Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PEGFILGRASTIM
INDOFARMA - Indonesia
PEGFILGRASTIM
6 MG
CAIRAN INJEKSI
BOX OF 1 BLISTER @ 1 PREFILLED SYRINGE @ 0,6 ML
BIOCON LIMITED - India
2021-02-22
DISETUJUI OLEH BPOM 4 FEBRUARI 2021 ID REG: EREG10021811900022 SUMMARY OF PRODUCT CHARACTERISTICS FULPHILA ™ (PEGFILGRASTIM) PEGYLATED GRANULOCYTE COLONY STIMULATING FACTOR INJECTION (PEG-GCSF INJECTION) 6 MG/0.6 ML FOR SUBCUTANEOUS USE ONLY STERILE SOLUTION - NO PRESERVATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection. The concentration is 10 mg/ml based on protein only**. *Produced in _Escherichia _ _coli_ cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ml if the PEG moiety is included. The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. EXCIPIENT(S) WITH KNOWN EFFECT Each pre-filled syringe contains 30-mg sorbitol For a full list of excipients, see section LIST OF EXCIPIENTS. PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe (injection). Clear, colourless solution for injection. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13. Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent DISETUJUI OLEH BPOM 4 FEBRUARI 2021 ID REG: EREG10021811900022 conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule. Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. Similarly, to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with other haematopoietic growth fac Lesen Sie das vollständige Dokument