Taxotere 20mg1ml concentrate for solution for infusion

国: マレーシア

言語: 英語

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

有効成分:

DOCETAXEL TRIHYDRATE

から入手可能:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN（国際名）:

DOCETAXEL TRIHYDRATE

パッケージ内のユニット:

4ml mL; 1ml mL

製:

Sanofi-Aventis Deutschland GmbH

製品の特徴

1
MY/TAX/Jun 2023/SmPC1222
TAXOTERE 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAXOTERE 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION:
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipients with known effect:
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395
mg).
For a full list of excipients, see section
_List of Excipients _
TAXOTERE 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Excipients with known effect:
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g)
For a full list of excipients, see section
_List of Excipients._
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Breast Cancer
TAXOTERE in combination with doxorubicin and cyclophosphamide is
indicated for the
adjuvant treatment of patients with:
•
operable node-positive breast cancer.
•
operable node-negative breast cancer.
For patients with operable node-negative breast cancer, adjuvant
treatment should be
restricted
to
patients
eligible
to
receive
chemotherapy
according
to
internationally
established
criteria
for
primary
therapy
of
early
breast
cancer
(see
section
_Pharmacodynamic Properties_
).
TAXOTERE in combination with doxorubicin is indicated for the
treatment of patients
with locally advanced or metastatic breast cancer who have not
previously received
cytotoxic therapy for this condition.
TAXOTERE in combination with capecitabine is indicated for the
treatment of patients
with locally advanced or metastatic breast cancer after failure of
cytotoxic chemotherapy.
Previous therapy should have included an anthracycline.
2
MY/TAX/Jun 2023/SmPC1222
TAXOTERE
monotherapy
is
indicated
for
the
treatment
of
patients
with
loca