Helixate NexGen
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-06-2020
Charakterystyka produktu
(SPC)
02-06-2020
Sprawozdanie z oceny publicznego
(PAR)
02-06-2020
Składnik aktywny:
Octocog alfa
Dostępny od:
Bayer AG
Kod ATC:
B02BD02
INN (International Nazwa):
octocog alfa
Grupa terapeutyczna:
Antihemorrhagics
Dziedzina terapeutyczna:
Hemophilia A
Wskazania:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Podsumowanie produktu:
Revision: 31
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-08-04
Ulotka dla pacjenta
23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
HELIXATE NEXGEN 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HELIXATE NEXGEN 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Recombinant coagulation factor VIII (octocog alfa)
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 your 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 Helixate NexGen is and what it is used for
2.
What you need to know before you use Helixate NexGen
3.
How to use Helixate NexGen
4.
Possible side effects
5.
How to store Helixate NexGen
6.
Contents of the pack and other information
1.
WHAT HELIXATE NEXGEN IS AND WHAT IT IS USED FOR
Helixate NexGencontains the active substance human recombinant
coagulation factor VIII (octocog
alfa).
Helixate NexGen is used for treatment and prophylaxis of bleeding
adults, adolescents and children of
all ages with haemophilia A (congenital factor VIII deficiency).
This preparation does not contain von Willebrand factor and is
therefore not to be used in von
Willebrand's disease.
The vial contains a dry white to slightly yellow powder or cake, as
well as water for injections to be
used to reconstitute the contents of the vial.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HELIXATE NEXGEN
DO NOT USE HELIXATE NEXGEN
if you are allergic to octocog alfa or to any of the oth
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Helixate NexGen 250 IU powder and solvent for solution for injection
Helixate NexGen 500 IU powder and solvent for solution for injection
Helixate NexGen 1000 IU powder and solvent for solution for injection
Helixate NexGen 2000 IU powder and solvent for solution for injection
Helixate NexGen 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 (INN:
octocog alfa).
Human coagulation factor VIII is produced by recombinant DNA
technology (rDNA) in baby hamster
kidney cells containing the human factor VIII gene.
One mL Helixate NexGen 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 Helixate NexGen 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 Helixate NexGen 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 Helixate NexGen 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 Helixate NexGen 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 one-stage clotting assay
against the FDA Mega standard
which was calibrated against WHO standard in International Units (IU).
The specific activity of Helixate NexGen is approximately 4000 IU/mg
protein.
For the full list of excipients, see section 6.1.
3.
PHARMACEU
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