Iblias
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
27-04-2018
Vara einkenni
(SPC)
27-04-2018
Opinber matsskýrsla
(PAR)
09-03-2016
Virkt innihaldsefni:
Octocog alfa
Fáanlegur frá:
Bayer AG
ATC númer:
B02BD02
INN (Alþjóðlegt nafn):
octocog alfa
Meðferðarhópur:
Antihemorrhagics
Lækningarsvæði:
Hemophilia A
Ábendingar:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Iblias can be used for all age groups.
Vörulýsing:
Revision: 4
Leyfisstaða:
Withdrawn
Leyfisdagur:
2016-02-18
Upplýsingar fylgiseðill
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBLIAS 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IBLIAS 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IBLIAS 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IBLIAS 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
IBLIAS 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Recombinant human coagulation factor VIII (octocog alfa)
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 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 Iblias is and what it is used for
2.
What you need to know before you use Iblias
3.
How to use Iblias
4.
Possible side effects
5.
How to store Iblias
6.
Contents of the pack and other information
1.
WHAT IBLIAS IS AND WHAT IT IS USED FOR
Iblias is a medicine that contains the active substance human
recombinant coagulation factor VIII, also
called octocog alfa. Iblias 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.
Iblias is used for treatment and prevention of bleeding in adults,
adolescents and children of all ages
with haemophilia A (congenital factor VIII deficiency).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IBLIAS
DO NOT USE IBLIAS
if you are all
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Vara einkenni
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
Iblias 250 IU powder and solvent for solution for injection
Iblias 500 IU powder and solvent for solution for injection
Iblias 1000 IU powder and solvent for solution for injection
Iblias 2000 IU powder and solvent for solution for injection
Iblias 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains nominally 250/500/1000/2000/3000 IU human
coagulation factor VIII.
One mL Iblias 250 IU contains approximately 100 IU (250 IU / 2.5 mL)
of recombinant human
coagulation factor VIII (INN: octocog alfa) after reconstitution with
water for injections.
One mL Iblias 500 IU contains approximately 200 IU (500 IU / 2.5 mL)
of recombinant human
coagulation factor VIII (INN: octocog alfa) after reconstitution with
water for injections.
One mL Iblias 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL)
of recombinant
human coagulation factor VIII (INN: octocog alfa) after reconstitution
with water for injections.
One mL Iblias 2000 IU contains approximately 400 IU (2000 IU / 5 mL)
of recombinant human
coagulation factor VIII (INN: octocog alfa) after reconstitution with
water for injections.
One mL Iblias 3000 IU contains approximately 600 IU (3000 IU / 5 mL)
of recombinant human
coagulation factor VIII (INN: octocog alfa) after reconstitution with
water for injections.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The specific
activity of Iblias 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
ce
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