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.
