Taxotere Concentrate for Solution for Infusion 80mg4ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Docetaxel trihydrate 85.36mg/4ml eqv Docetaxel

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

L01CD02

Dosage:

80mg/4ml

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Docetaxel trihydrate 85.36mg/4ml eqv Docetaxel 80mg/4ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

2012-02-16

Patient Information leaflet

1. NAME OF THE MEDICINAL PRODUCT
TAXOTERE 80 mg/4 ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel as trihydrate.
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Excipients:
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer
TAXOTERE is indicated for the treatment of patients with locally
advanced or metastatic breast carcinoma. Taxotere in combination with
doxorubicin and cyclophosphamide is indicated for the adjuvant
treatment of patients with operable node-positive breast cancer.
Non-small cell lung cancer
TAXOTERE is indicated for the treatment of patients with locally
advanced or metastatic non-small cell lung cancer.
OVARIAN CANCER:
TAXOTERE is indicated for the treatment of patients with metastatic
carcinoma of the ovary after failure of firstline or subsequent
chemotherapy.
Prostate cancer
TAXOTERE in combination with prednisone or prednisolone is indicated
for the treatment of patients with hormone refractory metastatic
prostate cancer.
Gastric adenocarcinoma
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated
for the treatment of patients with metastatic gastric adenocarcinoma,
including adenocarcinoma of the gastroesophageal junction, who have
not received prior chemotherapy for metastatic disease.
Head and neck cancer
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated
for the induction treatment of patients with locally advanced squamous
cell carcinoma of the head and neck.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of docetaxel should be confined to units specialised in the
administration of cytotoxic chemotherapy and it should only be
administered under the supervision of a physician q

Summary of Product characteristics

SG/TAX/0623/SmPC1222
1
1. NAME OF THE MEDICINAL PRODUCT
TAXOTERE 20 mg/1 ml concentrate for solution for infusion
TAXOTERE 80 mg/4 ml concentrate for solution for infusion
2. 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.
Excipient with known effect:
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395
mg).
For the full list of excipients, see section 6.1.
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.
Excipient with known effect:
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer
TAXOTERE is indicated for the treatment of patients with locally
advanced or metastatic breast
carcinoma. 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 5.1).
Non-small cell lung cancer
TAXOTERE is indicated for the treatment of patients with locally
advanced or metastatic non-
small cell lung cancer.
Ovarian cancer
TAXOTERE is indicated for the treatment of patients with metastatic
carcinoma of the ovary after
failure of first line or subsequent chemotherapy.
Prostate cancer
TAXOTERE in combination with prednisone or prednisolone is indicated
for