Kovaltry
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
26-07-2022
Fachinformation
(SPC)
26-07-2022
Öffentlichen Beurteilungsberichts
(PAR)
07-03-2016
Wirkstoff:
Octocog alfa
Verfügbar ab:
Bayer AG
ATC-Code:
B02BD02
INN (Internationale Bezeichnung):
octocog alfa
Therapiegruppe:
Antihemorrhagics
Therapiebereich:
Hemophilia A
Anwendungsgebiete:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
Produktbesonderheiten:
Revision: 12
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2016-02-18
Gebrauchsinformation
71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE USER
KOVALTRY 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOVALTRY 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOVALTRY 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOVALTRY 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOVALTRY 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
octocog alfa (recombinant human coagulation factor VIII)
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kovaltry is and what it is used for
2.
What you need to know before you use Kovaltry
3.
How to use Kovaltry
4.
Possible side effects
5.
How to store Kovaltry
6.
Contents of the pack and other information
1.
WHAT KOVALTRY IS AND WHAT IT IS USED FOR
Kovaltry contains the active substance human recombinant coagulation
factor VIII, also called
octocog alfa. Kovaltry is prepared by recombinant technology without
addition of any human- or
animal derived components in the manufacturing process. Factor VIII is
a protein naturally found in
the blood that helps to clot it.
Kovaltry is used to
TREAT AND PREVENT
BLEEDING
in adults, adolescents and children of all ages with
haemophilia A (hereditary factor VIII deficiency).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KOVALTRY
DO NOT USE KOVALTRY
if you are
•
allergic to octocog alfa or to any of the other ingredients of this
medicine (listed in section 6).
•
allergic to mouse or hamster proteins.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST
if you have:
•
tightness in
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kovaltry 250 IU powder and solvent for solution for injection
Kovaltry 500 IU powder and solvent for solution for injection
Kovaltry 1000 IU powder and solvent for solution for injection
Kovaltry 2000 IU powder and solvent for solution for injection
Kovaltry 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kovaltry 250 I
U powder and solvent for solution for injection
Kovaltry contains approximately 250 IU (100 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
Kovaltry 500 IU powder and solvent for solution for injection
Kovaltry contains approximately 500 IU (200 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
Kovaltry 1000 IU powder and solvent for solution for injection
Kovaltry contains approximately 1000 IU (400 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
Kovaltry 2000 IU powder and solvent for solution for injection
Kovaltry contains approximately 2000 IU (400 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
Kovaltry 3000 IU powder and solvent for solution for injection
Kovaltry contains approximately 3000 IU (600 IU / 1 mL) of recombinant
human coagulation
factor VIII (INN: octocog alfa) after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific
activity of Kovaltry is approximately 4000 IU/mg protein.
Octocog alfa (Full length recombinant human coagulation factor VIII
(rDNA)) is a purified protein
that has 2,332 amino acids. It is produced by recombinant DNA
technology in baby hamster kidney
cells (BHK) into which the human factor VIII gene has been introduced.
Kovaltry is prepared without
the addition of any human or animal derived protein in the cell
culture process, purification or final
formulation.
For the full list of
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