CAELYX

Land: Indonesië

Taal: Indonesisch

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

Werkstoffen:

DOXORUBICIN HYDROCHLORIDE

Beschikbaar vanaf:

SOHO INDUSTRI PHARMASI - Indonesia

INN (Algemene Internationale Benaming):

DOXORUBICIN HYDROCHLORIDE

Dosering:

2 MG/ML

farmaceutische vorm:

INFUS

Eenheden in pakket:

DUS, 1 VIAL @ 10 ML

Geproduceerd door:

GLAXOSMITHKLINE MANUFACTURING S.P.A. - Italy

Autorisatie datum:

2019-12-04

Productkenmerken

Page 1
CAELYX

CONCENTRATE FOR INFUSION
PEGYLATED LIPOSOMAL DOXORUBICIN HYDROCHLORIDE
INTERNATIONAL NON-PROPRIETARY NAME
Pegylated liposomal doxorubicin hydrochloride
FOR SINGLE USE INTRAVENOUS ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CAELYX
®
, a liposome formulation, is doxorubicin hydrochloride encapsulated in
liposomes with surface-
bound methoxypolyethylene glycol (MPEG). This process is known as
pegylation and protects liposomes
from detection by the mononuclear phagocyte system (MPS), which
increases blood circulation time.
Each CAELYX
®
vial contains 2 mg/ml doxorubicin hydrochloride in a pegylated
liposomal formulation and
delivers 10 ml (20 mg) or 25 ml (50 mg) in a concentrate for infusion
for single intravenous use and is
presented as a sterile, translucent, red suspension.
For excipients, see Section Pharmaceutical Particulars
PHARMACEUTICAL FORM
CAELYX
®
is a sterile, translucent, red liposomal dispersion, concentrate for
intravenous infusion only.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
group:
Cytotoxic
agents
(anthracyclines
and
related
substances),
ATC
code:
L01DB01.
The active ingredient of CAELYX
®
is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic
obtained from Streptomyces peucetius var. caesius. CAELYX
®
is a long-circulating pegylated liposomal
formulation of doxorubicin HCl that provides greater concentration of
doxorubicin in Kaposi’s sarcoma
tumors than in normal skin. Pegylated liposomes contains
surface-grafted segments of the hydrophilic
polymer methoxypolyethylene glycol (MPEG). These linear MPEG groups
extend from the liposome surface
creating a protective coating that reduces interactions between the
lipid bilayer membrane and the plasma
components. This allows the CAELYX
®
liposomes to circulate for prolonged periods in the blood stream.
Pegylated liposomes are small enough (average diameter of
approximately 100 nm) to
pass intact
(extravasate) through defective blood vessels supplying tumors.
Evidence of penetration of