NovoEight

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

turoctocog alfa

Available from:

Novo Nordisk A/S

ATC code:

B02BD02

INN (International Name):

turoctocog alfa

Therapeutic group:

coagulation factor VIII

Therapeutic area:

Hemophilia A

Therapeutic indications:

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

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2013-11-13

Patient Information leaflet

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOEIGHT 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOEIGHT 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOEIGHT 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOEIGHT 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOEIGHT 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOEIGHT 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
turoctocog alfa (human coagulation factor VIII (rDNA))
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 NovoEight is and what it is used for
2.
What you need to know before you use NovoEight
3.
How to use NovoEight
4.
Possible side effects
5.
How to store NovoEight
6.
Contents of the pack and other information
1.
WHAT NOVOEIGHT IS AND WHAT IT IS USED FOR
NovoEight contains the active substance turoctocog alfa, human
coagulation factor VIII. Factor VIII is
a protein naturally found in the blood that helps it to clot.
NovoEight is used to treat and prevent bleeding episodes in patients
with haemophilia A (inborn factor
VIII deficiency) and can be used for all age groups.
In patients with haemophilia A, factor VIII is missing or not working
properly. NovoEight replaces
this faulty or missing ‘factor VIII’ and helps blood to form clots
at the site of bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOEIGHT
DO NOT USE NOVOEIGHT:
•
if you are allergic to the active substance or to any of the other
ingredients of this medicine
(listed in section 6)
•
if you are allergic to

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NovoEight 250 IU powder and solvent for solution for injection
NovoEight 500 IU powder and solvent for solution for injection
NovoEight 1000 IU powder and solvent for solution for injection
NovoEight 1500 IU powder and solvent for solution for injection
NovoEight 2000 IU powder and solvent for solution for injection
NovoEight 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoEight 250 IU powder and solvent for solution for injection.
Each powder vial contains nominally 250 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 62.5 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 500 IU powder and solvent for solution for injection.
Each powder vial contains nominally 500 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 125 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 1000 IU powder and solvent for solution for injection.
Each powder vial contains nominally 1000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 250 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 1500 IU powder and solvent for solution for injection.
Each powder vial contains nominally 1500 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 375 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 2000 IU powder and solvent for solution for injection.
Each powder vial contains nominally 2000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 500 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 3000 IU powder and solvent for solution for injection.
Each powder vial contains nominally 3000 IU human