Rixubis 500unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nonacog gamma

Available from:

Baxalta UK Ltd

INN (International Name):

Nonacog gamma

Dosage:

500unit

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:

Patient Information leaflet

42
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)
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 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 all

Summary of Product characteristics

OBJECT 1
RIXUBIS 250 IU, 500 IU, 1000 IU, 2000 IU &
3000 IU POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 13-Jun-2016 | Shire
Pharmaceuticals 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
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