Jivi

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Damoctocog alfa pegol

Διαθέσιμο από:

Bayer AG

Φαρμακολογική κατηγορία (ATC):

B02BD02

INN (Διεθνής Όνομα):

damoctocog alfa pegol

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Hemophilia A

Θεραπευτικές ενδείξεις:

Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).

Περίληψη προϊόντος:

Revision: 5

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-11-22

Φύλλο οδηγιών χρήσης

73
B. PACKAGE LEAFLET
74
PACKAGE LEAFLET: INFORMATION FOR THE USER
JIVI 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
JIVI 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
JIVI 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
JIVI 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
JIVI 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
PEGylated B-domain deleted recombinant human coagulation factor VIII
(damoctocog alfa pegol)
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 Jivi is and what it is used for
2.
What you need to know before you use Jivi
3.
How to use Jivi
4.
Possible side effects
5.
How to store Jivi
6.
Contents of the pack and other information
1.
WHAT JIVI IS AND WHAT IT IS USED FOR
Jivi contains the active substance damoctocog alfa pegol. It is
produced 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. The protein in damoctocog
alfa pegol has been modified (pegylated) to prolong its action in the
body.
Jivi is used to TREAT AND PREVENT BLEEDING in previously treated
adults and adolescents aged from
12 years with haemophilia A (hereditary factor VIII deficiency). It is
not for use in children younger
than 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JIVI
DO NOT USE JIVI if you are
•
allergic to damoctocog alfa pegol or any of the other ingredients of
this medicine (listed in
section 6).
•
allergic to mou

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Jivi 250 IU powder and solvent for solution for injection
Jivi 500 IU powder and solvent for solution for injection
Jivi 1000 IU powder and solvent for solution for injection
Jivi 2000 IU powder and solvent for solution for injection
Jivi 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jivi 250 IU powder and solvent for solution for injection
After reconstitution with the solvent provided, one mL of solution
contains approximately 100 IU
(250 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa
pegol.
Jivi 500 IU powder and solvent for solution for injection
After reconstitution with the solvent provided, one mL of solution
contains approximately 200 IU
(500 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa
pegol.
Jivi 1000 IU powder and solvent for solution for injection
After reconstitution with the solvent provided, one mL of solution
contains approximately 400 IU
(1 000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa
pegol.
Jivi 2000 IU powder and solvent for solution for injection
After reconstitution with the solvent provided, one mL of solution
contains approximately 800 IU
(2 000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa
pegol.
Jivi 3000 IU powder and solvent for solution for injection
After reconstitution with the solvent provided, one mL of solution
contains approximately 1 200 IU
(3 000 IU/2.5 mL) of human coagulation factor
VIII, damoctocog alfa pegol.
The potency International Unit (IU) is determined using the European
Pharmacopoeia chromogenic
assay. The specific activity of Jivi is approximately 10 000 IU/mg
protein.
The active substance, damoctocog alfa pegol, is a site specifically
PEGylated B-domain deleted
recombinant human coagulation factor VIII, produced in baby hamster
kidney cells (BHK), with a
60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety. The
molecular weight of the protein
is approximately 234 k