ReFacto AF

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

moroctocog alfa

Διαθέσιμο από:

Pfizer Europe MA EEIG

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

moroctocog alfa

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Hemophilia A

Θεραπευτικές ενδείξεις:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.,

Περίληψη προϊόντος:

Revision: 40

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1999-04-13

Φύλλο οδηγιών χρήσης

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ReFacto AF 250 IU powder and solvent for solution for injection
ReFacto AF 500 IU powder and solvent for solution for injection
ReFacto AF 1000 IU powder and solvent for solution for injection
ReFacto AF 2000 IU powder and solvent for solution for injection
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 500 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 1000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 2000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 3000 IU powder and solvent for solution for injection in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ReFacto AF 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 62.5
IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 125
IU moroctocog alfa.
ReFacto AF 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 250
IU moroctocog alfa.
ReFacto AF 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 500
IU moroctocog alfa.
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 62.5
IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection in
pre-filled syringe
Each pre-filled syringe contains nominally 500 IU* moroctoco

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ReFacto AF 250 IU powder and solvent for solution for injection
ReFacto AF 500 IU powder and solvent for solution for injection
ReFacto AF 1000 IU powder and solvent for solution for injection
ReFacto AF 2000 IU powder and solvent for solution for injection
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 500 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 1000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 2000 IU powder and solvent for solution for injection in
pre-filled syringe
ReFacto AF 3000 IU powder and solvent for solution for injection in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ReFacto AF 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 62.5
IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 125
IU moroctocog alfa.
ReFacto AF 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 250
IU moroctocog alfa.
ReFacto AF 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 500
IU moroctocog alfa.
ReFacto AF 250 IU powder and solvent for solution for injection in
pre-filled syringe
Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**.
After reconstitution, each mL of solution contains approximately 62.5
IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection in
pre-filled syringe
Each pre-filled syringe contains nominally 500 IU* moroctoco