Taxotere

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Docetaxel 40 mg/mL

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Docetaxel 40 mg/mL

Dosage:

40 mg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Docetaxel 40 mg/mL Excipient: Polysorbate 80 Ethanol Water for injection

Units in package:

Combination pack, 80mg + 2mL diluent, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Metastatic Breast Cancer TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Product summary:

Package - Contents - Shelf Life: Combination pack, 80mg + 2mL diluent - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. between + 2°C and +25°C 4 hours reconstituted stored at or below 25°C protect from light. Do not freeze - Combination pack, 20mg + 0.5mL diluent - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. between + 2°C and +25°C 4 hours reconstituted stored at or below 25°C protect from light. Do not freeze - Vial, glass, - Alcohol/Water solvent - 0.5 mL -   - Vial, glass, - Alcohol/Water solvent - 2 mL -   - Vial, glass, - 20 mg - 24 months from date of manufacture stored at or below 25°C protect from light. between + 2°C and +25°C - Vial, glass, - 80 mg - 36 months from date of manufacture stored at or below 25°C protect from light. between + 2°C and +25°C

Authorization date:

1994-08-15

Summary of Product characteristics

New Zealand Data Sheet
November 2017
taxotere-2-vial-ccdsv34-dsv12-30nov17
Page 1
DATA SHEET
1
PRODUCT NAME
Taxotere 40mg/mL concentrate for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAXOTERE CONCENTRATED INJECTION AND DILUENT
Single-dose vials of TAXOTERE concentrated injection containing 20 or
80mg of docetaxel
(anhydrous), in 0.5 or 2.0mL polysorbate 80, respectively. The sterile
pyrogen-free viscous
solution contains 40mg/mL docetaxel (anhydrous).
Each mL of docetaxel solution contains 40mg docetaxel anhydrous and
1040mg polysorbate 80.
The corresponding vials of diluent for TAXOTERE 20mg and 80mg
concentrated injections
contain 1.98 and 7.33mL of ethanol, respectively in water for
injections.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
TAXOTERE concentrate for infusion to be diluted is supplied in
single-dose vials as a sterile
pyrogen-free non-aqueous clear yellow to brown yellow viscous solution
with the accompanying
sterile solvent (13% ethanol in water for injections).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BREAST CANCER
METASTATIC BREAST CANCER
TAXOTERE is indicated for the treatment of patients with locally
advanced or metastatic breast
cancer in whom previous chemotherapy has failed.
New Zealand Data Sheet
November 2017
taxotere-2-vial-ccdsv34-dsv12-30nov17
Page 2
TAXOTERE in combination with capecitabine is indicated for the
treatment of patients with
locally advanced or metastatic breast cancer
after failure of prior anthracycline containing
chemotherapy.
ADJUVANT TREATMENT OF BREAST CANCER
TAXOTERE
in
combination
with
doxorubicin
and
cyclophosphamide
is
indicated
for
the
adjuvant treatment of patients with operable node-positive breast
cancer.
Doxorubicin and cyclophosphamide followed by TAXOTERE in combination
with trastuzumab
(AC-TH) is indicated for the adjuvant treatment of patients with
operable breast cancer whose
tumours overexpress HER2.
TAXOTERE
in
combination
with
carboplatin
and
trastuzumab
(TCH)
is
indicated
for
the
adjuvant treatment of pat