Ceprotin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-02-2023
Charakterystyka produktu
(SPC)
02-02-2023
Sprawozdanie z oceny publicznego
(PAR)
02-02-2023
Składnik aktywny:
human protein C
Dostępny od:
Takeda Manufacturing Austria AG
Kod ATC:
B01AD12
INN (International Nazwa):
human protein C
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Purpura Fulminans; Protein C Deficiency
Wskazania:
CEPROTIN is indicated for prophylaxis and treatment of purpura fulminans coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Authorised
Data autoryzacji:
2001-07-16
Ulotka dla pacjenta
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEPROTIN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
human protein C
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 IS IN THIS LEAFLET:
1.
What CEPROTIN is and what it is used for
2.
What you need to know before you use CEPROTIN
3.
How to use CEPROTIN
4.
Possible side effects
5.
How to store CEPROTIN
6.
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 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. CEPROTIN may
also be used in the treatment and prevention of a rare complication of
a blood thinner medicine
(anticoagulant medicine named coumarin) which may result in severe
skin lesion (necrosis).
Additionally, CEPROTIN may be used in the treatment of blood clot
(venous thrombotic) events.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CEPROTIN
DO NOT USE CEPROTIN
-
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
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CEPROTIN 500 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Protein C from human plasma purified by mouse monoclonal antibodies.
CEPROTIN 500 IU* is
prepared as a powder containing nominally 500 IU human protein C per
container. The product
reconstituted with 5 ml of Sterilised Water for Injections contains
approximately 100 IU/ml human
protein C.
The potency (IU) is determined using a chromogenic substrate method
against the World Health
Organisation (WHO) International standard.
*One International Unit (IU) of protein C corresponds to the
amidolytically measured activity of
protein C in 1 ml of normal plasma.
Excipients with known effect:
This medicinal product contains 22.5 mg sodium per vial.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Human protein C, powder and solvent for solution for injection.
Lyophilised white or cream coloured powder or friable solid. After
reconstitution the solution has a pH
of between 6.7 and 7.3 and an osmolality of not lower than 240
mosmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CEPROTIN is indicated for prophylaxis and treatment of purpura
fulminans coumarin-induced
skin necrosis and venous thrombotic events in patients with severe
congenital protein C
deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with CEPROTIN should be initiated under the supervision of a
physician experienced in
substitution therapy with coagulation factors/inhibitors where
monitoring of protein C activity is
feasible.
Posology
The dose should be adjusted on the basis of laboratory assessment for
each individual case.
Treatment of acute episodes and short-term prophylaxis (including
invasive procedures)
A protein C activity of 100 % (1 IU/ml) 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 for determination of recovery and
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