DOXLOX Doxorubicin HCl Liposome Injection Concentrate for Solution for Infusion 2 mgml

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

DOXORUBICIN HYDROCHLORIDE

متاح من:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (الاسم الدولي):

DOXORUBICIN HYDROCHLORIDE

الوحدات في الحزمة:

20mg/10 ml; 50mg/25 ml

المصنعة من قبل:

Natco Pharma Ltd.

نشرة المعلومات

Not Applicable

خصائص المنتج

DOXLOX
DOXORUBICIN HCL LIPOSOME INJECTION CONCENTRATE FOR SOLUTION FOR
INFUSION 2 MG/ML
(PEGYLATED LIPOSOMAL FORMULATION)
COMPOSITION:
Each ml of Doxlox contains 2 mg doxorubicin hydrochloride in a
pegylated liposomal formulation.
PRODUCT DESCRIPTION:
Doxorubicin hydrochloride liposome injection is a translucent, red
liposomal dispersion.
DESCRIPTION AFTER DILUTION: A translucent red liposomal dispersion.
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
Doxorubicin is indicated:
-
As monotherapy for patients with metastatic breast cancer
-
For treatment of advanced ovarian cancer in women who have failed a
rst-line platinum-based chemotherapy regimen.
-
In combination with bortezomib for the treatment of progressive
multiple myeloma in patients who have received at least one prior
therapy and who have already undergone or are unsuitable for bone
marrow transplant.
-
For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with
low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous
or visceral disease.
Doxorubicin may be used as rst-line systemic chemotherapy, or as
second line chemotherapy in AIDS-KS patients with disease that has
progressed with, or in patients intolerant to, prior combination
systemic chemotherapy comprising at least two of the following agents:
a vinca alkaloid, bleomycin and standard doxorubicin (or other
anthracycline).
POSOLOGY AND METHOD OF ADMINISTRATION
Doxorubicin should only be administered under the supervision of a
qualied oncologist specialised in the administration of cytotoxic
agents.
Doxorubicin exhibits unique pharmacokinetic properties and must not be
used interchangeably with other formulations of doxorubicin
hydrochloride.
Posology
_Breast cancer/Ovarian cancer_
2
Doxorubicin is administered intravenously at a dose of 50 mg/m once
every 4 weeks for as long as the disease does not progress and the
patient continues to tolerate treatment.
_Multiple myeloma_
Doxorubicin is administered at 30 mg/m² on day 4 of the bortezomib 3
week regimen as a 1 hour