Alprolix

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

eftrenonacog alfa

MAH:

Swedish Orphan Biovitrum AB (publ)

ATC_code:

B02BD04

INN:

eftrenonacog alfa

therapeutic_group:

Vitamin K and other hemostatics, Blood coagulation factors

therapeutic_area:

Hemophilia B

therapeutic_indication:

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

leaflet_short:

Revision: 8

authorization_status:

Authorised

authorization_date:

2016-05-12

PIL

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALPROLIX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ALPROLIX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ALPROLIX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ALPROLIX 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ALPROLIX 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion
protein)
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, 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 ALPROLIX is and what it is used for
2.
What you need to know before you use ALPROLIX
3.
How to use ALPROLIX
4.
Possible side effects
5.
How to store ALPROLIX
6.
Contents of the pack and other information
7.
Instructions for preparation and administration
1.
WHAT ALPROLIX IS AND WHAT IT IS USED FOR
ALPROLIX contains the active substance eftrenonacog alfa, recombinant
coagulation factor IX, Fc fusion
protein. Factor IX is a protein produced naturally in the body
necessary for the blood to form clots and stop
bleeding.
ALPROLIX is a medicine used for the treatment and prevention of
bleeding in all age groups of patients
with haemophilia B (inherited bleeding disorder caused by factor IX
deficiency).
ALPROLIX is prepared by recombinant technology without addition of any
human- or animal-derived
components in the manufacturing process.
HOW ALPROLIX WORKS
In patients with haemophilia B, factor IX is missing or not working
properly. This medicine is used to
replace the missing or deficient factor I

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ALPROLIX 250 IU powder and solvent for solution for injection
ALPROLIX 500 IU powder and solvent for solution for injection
ALPROLIX 1000 IU powder and solvent for solution for injection
ALPROLIX 2000 IU powder and solvent for solution for injection
ALPROLIX 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALPROLIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor IX
(rDNA), eftrenonacog alfa.
ALPROLIX contains approximately 250 IU (50 IU/mL) of human coagulation
factor IX (rDNA),
eftrenonacog alfa after reconstitution.
ALPROLIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor IX
(rDNA), eftrenonacog alfa.
ALPROLIX contains approximately 500 IU (100 IU/mL) of human
coagulation factor IX (rDNA),
eftrenonacog alfa after reconstitution.
ALPROLIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor IX
(rDNA), eftrenonacog alfa.
ALPROLIX contains approximately 1000 IU (200 IU/mL) of human
coagulation factor IX (rDNA),
eftrenonacog alfa after reconstitution.
ALPROLIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor IX
(rDNA), eftrenonacog alfa.
ALPROLIX contains approximately 2000 IU (400 IU/mL) of human
coagulation factor IX (rDNA),
eftrenonacog alfa after reconstitution.
ALPROLIX 3000 IU powder and solvent for solution for injection
Each vial contains nominally 3000 IU human coagulation factor IX
(rDNA), eftrenonacog alfa.
ALPROLIX contains approximately 3000 IU (600 IU/mL) of human
coagulation factor IX (rDNA),
eftrenonacog alfa after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test. The specific
activity of ALPROLIX is 55-84 IU/mg protein.
Eftrenonacog alfa (recombinant human coag