Nuwiq

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

simoctocog alfa

Saadav alates:

Octapharma AB

ATC kood:

B02BD02

INN (Rahvusvaheline Nimetus):

simoctocog alfa

Terapeutiline rühm:

Blood coagulation factors

Terapeutiline ala:

Hemophilia A

Näidustused:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Nuwiq can be used for all age groups.

Toote kokkuvõte:

Revision: 13

Volitamisolek:

Authorised

Loa andmise kuupäev:

2014-07-22

Infovoldik

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUWIQ 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NUWIQ 4000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
simoctocog alfa (recombinant human coagulation factor VIII)
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 Nuwiq is and what it is used for
2.
What you need to know before you use Nuwiq
3.
How to use Nuwiq
4.
Possible side effects
5.
How to store Nuwiq
6.
Contents of the pack and other information
1.
WHAT NUWIQ IS AND WHAT IT IS USED FOR
Nuwiq contains the active substance human recombinant coagulation
factor VIII (simoctocog alfa).
Factor VIII is necessary for the blood to form clots and stop
bleeding. In patients with haemophilia A
(inborn factor VIII deficiency), factor VIII is missing or not working
properly.
Nuwiq replaces the missing factor VIII and is used for treatment and
prevention of bleeding in patients
with haemophilia A and can be used for all age groups.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUWIQ
DO NOT USE NUWIQ
•
if you are allergic to the active substance simoctocog alfa or any of
the other ingredients of
this medicine (listed in section 6).
If you are unsure about

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nuwiq 250 IU powder and solvent for solution for injection
Nuwiq 500 IU powder and solvent for solution for injection
Nuwiq 1000 IU powder and solvent for solution for injection
Nuwiq 1500 IU powder and solvent for solution for injection
Nuwiq 2000 IU powder and solvent for solution for injection
Nuwiq 2500 IU powder and solvent for solution for injection
Nuwiq 3000 IU powder and solvent for solution for injection
Nuwiq 4000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nuwiq 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 1500 IU contains approximately 600 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), simoctocog alfa.
Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation
factor VIII (rDNA),
simoctocog alfa after reconstitution.
Nuwiq 2500 IU powder and solvent for solution for injection
Ea