Rixubis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-09-2022
Charakterystyka produktu
(SPC)
26-09-2022
Sprawozdanie z oceny publicznego
(PAR)
10-02-2015
Składnik aktywny:
Nonacog gamma
Dostępny od:
Baxalta Innovations GmbH
Kod ATC:
B02BD04
INN (International Nazwa):
nonacog gamma
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: 11
Status autoryzacji:
Authorised
Data autoryzacji:
2014-12-19
Ulotka dla pacjenta
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIXUBIS 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
RIXUBIS 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
RIXUBIS 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
RIXUBIS 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
RIXUBIS 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
nonacog gamma (recombinant human 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 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 RIXUBIS is and what it is used for
2.
What you need to know before you use RIXUBIS
3.
How to use RIXUBIS
4.
Possible side effects
5.
How to store RIXUBIS
6.
Contents of the pack and other information
1.
WHAT RIXUBIS IS AND WHAT IT IS USED FOR
RIXUBIS contains the active substance nonacog gamma and is a
coagulation factor IX product. Factor
IX is a normal constituent of human blood necessary for effective
blood clotting. RIXUBIS is used in
patients with haemophilia B (Christmas disease, an inherited bleeding
disorder caused by lack of
factor IX). It works by replacing the missing factor IX to enable the
patient’s blood to clot.
RIXUBIS is used for the treatment and prevention of bleeding in
patients with haemophilia B of all
age groups.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RIXUBIS
DO NOT USE RIXUBIS
-
if you are allergic to nonacog gamma or any of the other ingredients
of this medicine (listed in
section 6)
-
if you are allergic to hamster proteins
WARNINGS AND PRECAUTIONS
Allergic-type hypersensitivity reactions are poss
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
RIXUBIS 250 IU powder and solvent for solution for injection
RIXUBIS 500 IU powder and solvent for solution for injection
RIXUBIS 1000 IU powder and solvent for solution for injection
RIXUBIS 2000 IU powder and solvent for solution for injection
RIXUBIS 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIXUBIS 250 IU powder and solvent for solution for injection
One vial contains nominally 250 IU nonacog gamma, recombinant human
coagulation factor IX
(rDNA), corresponding to a concentration of 50 IU/ml after
reconstitution with 5 ml solvent.
RIXUBIS 500 IU powder and solvent for solution for injection
One vial contains nominally 500 IU nonacog gamma, recombinant human
coagulation factor IX
(rDNA), corresponding to a concentration of 100 IU/ml after
reconstitution with 5 ml solvent.
RIXUBIS 1000 IU powder and solvent for solution for injection
One vial contains nominally 1000 IU nonacog gamma, recombinant human
coagulation factor IX
(rDNA), corresponding to a concentration of 200 IU/ml after
reconstitution with 5 ml solvent.
RIXUBIS 2000 IU powder and solvent for solution for injection
One vial contains nominally 2000 IU nonacog gamma, recombinant human
coagulation factor IX
(rDNA), corresponding to a concentration of 400 IU/ml after
reconstitution with 5 ml solvent.
RIXUBIS 3000 IU powder and solvent for solution for injection
One vial contains nominally 3000 IU nonacog gamma, recombinant human
coagulation factor IX
(rDNA), corresponding to a concentration of 600 IU/ml after
reconstitution with 5 ml solvent.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting assay.
The specific activity of RIXUBIS is approximately 200-390 IU/mg
protein.
Nonacog gamma (recombinant coagulation factor IX) is a single-chain
purified glycoprotein that
has 415 amino acids. It is produced by recombinant DNA technology in a
Chinese hamster ovary
(CHO) cell line.
Excipient(s) with
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