IDELVION 1000 IU

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

ALBUTREPENONACOG ALFA

Pieejams no:

CSL BEHRING LTD., ISRAEL

ATĶ kods:

B02BD04

Zāļu forma:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Kompozīcija:

ALBUTREPENONACOG ALFA 1000 IU

Ievadīšanas:

I.V

Receptes veids:

Not required

Ražojis:

CSL BEHRING GMBH, GERMANY

Ārstniecības joma:

COAGULATION FACTOR IX

Ārstēšanas norādes:

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

Autorizācija datums:

2022-09-30

Produkta apraksts

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