NOVOEIGHT

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

TUROCTOCOG ALFA

Pieejams no:

BETA PHARMACON - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

TUROCTOCOG ALFA

Deva:

250 IU

Zāļu forma:

SERBUK INJEKSI

Vienības iepakojumā:

DUS, 1 VIAL @ 250 IU + 1 PRE-FILLED SYRINGE PELARUT @ 4 ML + 1 ST...

Ražojis:

NOVO NORDISK A/S - Denmark

Autorizācija datums:

2020-08-22

Produkta apraksts

STF APR 2021
Page 1 of 21
1.
NAME OF THE MEDICINAL PRODUCT
NOVOEIGHT
®
250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each powder vial contains nominally 250, 500 or 1000 IU human
coagulation factor VIII
(rDNA), turoctocog alfa.
After reconstitution NovoEight
®
contains approximately 62.5, 125 or 250 IU/ml of human
coagulation factor VIII (rDNA), turoctocog alfa.
The potency (IU) is determined using the European Pharmacopoeia (Ph.
Eur) chromogenic
assay. The specific activity of NovoEight
®
is approximately 8,300 IU/mg protein.
Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified
protein that has 1,445
amino acids with an approximate molecular mass of 166 kDA. It is
produced by recombinant
DNA technology in Chinese hamster ovary (CHO) cells and prepared
without the addition of
any human or animal derived protein in the cell culture process,
purification or final
formulation.
Turoctocog alfa is a B-domain truncated recombinant human coagulation
factor VIII (B-
domain consists of 21 amino acids of the wild type B-domain) without
any other
modifications in the amino acid sequence.
_Excipient with known effect_
The medicinal product contains 30.5 mg sodium per reconstituted vial.
For the full list of excipients, see section 6.1_._
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly yellow powder or friable mass.
Clear and colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency).
NovoEight
®
can be used for all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a doctor experienced in
the treatment of
haemophilia.
DISETUJUI OLEH BPOM: 30 JULI 2022
ID FERO: EREG100383VR12200014-16
STF APR 2021
Page 2 of 21
Treatment monitoring
Dur