Idelvion
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-09-2023
Charakterystyka produktu
(SPC)
18-09-2023
Sprawozdanie z oceny publicznego
(PAR)
27-05-2016
Składnik aktywny:
albutrepenonacog alfa
Dostępny od:
CSL Behring GmbH
Kod ATC:
B02BD04
INN (International Nazwa):
albutrepenonacog alfa
Grupa terapeutyczna:
Antihemorrhagics
Dziedzina terapeutyczna:
Hemophilia B
Wskazania:
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2016-05-11
Ulotka dla pacjenta
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
IDELVION 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IDELVION 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IDELVION 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IDELVION 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IDELVION 3500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
albutrepenonacog alfa (recombinant coagulation factor IX)
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 further questions, ask your doctor, pharmacist or nurse.
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What IDELVION is and what it is used for
2.
What you need to know before you use IDELVION
3.
How to use IDELVION
4.
Possible side effects
5.
How to store IDELVION
6.
Contents of the pack and other information
1.
WHAT IDELVION IS AND WHAT IT IS USED FOR
WHAT IS IDELVION?
IDELVION is a haemophilia medicine that replaces a natural blood
clotting (coagulation) factor IX.
The active substance in IDELVION is albutrepenonacog alfa (recombinant
fusion protein linking
coagulation factor IX with albumin (rIX-FP)).
Factor IX is involved in blood clotting. Patients with haemophilia B
have a lack of this factor which
means that their blood does not clot as quickly as it should so there
is an increased tendency to bleed.
IDELVION works by replacing factor IX in haemophilia B patients to
enable their blood to clot.
WHAT IS IDELVION USED FOR?
IDELVION is used to prevent or to halt bleeding caused by the lack of
factor IX in patients of all age
groups with haemophilia B (also called congenital factor IX deficiency
or Christ
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IDELVION 250 IU powder and solvent for solution for injection
IDELVION 500 IU powder and solvent for solution for injection
IDELVION 1000 IU powder and solvent for solution for injection
IDELVION 2000 IU powder and solvent for solution for injection
IDELVION 3500 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IDELVION 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with
2.5 ml water for injections the
solution contains 100 IU/ml of albutrepenonacog alfa.
IDELVION 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with
2.5 ml water for injections the
solution contains 200 IU/ml of albutrepenonacog alfa.
IDELVION 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with
2.5 ml water for injections the
solution contains 400 IU/ml of albutrepenonacog alfa.
IDELVION 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 5
ml water for injections the
solution contains 400 IU/ml of albutrepenonacog alfa.
IDELVION 3500 IU powder and solvent for solution for injection
Each vial contains nominally 3500 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with 5
ml water for injections the
solution contains 700 IU/ml of albutrepenonacog alfa.
The potency (IU) is
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