C
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What CEPROTIN is and what it is used for
- What you need to know before using CEPROTIN
- How to use CEPROTIN
- Possible adverse effects
- How to store CEPROTIN
- Contents of the pack and other information
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 produced in the liver and present in your blood. Protein C plays an important role in preventing excessive blood clotting and is therefore used to prevent and/or treat intravascular thrombosis.
CEPROTIN is used for the treatment and prevention of thrombotic and hemorrhagic lesions (called purpura fulminans) in patients with severe congenital protein C deficiency. Additionally, CEPROTIN may be used to treat a rare complication of a blood clot-preventing medication (anticoagulant medication called coumarin) which can lead to severe skin lesions (necrosis).
Furthermore, CEPROTIN is used to prevent thrombosis in patients with severe congenital protein C deficiency when one or more of the following situations occur:
- surgery or invasive therapy is imminent
- during initiation of coumarin therapy (anticoagulant medication)
- when coumarin therapy is insufficient
- when coumarin therapy is not possible
2. What you need to know before using CEPROTIN
Do not use CEPROTIN
- if you are allergic to human Protein C or to 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 will decide whether treatment with CEPROTIN should be continued or not.
Warnings and precautions
Talk to your doctor before starting to use CEPROTIN. Be especially careful with CEPROTIN if symptoms of allergy occur. Allergic symptoms include rash, urticaria, difficulty breathing, drop in blood pressure, chest tightness, and shock. If such symptoms occur during administration of CEPROTIN, the infusion must be stopped. These symptoms may represent an allergic reaction to any of the components, mouse protein, or heparin. The medicine may contain trace amounts of heparin and/or mouse protein as a result of the manufacturing process. If such reactions occur, your doctor will decide on the most appropriate treatment.
When medicines are prepared from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to exclude those at risk of carrying infections, and testing of individual donations and plasma pools for signs of viral/infections. Manufacturers of these medicines also include steps in the processing of blood or plasma that can inactivate or remove viruses. Despite this, when medicines prepared from human blood or plasma are administered, it is not possible to completely rule out the transmission of infectious diseases. This also applies to unknown or emerging viruses and other potential types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), and against non-enveloped viruses such as hepatitis A. The measures taken may not be sufficient against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be severe in pregnant women (fetal infection) and in individuals with weakened immune systems or with certain types of anemia (e.g. hemolytic anemia).
Your doctor may recommend appropriate vaccination against hepatitis A and B if you frequently receive plasma-derived factor VIII.
Use of CEPROTIN with other medicines
Currently, no interactions with other medicines are known.
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
If switching from oral anticoagulant therapy, treatment with CEPROTIN should continue until the blood level of the oral anticoagulant medicine is adequate and stable.
Use of 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether CEPROTIN can be used during pregnancy or breast-feeding.
Driving and using machines
CEPROTIN has no influence on the ability to drive or use machines.
Important information about some ingredients of CEPROTIN
Since the amount of sodium in the maximum daily dose may exceed 200 mg, it may be harmful for individuals on a low-sodium diet.
3. How to use CEPROTIN
CEPROTIN is intended for intravenous administration (infusion into a vein). It will be administered under the close supervision of a physician experienced in coagulation factor/inhibitor replacement therapy, where monitoring of protein C activity is possible. The dosage will vary depending on your condition and body weight.
Dosage
The dose, frequency of administration, and duration of treatment depend on the severity of protein C deficiency as well as your clinical status and plasma levels of protein C. These should be adjusted based on clinical efficacy and laboratory results.
Initially, a protein C activity of 100% should be achieved, and activity should be maintained above 25% throughout the duration of treatment.
An initial dose of 60 to 80 IU/kg should be administered. Your doctor will take several blood samples to determine how long protein C remains in your body.
Measurement of protein C activity using chromogenic substrates is recommended to determine your plasma protein C levels before and during treatment with CEPROTIN.
The dose should be determined based on laboratory-measured protein C activity. In the case of an acute thrombotic event, measurements should be performed every 6 hours until the patient is stabilized, then twice daily, and always immediately prior to the next infusion. Note that the half-life of protein C may be significantly shortened in certain clinical conditions such as acute thrombosis with purpura fulminans and skin necrosis.
If you have liver or kidney disease, please inform your doctor, as your treatment may need to be appropriately adjusted.
If you are switching to long-term oral anticoagulant therapy, protein C replacement should only be discontinued once stable anticoagulation has been achieved (see "Important information about some of the components of CEPROTIN").
If you are receiving prophylactic protein C administration, higher trough levels may be required in situations associated with an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Your doctor may appropriately adjust your treatment if you have resistance to activated protein C (APC), which is a thromboembolic risk factor present in up to 5% of the European population.
Administration
CEPROTIN will be administered to you by intravenous injection after reconstituting the lyophilized powder for injectable solution with sterile water for injections. It is strongly recommended to record the name and batch number of the product each time you receive a dose of CEPROTIN to maintain a record of the batches used.
Reconstitute the lyophilized powder of CEPROTIN for injectable solution with the supplied solvent (sterile water for injections) using the sterile transfer needle. Gently rotate the vial until all the powder is dissolved.
After reconstitution, withdraw the solution using a sterile filter needle and transfer it into a sterile disposable syringe. A new sterile filter needle must be used for each reconstituted CEPROTIN vial. The solution should be discarded if visible particles are present.
The reconstituted solution should be administered immediately by intravenous injection.
CEPROTIN should be administered at a maximum infusion rate of 2 ml per minute. In children with body weight below 10 kg, the infusion rate should not exceed 0.2 ml/kg/min.
Unused solution, empty vials, and used needles and syringes must be properly disposed of.
The frequency and duration of treatment depend on the severity of your protein C deficiency, the results of plasma protein C level determinations, and the location and extent of thrombosis.
In cases of acute thrombosis, CEPROTIN may be administered every 6 hours. As the tendency to form clots decreases, the frequency may be reduced.
If you use more CEPROTIN than you should
It is recommended to follow the dose level and administration frequency prescribed by your doctor. If you receive more CEPROTIN than recommended, 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 about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You may notice any of the following adverse effects after administration of CEPROTIN:
- As with any medicine administered by intravenous infusion, allergic reactions including severe and life-threatening reactions (anaphylaxis) may occur (although they have not been observed with CEPROTIN). In any case, you should be aware of the initial signs of allergic reactions such as burning and itching at the injection site, chills, flushing, rash, urticaria, difficulty breathing, nausea, headache, drowsiness, drop in blood pressure, and chest tightness.
- The following adverse effects were observed very rarely during clinical trials (less than 1 case per 10,000 administrations given to patients): fever (pyrexia), increased C-reactive protein, inflamed skin lesions (urticaria), itching (pruritus), rash, and dizziness.
- In post-marketing experience, restlessness, bleeding in the chest, increased sweating, and pain and redness at the injection site have been observed.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of CEPROTIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep the container in the original outer packaging to protect it from light.
The reconstituted solution must be used immediately.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of CEPROTIN
Powder:
- The active substance is human Protein C.
- The other components are human albumin, sodium chloride, and sodium citrate·2H2O.
Solvent: Sterile water for injection.
Appearance of the product and contents of the pack
CEPROTIN is presented as a powder and solvent for injectable solution and appears as a white or almost white powder or solid which crumbles easily. After reconstitution, the solution is colorless to slightly yellowish, clear to slightly opalescent, and essentially free from visible particles.
Each pack also contains a transfer needle and a filter needle.
Marketing Authorization Holder and Manufacturer
BAXTER AG
Industriestrasse 67
A-1221 Vienna, Austria
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Baxalta Belgium SPRL Tel./Tel.: +32-2-386 80 00 | Lithuania UAB Baxter Lithuania Tel.: +370 5 269 16 90 |
Bulgaria Baxter Bulgaria EOOD Tel.: +359 2 9808482 | Luxembourg/Luxembourg Baxalta Belgium SPRL Tél./Tel.: +32-2-386 80 00 |
Czech Republic BAXTER CZECH spol. s r.o. Tel.: +420 225774111 | Hungary Baxter Hungary Kft Tel.: +36 1 202 1980 |
Denmark Baxalta Denmark A/S Tlf.: +45 4816 64 00 | Malta Baxalta UK Limited Tel.: +44 1635 206345 |
Germany Baxalta Deutschland GmbH Tel.: +49 89 31701 0 | Netherlands Baxalta Netherlands B.V. Tel.: +31-30-2488911 |
Estonia OÜ Baxter Estonia Tel.: +372 6 515 120 | Norway SHELFCO - Baxalta Norway AS Tlf.: +47-22 58 48 00 |
Greece Baxter Hellas ΕΠΕ Tel.: +30-210-28 80 000 | Austria Baxalta Österreich GmbH Tel.: +43 (0)1 71120-0 |
Spain Baxalta Spain S.L. Tel.: +34-96-2722800 | Poland Baxter Polska Sp. z o.o. Tel.: +48 22 4883 777 |
France Baxalta France SAS Tél.: +33-1-3461-5050 | Portugal Baxalta Portugal, Unipessoal, Lda. Tel.: +351 21-925 25 00 |
Croatia Baxter d.o.o. Tel.: +386 1 420 16 80 | Romania FARMACEUTICA REMEDIA SA Tel.: +40-21-321 16 40 |
Ireland Baxalta UK Limited Tel.: +353-1-2065500 | Slovenia Baxter d.o.o. Tel.: +386 1 420 16 80 |
Iceland Icepharma hf. Tel.: +354-540-8000 | Slovakia Baxter Slovakia, s.r.o. Tel.: +421 2 59418455 |
Italy Baxalta Italy S.r.l. Tel.: +39-06 32491-1 | Finland SHELFCO - Baxalta Finland Oy Tel.: +358-9-862-1111 |
Cyprus Baxter Hellas ΕΠΕ Tel.: +30-210-28 80 000 | Sweden Baxalta Sweden AB Tel.: +46-8-632 64 00 |
Latvia SIA Baxter Latvia Tel.: +371 67784784 | United Kingdom Baxalta UK Limited Tel.: +44 1635 206345 |
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.