Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DOXORUBICIN HYDROCHLORIDE
SOHO INDUSTRI PHARMASI - Indonesia
DOXORUBICIN HYDROCHLORIDE
2 MG/ML
INFUS
DUS, 1 VIAL @ 10 ML
GLAXOSMITHKLINE MANUFACTURING S.P.A. - Italy
2019-12-04
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 Læs hele dokumentet