ELOCTA 2000 IU

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

COAGULATION FACTOR VIII

Verfügbar ab:

MEGAPHARM LTD

ATC-Code:

B02BD05

Darreichungsform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Zusammensetzung:

COAGULATION FACTOR VIII 2000 IU

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

SWEDISH ORPHAN BIOVITRUM AB (PUBL), SWEDEN

Therapiebereich:

COAGULATION FACTOR VII

Anwendungsgebiete:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).ELOCTA can be used for all age groups.

Berechtigungsdatum:

2022-08-31

Gebrauchsinformation

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
ELOCTA 250, 500, 1000, 2000, 3000 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
THE MEDICINE’S NAME, FORM AND STRENGTH:
EACH VIAL OF POWDER CONTAINS:
RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 250 IU
RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 500 IU
RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 1000 IU
RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 2000 IU
RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 3000 IU
AFTER BEING DISSOLVED IN WATER FOR INJECTION:
1 ml of
ELOCTA 250 IU
contains approximately 83 IU (250 IU / 3 ml) of recombinant human
coagulation
factor VIII
1 ml of
ELOCTA 500 IU
contains approximately 167 IU (500 IU / 3 ml) of recombinant human
coagulation
factor VIII
1 ml of
ELOCTA 1000 IU
contains approximately 333 IU (1000 IU / 3 ml) of recombinant human
coagulation factor VIII
1 ml of
ELOCTA 2000 IU
contains approximately 667 IU (2000 IU / 3 ml) of recombinant human
coagulation factor VIII
1 ml of
ELOCTA 3000 IU
contains approximately 1000 IU (3000 IU / 3 ml) of recombinant human
coagulation factor VIII
Inactive and allergenic ingredients: see section 6 “Additional
information” and section 2 “Important
information about some of the medicine’s ingredients”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, consult
with your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even
if it seems to you that their illness is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
ELOCTA
is intended for the treatment and prophylaxis of bleeding in patients
with hemophilia A (congenital
coagulation factor VIII deficiency).
THERAPEUTIC GROUP: ELOCTA
belongs to a class of bleed

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ELOCTA 250 IU powder and solvent for solution for injection
ELOCTA 500 IU powder and solvent for solution for injection
ELOCTA 1000 IU powder and solvent for solution for injection
ELOCTA 2000 IU powder and solvent for solution for injection
ELOCTA 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ELOCTA 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU (33.3 mcg/vial) efmoroctocog alfa.
ELOCTA contains approximately 83 IU/mL of recombinant human
coagulation factor VIII, efmoroctocog
alfa after reconstitution.
ELOCTA 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU (66.7mcg/vial) efmoroctocog alfa.
ELOCTA contains approximately 167 IU/mL of recombinant efmoroctocog
alfa after reconstitution.
ELOCTA 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU (133.3 mcg/vial) efmoroctocog
alfa.
ELOCTA contains approximately 333 IU/mL of recombinant efmoroctocog
alfa after reconstitution.
ELOCTA 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU (266.7 mcg/vial) efmoroctocog
alfa.
ELOCTA contains approximately 667 IU/mL of recombinant efmoroctocog
alfa after reconstitution.
ELOCTA 3000 IU powder and solvent for solution for injection
Each vial contains nominally 3000 IU (400mcg/vial) efmoroctocog alfa.
ELOCTA contains approximately 1000 IU/mL of recombinant efmoroctocog
alfa after reconstitution.
The potency (International Units (IU)) is determined using the
European Pharmacopoeia chromogenic assay.
The specific activity of ELOCTA is 4000-10200 IU/mg protein.
Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc
fusion protein (rFVIIIFc)) has
1,890 amino acids. It is produced by recombinant DNA technology in a
human embryonic kidney (HEK) cell
line without the addition of any exogenous human- or animal-derived
protein in the cell culture proc