Elocta

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

efmoroctocog alfa

Διαθέσιμο από:

Swedish Orphan Biovitrum AB (publ)

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

efmoroctocog alfa

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Hemophilia A

Θεραπευτικές ενδείξεις:

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

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-11-19

Φύλλο οδηγιών χρήσης

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOCTA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 750 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ELOCTA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
efmoroctocog alfa (recombinant coagulation factor VIII)
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, 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 ELOCTA is and what it is used for
2.
What you need to know before you use ELOCTA
3.
How to use ELOCTA
4.
Possible side effects
5.
How to store ELOCTA
6.
Contents of the pack and other information
7.
Instructions for preparation and administration
1.
WHAT ELOCTA IS AND WHAT IT IS USED FOR
ELOCTA contains the active substance efmoroctocog alfa, a recombinant
coagulation factor VIII, Fc fusion
protein. Factor VIII is a protein produced naturally in the body and
is necessary for the blood to form clots
and stop bleeding.
ELOCTA is a medicine used for the treatment and prevention of bleeding
in all age groups of patients with
haemophilia A (inherited bleeding disorder caus

Αρχείο Π.Χ.Π.

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
ELOCTA 250 IU powder and solvent for solution for injection
ELOCTA 500 IU powder and solvent for solution for injection
ELOCTA 750 IU powder and solvent for solution for injection
ELOCTA 1000 IU powder and solvent for solution for injection
ELOCTA 1500 IU powder and solvent for solution for injection
ELOCTA 2000 IU powder and solvent for solution for injection
ELOCTA 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ELOCTA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 83 IU efmoroctocog alfa.
ELOCTA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 167 IU efmoroctocog alfa.
ELOCTA 750 IU powder and solvent for solution for injection
Each vial contains nominally 750 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 250 IU efmoroctocog alfa.
ELOCTA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 333 IU efmoroctocog alfa.
ELOCTA 1500 IU powder and solvent for solution for injection
Each vial contains nominally 1500 IU efmoroctocog alfa. After
reconstitution, each mL of solution for
injection contains approximately 500 IU efmoroctocog alfa.
ELOCTA 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU efmoroctocog alfa. After
reconstitution, each