Esperoct

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Turoctocog alfa pegol

Available from:

Novo Nordisk A/S

ATC code:

B02BD02

INN (International Name):

turoctocog alfa pegol

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemophilia A

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2019-06-20

Patient Information leaflet

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESPEROCT 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 1
000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 1
500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 2
000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 3
000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 4
000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ESPEROCT 5
000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA))
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.
–
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 Esperoct is and what it is used for
2.
What you need to know before you use Esperoct
3.
How to use Esperoct
4.
Possible side effects
5.
How to store Esperoct
6.
Contents of the pack and other information
1.
WHAT ESPEROCT
IS AND WHAT IT IS USED FOR
WHAT ESPEROCT IS
Esperoct contains the active substance turoctocog alfa pegol and is a
long-acting recombinant
coagulation factor VIII product. Factor VIII is a protein found in the
blood that helps to prevent and
stop bleeding.
WHAT ESPEROCT IS USED FOR
Esperoct is used to treat and prevent bleeding in people 12 years and
above with haemophilia A
(inborn factor VIII deficiency).
In people with haemophilia A, factor VIII is missi

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Esperoct 500 IU powder and solvent for solution for injection
Esperoct 1 000 IU powder and solvent for solution for injection
Esperoct 1 500 IU powder and solvent for solution for injection
Esperoct 2 000 IU powder and solvent for solution for injection
Esperoct 3 000 IU powder and solvent for solution for injection
Esperoct 4 000 IU powder and solvent for solution for injection
Esperoct 5 000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esperoct 500 I
U powder and solvent for solution for injection
Each powder vial contains nominally 500 IU turoctocog alfa pegol*.
After reconstitution, 1 mL of solution contains approximately 125 IU
turoctocog alfa pegol.
Esperoct 1 000 IU powder and solvent for solution for injection
Each powder vial contains nominally 1 000 IU turoctocog alfa pegol*.
After reconstitution, 1 mL of solution contains approximately 250 IU
turoctocog alfa pegol.
Esperoct 1 500 IU powder and solvent for solution for injection
Each powder vial contains nominally 1 500 IU turoctocog alfa pegol*.
After reconstitution, 1 mL of solution contains approximately 375 IU
turoctocog alfa pegol.
Esperoct 2 0
00 IU powder and solvent for solution for injection
Each powder vial contains nominally 2 000 IU turoctocog alfa pegol*.
After reconstitution, 1 mL of solution contains approximately 500 IU
turoctocog alfa pegol.
Esperoct 3 0
00 IU powder and solvent for solution for injection
Each powder vial contains nominally 3 000 IU turoctocog alfa pegol*.
After reconstitution, 1 mL of solution contains approximately 750 IU
turoctocog alfa pegol.
Esperoct 4 000 IU powder and solvent for solution for injection
Each powder vial contains nominally