Refixia
Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Foglio illustrativo
(PIL)
06-11-2023
Scheda tecnica
(SPC)
06-11-2023
Relazione pubblica di valutazione
(PAR)
06-11-2023
Principio attivo:
Nonacog beta pegol
Commercializzato da:
Novo Nordisk A/S
Codice ATC:
B02BD04
INN (Nome Internazionale):
nonacog beta pegol
Gruppo terapeutico:
Antihemorrhagics
Area terapeutica:
Hemophilia B
Indicazioni terapeutiche:
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency)., Refixia can be used for all age groups.,
Dettagli prodotto:
Revision: 5
Stato dell'autorizzazione:
Authorised
Data dell'autorizzazione:
2017-06-02
Foglio illustrativo
34
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B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
REFIXIA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFIXIA 1 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFIXIA 2 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
REFIXIA 3 000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
nonacog beta pegol
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
•
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Refixia is and what it is used for
2.
What you need to know before you use Refixia
3.
How to use Refixia
4.
Possible side effects
5.
How to store Refixia
6.
Contents of the pack and other information
1.
WHAT REFIXIA IS AND WHAT IT IS USED FOR
WHAT REFIXIA IS
Refixia contains the active substance nonacog beta pegol. It is a
long-acting version of factor IX.
Factor IX is a protein naturally found in the blood that helps to stop
bleeding.
WHAT REFIXIA
IS USED FOR
Refixia is used to treat and prevent bleeding in all age groups of
patients with haemophilia B (inborn
factor IX deficiency).
In patients with haemophilia B, factor IX is missing or does not work
properly. Refixia replaces this
faulty or missing factor IX and helps blood to form clots at the site
of bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REFIXIA
DO NOT USE REFIXIA
•
if you are allergic to the active substance or any of the other
ingredients of
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Scheda tecnica
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Refixia 500 IU powder and solvent for solution for injection
Refixia 1 000 IU powder and solvent for solution for injection
Refixia 2 000 IU powder and solvent for solution for injection
Refixia 3 000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Refixia 500 I
U powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog beta pegol*.
After reconstitution, 1 ml of Refixia contains approximately 125 IU
nonacog beta pegol.
Refixia 1 000 IU
powder and solvent for solution for injection
Each vial contains nominally 1 000 IU nonacog beta pegol*.
After reconstitution, 1 ml of Refixia contains approximately 250 IU
nonacog beta pegol.
Refixia 2 000 IU
powder and solvent for solution for injection
Each vial contains nominally 2 000 IU nonacog beta pegol*.
After reconstitution, 1 ml of Refixia contains approximately 500 IU
nonacog beta pegol.
Refixia 3 000 IU
powder and solvent for solution for injection
Each vial contains nominally 3 000 IU nonacog beta pegol*.
After reconstitution, 1 ml of Refixia contains approximately 750 IU
nonacog beta pegol.
*recombinant human factor IX, produced in Chinese Hamster Ovary (CHO)
cells by recombinant
DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol
(PEG).
The potency (IU) is determined using the European Pharmacopoeia
one-stage clotting test. The
specific activity of Refixia is approximately 144 IU/mg protein.
Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa
polyethylene-glycol (PEG)
selectively attached to specific N-linked glycans in the rFIX
activation peptide. Upon activation of
Refixia, the activation peptide including the 40 kDa
polye
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