Idelvion 250unit powder and solvent for solution for injection vials

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Albutrepenonacog alfa

Prieinama:

CSL Behring UK Ltd

INN (Tarptautinis Pavadinimas):

Albutrepenonacog alfa

Dozė:

250unit

Vaisto forma:

Powder and solvent for solution for injection

Vartojimo būdas:

Intravenous

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: ; GTIN: 5028360001104

Pakuotės lapelis

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
Albutrepenonacog alfa
P
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 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

Prekės savybės

OBJECT 1
IDELVION 250 IU POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 31-Jan-2018 | CSL Behring
UK Limited
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
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
2. Qualitative and quantitative composition
IDELVION 250 IU powder and solvent for solution for injection
One vial contains nominally 250 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (INN = 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
One vial contains nominally 500 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (INN = 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
One vial contains nominally 1000 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (INN = 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
One vial contains nominally 2000 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (INN = albutrepenonacog alfa). After reconstitution
with 5 ml water for injections the
solution contains 400 IU/ml of albutrepenonacog alfa.
The pote