DOCETAXEL WINTHROP Concentrate and solvent for solution for infusion 20mg/0.5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DOCETAXEL, TRIHYDRATE

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

L01CD02

Dosage:

0.020g / 0.5ml

Pharmaceutical form:

INJECTION

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Aventis Pharma, Dagenham (Concentrate: bulk, filling, packing & labelling)

Authorization date:

2007-10-26

Patient Information leaflet

 
1. 
NAME OF THE MEDICINAL PRODUCT 

DOCETAXEL WINTHROP 20 mg concentrate and solvent for solution for
infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Single-dose vials of DOCETAXEL WINTHROP 20 mg concentrate for
solution for infusion 
contain docetaxel which is a trihydrate corresponding to 20 mg of
docetaxel (anhydrous). 
The viscous solution contains 40 mg/ml docetaxel (anhydrous). 

For excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Concentrate and solvent for solution for infusion. 
The concentrate for solution for infusion is a clear viscous, yellow
to brown-yellow solution. 
The solvent is a colourless solution. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

BREAST CANCER: DOCETAXEL WINTHROP is indicated for the treatment of
patients with 
locally advanced or metastatic breast carcinoma. Docetaxel Winthrop 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: DOCETAXEL WINTHROP is indicated for the
treatment of 
patients with locally advanced or metastatic non-small cell lung
cancer. 

OVARIAN CANCER: DOCETAXEL WINTHROP is indicated for
the treatment of patients with 
metastatic carcinoma of the ovary after failure of first-line
or subsequent chemotherapy. 

PROSTATE CANCER: DOCETAXEL WINTHROP in combination with prednisone
or prednisolone 
is indicated for the treatment of patients with hormone refractory
metastatic prostate cancer. 

GASTRIC ADENOCARCINOMA: DOCETAXEL WINTHROP (docetaxel) 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 

DOCETAXEL WINTHROP (docetaxel) in combination with cisplatin and
5-fluorouracil is 
ind