TASIGNA

Country: Ինդոնեզիա

language: ինդոնեզերեն

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

units_in_package:

DUS, 7 BLISTER@ 4 KAPSUL

authorization_date:

2022-06-04

SPC

TAXOL®
PACLITAXEL INJECTION
TAXOL
® 6 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Taxol
®
6 mg/ml, concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paclitaxel: 6 mg per 1 ml of concentrate for solution for infusion.
A vial of 5 ml contains 30 mg of paclitaxel.
A vial of 16.7 ml contains 100 mg of paclitaxel.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Taxol
®
is a clear, colourless to slightly yellow viscous solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TAXOL is indicated for the treatment of the following:
OVARIAN CARCINOMA
·
First-line therapy in combination with a platinum compound for the
treatment of
advanced metastatic carcinoma of the ovary.
·
Second-line therapy for the treatment of advanced metastatic carcinoma
of ovary.
BREAST CARCINOMA
·
Adjuvant treatment of node-positive breast cancer administered
sequentially to
standard combination therapy.
·
Therapy after relaps within 6 months of adjuvant therapy. Prior
therapy should have
included an anthracycline unless clinically contraindicated.
·
Second-line therapy after failure of combination chemotherapy for
metastatic disease.
Prior therapy should have included an anthracycline unless clinically
contraindicated.
·
For the treatment of advanced or metastatic breast cancer in
combination with
trastuzumab
in
patients
who
over
express
HER-2
at
3+
level
as determined
by
immunohistochemistry or FISH +
NON-SMALL CELL LUNG CARCINOMA
·
First-line therapy in combination with a platinum compound for the
treatment of non-
small cell carcinoma of the lung in patients who are not candidates
for potentially
curative surgery and/or radiation therapy.
KAPOSI’S SARCOMA
·
Second-line treatment of AIDS-related Kaposi’s Sarcoma
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
All patients must be premedicated with corticosteroids,
antihistamines, and H2 antagonists prior
to Taxol, e.g.
DRUG
DOSE
ADMINISTRATION PRIOR TO