IDELVION 1000 IU

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ALBUTREPENONACOG ALFA

Tilgængelig fra:

CSL BEHRING LTD., ISRAEL

ATC-kode:

B02BD04

Lægemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammensætning:

ALBUTREPENONACOG ALFA 1000 IU

Indgivelsesvej:

I.V

Recept type:

Not required

Fremstillet af:

CSL BEHRING GMBH, GERMANY

Terapeutisk område:

COAGULATION FACTOR IX

Terapeutiske indikationer:

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Autorisation dato:

2022-09-30

Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT
IDELVION 250 IU powder and solvent for solution for injection
IDELVION 500 IU powder and solvent for solution for injection
IDELVION 1000 IU powder and solvent for solution for injection
IDELVION 2000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IDELVION 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), ( albutrepenonacog alfa). After reconstitution with
2.5 ml water for injections the
solution contains 100 IU/ml of albutrepenonacog alfa.
IDELVION 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU of recombinant fusion protein
linking coagulation factor IX with
albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution with
2.5 ml water for injections the
solution contains 200 IU/ml of albutrepenonacog alfa.
IDELVION 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU of recombinant fusion protein
linking coagulation factor IX
with albumin (rIX-FP), ( albutrepenonacog alfa). After reconstitution
with 2.5 ml water for injections
the solution contains 400 IU/ml of albutrepenonacog alfa.
IDELVION 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU of recombinant fusion protein
linking coagulation factor IX
with albumin (rIX-FP), (albutrepenonacog alfa). After reconstitution
with 5 ml water for injections the
solution contains 400 IU/ml of albutrepenonacog alfa.
The potency (IU) is determined using the European Pharmacopeia one
stage clotting test. The specific
activity of IDELVION is approximately 54 – 85 IU/mg protein.
.
Albutrepenonacog alfa is a purified protein produced by recombinant
DNA technology, generated by
the genetic fusion of recombinant albumin to recombinant coagulation
factor IX. The genetic fusion of
the cDNA of human albumin to the cDNA of human coagulation factor IX
enables t