Adynovi

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rurioctocog alfa pegol

Διαθέσιμο από:

Baxalta Innovations GmbH

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

rurioctocog alfa pegol

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Hemophilia A

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Revision: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-01-08

Φύλλο οδηγιών χρήσης

108
B. PACKAGE LEAFLET
109
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADYNOVI 250 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADYNOVI 500 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADYNOVI 1 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADYNOVI 2 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ADYNOVI 3 000 IU / 5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
rurioctocog alfa pegol (pegylated recombinant human 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.
-
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 ADYNOVI is and what it is used for
2.
What you need to know before you use ADYNOVI
3.
How to use ADYNOVI
4.
Possible side effects
5.
How to store ADYNOVI
6.
Contents of the pack and other information
1.
WHAT ADYNOVI IS AND WHAT IT IS USED FOR
ADYNOVI contains the active substance rurioctocog alfa pegol,
pegylated human coagulation
factor VIII. The human coagulation factor VIII has been modified to
prolong its duration of action.
Factor VIII is necessary for the blood to form clots and stop
bleedings. In patients with haemophilia A
(inborn lack of factor VIII), it is missing or not working properly.
ADYNOVI is used for the treatment and prevention of bleeding in
patients from 12 years of age with
haemophilia A (an inherited bleeding disorder caused by lack of factor
VIII)

Αρχείο Π.Χ.Π.

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
ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection
ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection
ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection
ADYNOVI 2 000 IU / 5 ml powder and solvent for solution for injection
ADYNOVI 3 000 IU / 5 ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), rurioctocog alfa pegol,
corresponding to a concentration of 50 IU/ml after reconstitution with
5 ml solvent.
ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), rurioctocog alfa pegol,
corresponding to a concentration of 100 IU/ml after reconstitution
with 5 ml solvent.
ADYNOVI 1 000 IU / 5 ml powder and solvent for solution for injection
Each vial contains nominally 1 000 IU human coagulation factor VIII
(rDNA), rurioctocog alfa pegol,
corresponding to a concentration of 200 IU/ml after reconstitution
with 5 ml solvent.
ADYNOVI 2 000 IU / 5 ml powder and solvent for solution for injection
Each vial contains nominally 2 000 IU human coagulation factor VIII
(rDNA), rurioctocog alfa pegol,
corresponding to a concentration of 400 IU/ml after reconstitution
with 5 ml solvent.
ADYNOVI 3 000 IU / 5 ml powder and solvent for solution for injection
Each vial contains nominally 3 000 IU human coagulation factor VIII
(rDNA), rurioctocog alfa pegol,
corresponding to a concentration of 600 IU/ml after reconstitution
with 5 ml solvent.
The potency (International Units) is determined usin