500 IU powder and solvent for solution for injection.
human protein C
1. What CEPROTIN is and what it is used for
CEPROTIN belongs to a group of medicines called anticoagulants. This drug contains protein C, a natural protein that is formed in the liver and is found in the blood. Protein C plays an important role in preventing excessive clot formation in order to prevent and / or treat blood clots in the blood vessels.
CEPROTIN is used to treat and prevent skin damage caused by blood clots and bleeding (called purpura fulminans ) in patients with severe congenital protein C deficiency. CEPROTIN can also be used to treat a rare side effect of a blood thinner ( anticoagulant called vitamin K antagonist ), which can result in severe skin damage ( necrosis ).
CEPROTIN is also used to prevent blood clots in patients with severe congenital protein C deficiency if one or more of the following conditions are met:
- before imminent surgery or invasive surgery
- during initial treatment with vitamin K antagonist ( AVK ) ( anticoagulants, blood thinners)
- when AVK treatment alone is not enough
- when AVK treatment is not possible
2. What you need to know before using CEPROTIN
Do not use CEPROTIN
- if you are allergic (hypersensitive) to human protein C or any of the other ingredients of this medicine (listed in section 6), including mouse protein or heparin .
In case of life-threatening thrombotic complications, your doctor will decide if you should receive CEPROTIN or not.
Warnings and cautions
Talk to your doctor or pharmacist before using CEPROTIN. Take special care with CEPROTIN if allergic symptoms occur. Allergic symptoms include rash, difficulty breathing, low blood pressure, chest tightness, and shock. If these symptoms occur during administration of CEPROTIN, the injection should be discontinued. Such symptoms may indicate an allergic reaction to one of the ingredients, mouse protein or heparin . The drug may contain traces of heparin and/or mouse protein after the manufacturing process. If such a reaction occurs, your doctor will decide which treatment is appropriate.
If the preparation is used by patients with severe congenital protein C deficiency, antibodies to protein C may develop, thereby reducing the effect of the drug. However, this has not been observed so far in clinical studies.
When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes a careful selection of blood and plasma donors to ensure that those at risk of carrying an infection are excluded, and that each donation and plasma pool is tested for signs of virus / infection. The manufacturers of these products also include steps in the management of blood and plasma that can inactivate or secrete viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered to be effective against enveloped viruses such as HIV , hepatitis B and hepatitis C, and for the non-enveloped hepatitis A virus . The measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious in pregnant women ( fetal infection ) and in patients with immunodeficiency or certain types of anemia (eg sickle cell or haemolytic anemia ).
Your doctor may suggest hepatitis A and B vaccination if you are regularly / repeatedly treated with Protein C products extracted from human plasma.
Other medicines and CEPROTIN
No interactions with other drugs are currently known.
Despite this, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are switching to oral anticoagulants , treatment with CEPROTIN must be continued until the anticoagulant effect is stable.
CEPROTIN with food and drink
Not relevant.
Pregnancy and breastfeeding
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 should be used during pregnancy and breast-feeding.
Driving and using machines
CEPROTIN has no effect on your ability to drive or use machines.
CEPROTIN contains sodium
This medicine contains 22.5 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 1.1% of the highest recommended daily intake of sodium for adults.
3. How to use CEPROTIN
CEPROTIN is for intravenous administration ( infusion into a vein). It is given under the supervision of a doctor who has experience of treatment with coagulation factors/inhibitors where control of protein C activity is possible. Dosage one varies depending on your condition and your body weight.
Dosage
The dose, frequency of administration, and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and plasma levels of protein C. These factors should be adjusted based on the clinical effect and laboratory tests in the individual case.
A protein C activity of 100% should be obtained initially and the activity should be maintained above 25% during the course of treatment.
An initial dose of 60 to 80 IU / kg should be given. Your doctor will take several blood tests to determine how long protein C stays in your body. Measurement of protein C activity by chromogenic substrate method for determining your plasma protein C levels is recommended before and during treatment with CEPROTIN.
Dosage one should be based on the protein C activity determined in the laboratory. In the event of an acute thrombotic event, laboratory tests should be performed every 6 hours until your medical condition has stabilized, then twice daily and immediately before the next injection. It should be remembered that the half-life of protein C can be greatly shortened in certain clinical conditions such as acute thrombosis with fulminant purpura and skin necrosis.
If you have kidney and/or liver disease, tell your doctor as this may mean that treatment may need to be adjusted.
If you switch to prophylactic treatment with oral anticoagulants , the protein C substitution should not be discontinued until stable anticoagulation has been achieved (see “Important information about some of the ingredients of CEPROTIN”).
If you are treated prophylactically with protein C, higher minimum levels may be justified in situations where there is an increased risk of thrombosis (eg in case of infection , trauma or surgery).
If you are APC- resistant , which is a thromboembolic risk factor in up to 5% of the population in Europe, your doctor may need to adjust your treatment accordingly.
Administration
CEPROTIN is given by intravenous injection after reconstitution of the powder for solution for injection with sterile water for injections. When you are given CEPROTIN, it is recommended that the product name and batch number be registered to enable the tracking of the used product.
Dissolve lyophilised CEPROTIN powder for solution for injection in the supplied diluent (sterile water for injections) using the sterile transfer needle. Gently rotate the vial until all the 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 for each vial of dissolved CEPROTIN. The solution should be discarded if particles can be observed.
The reconstituted solution should be given immediately as an intravenous injection.
CEPROTIN should be given at a maximum injection rate of 2 ml/min. In children weighing less than 10 kg, the injection rate should not exceed 0.2 ml / kg / min.
The unused solution, empty vials, used needles, and syringes must be disposed of properly.
The frequency of treatment sessions and the duration of treatment depend on the severity of your protein C deficiency, on the results of the determinations of the protein C level in the plasma and on the location and extent of thrombosis .
In acute thrombosis, CEPROTIN can be given every 6 hours. As the tendency for thrombus formation decreases, the frequency may decrease.
If you use more CEPROTIN than you should
It is recommended that you adhere to the dose level and treatment intervals recommended by your doctor. If you take more CEPROTIN than you should, contact your doctor as soon as possible.
If you forget to use CEPROTIN
Not relevant.
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.
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 administering CEPROTIN:
- As with all products administered intravenously into a vein, allergic reactions, including severe and potentially life-threatening reactions ( anaphylaxis ) are possible.
You should be aware of early signs of allergic reactions such as burning and stinging sensation at the injection site, chills, redness, rash, difficulty breathing, nausea, headache, lethargy, low blood pressure, and chest tightness. - The following side effects are rarely observed during clinical studies (less than 1 case per 1000 administration’s patients): itching ( pruritus ), rash, and dizziness.
- Experience after the product has started to be marketed has given 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Keep the vial in the outer carton. Sensitive to 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is human protein C.
- The other ingredients are human albumin, trisodium citrate dihydrate, and sodium chloride. Sterile water for injections is used as the diluent .
What the medicine looks like and the contents of the pack
CEPROTIN is supplied as a powder and solvent for solution for injection. It is a white or off-white powder or brittle solid. After reconstitution, the solution is colorless to slightly yellowish and clear to slightly opaque, and substantially free of visible particles.
Each pack also contains a transfer needle and a filter needle.
Marketing Authorisation Holder:
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
Tel: +800 66838470
Email: medinfoEMEA@takeda.com
Manufacturer:
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
Baxter AG
Industriestrasse 67
1221 Vienna
Austria
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
This leaflet is available in all EU / EEA languages on the European Medicines Agency’s website.