GRANOCYTE 34 SERBUK INJEKSI 263 MCG/VIAL

Country: Indonesia

Language: Indonesian

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

Active ingredient:

LENOGRASTIM

Available from:

AVENTIS PHARMA - Indonesia

INN (International Name):

LENOGRASTIM

Dosage:

263 MCG/VIAL

Pharmaceutical form:

SERBUK INJEKSI

Units in package:

DUS, 1 VIAL @ 263 MCG + 1 SYRINGE PELARUT @ 1 ML

Manufactured by:

SANOFI-WINTHROP, FRANCE

Authorization date:

2017-08-28

Summary of Product characteristics

GRANOCYTE
® 34
LENOGRASTIM
Powder and solvent for solution for injection
SA/555095
--,--,--
IDENTIFICATION OF THE MEDICINAL PRODUCT
NAME OF PRODUCT
GRANOCYTE 34 (33.6 x 106 IU/mL) lyophilized powder in vial and solvent
in pre-filled syringe for
injection or infusion (subcutaneous injection or intravenous
infusion).
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyophilisate :
per vial
Lenograstim* (INN) 33.6 x 10
6
IU**..................................................................................263
micrograms
L-Arginine
.........................................................................................................................................
10 mg
L-Phenylalanine................................................................................................................................
10 mg
L-Methonine
.......................................................................................................................................
1 mg
Mannitol............................................................................................................................................
25 mg
Polysorbate
20..................................................................................................................................
0.1 mg
Hydrochloric
acid........................................................................................................................
q.s pH 6.5
Solvent
:.....................................................................................................................
per pre-filled syringe
Water for
injections.............................................................................................................................
1 mL
* Recombinant glycoprotein (rHuG-CSF) equivalent to the human
Granulocyte Colony Stimulating
Factor isolated from CHU-2, a human cell line. Lenograstim is
expressed and glycosylated in a
mammalian host cell system, Chinese Hamster Ovary (CHO) cells.
** Measurement by the GNFS-60 in vitro bioassay in comparison with t