DOCETAXEL SANDOZ CONCENTRATE FOR SOLUTION FOR INFUSION 10MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Docetaxel

Available from:

SANDOZ SINGAPORE PTE. LTD.

ATC code:

L01CD02

Dosage:

10mg/ml

Pharmaceutical form:

INJECTION, SOLUTION, CONCENTRATE

Composition:

Docetaxel 10mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Fareva Unterach GmbH

Authorization status:

ACTIVE

Authorization date:

2014-06-25

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Sandoz Concentrate for Solution for Infusion 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the concentrate for solution for infusion contains 10 mg
docetaxel.
Each vial of 2 ml contains 20 mg docetaxel anhydrous (10 mg/ml).
Each vial of 8 ml contains 80 mg docetaxel anhydrous (10 mg/ml).
Each vial of 16 ml contains 160 mg docetaxel anhydrous (10mg/ml).
Excipient: Each single-dose vial of concentrate for solution contains
27% (w/w) ethanol 96%
_. _
_ _
_For a full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to pale
_, _
yellow solution; pH 3.0 - 4.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel is indicated for the treatment of patients with locally
advanced or metastatic breast carcinoma.
Docetaxel 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
Docetaxel is indicated for the treatment of patients with locally
advanced or metastatic non-small cell
lung cancer.
Ovarian cancer
Docetaxel is indicated for the treatment of patients with metastatic
carcinoma of the ovary after failure of first
line or subsequent chemotherapy.
Prostate cancer
Docetaxel in combination with prednisone or prednisolone is indicated
for the treatment of patients with
hormone refractory metastatic prostate cancer.
Gastric adenocarcinoma
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
rece