Country: Indónesía
Tungumál: indónesíska
Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LENOGRASTIM
AVENTIS PHARMA - Indonesia
LENOGRASTIM
263 MCG/VIAL
SERBUK INJEKSI
DUS, 1 VIAL @ 263 MCG + 1 SYRINGE PELARUT @ 1 ML
SANOFI-WINTHROP, FRANCE
2017-08-28
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 Lestu allt skjalið