Alprolix 2,000unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eftrenonacog alfa

Available from:

Swedish Orphan Biovitrum Ltd

INN (International Name):

Eftrenonacog alfa

Dosage:

2000unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 7350031441055

Patient Information leaflet

1
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
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, 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
c

Summary of Product characteristics

OBJECT 1
ALPROLIX POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 06-Jul-2017 | Swedish
Orphan Biovitrum Ltd
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
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 eftrenonacog alfa. After
reconstitution, each mL of solution for
injection contains approximately 50 IU eftrenonacog alfa.
ALPROLIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU eftrenonacog alfa. After
reconstitution, each mL of solution for
injection contains approximately 100 IU eftrenonacog alfa.
ALPROLIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU eftrenonacog alfa. After
reconstitution, each mL of solution for
injection contains approximately 200 IU eftrenonacog alfa.
ALPROLIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU eftrenonacog alfa. After
reconstitution, each mL of solution for
injection contains approximately 400 IU eftrenonacog alfa.
ALPROLIX 3000 IU powder and solvent for solution for injection
Each vial contains nominally 3000 IU eftrenonacog alfa. After
reconstitution, each mL of solution for
injection contains approximately 600 IU eftrenonacog alfa.
The potency (International Units) is determined using the European
Pharmacopoeia one stage clotting test
against an in-house standard that