FULPHILA

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

PEGFILGRASTIM

Disponible depuis:

INDOFARMA - Indonesia

DCI (Dénomination commune internationale):

PEGFILGRASTIM

Dosage:

6 MG

forme pharmaceutique:

CAIRAN INJEKSI

Unités en paquet:

BOX OF 1 BLISTER @ 1 PREFILLED SYRINGE @ 0,6 ML

Fabriqué par:

BIOCON LIMITED - India

Date de l'autorisation:

2021-02-22

Résumé des caractéristiques du produit

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