IDELVION 1000 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALBUTREPENONACOG ALFA

Available from:

CSL BEHRING LTD., ISRAEL

ATC code:

B02BD04

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

ALBUTREPENONACOG ALFA 1000 IU

Administration route:

I.V

Prescription type:

Not required

Manufactured by:

CSL BEHRING GMBH, GERMANY

Therapeutic area:

COAGULATION FACTOR IX

Therapeutic indications:

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

Authorization date:

2022-09-30

Summary of Product characteristics

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