Docetaxel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Docetaxel trihydrate 100.71mg equivalent to anhydrous docetaxel 80 mg

Available from:

REX Medical Ltd

INN (International Name):

Docetaxel trihydrate 100.71 mg (equivalent to anhydrous docetaxel 80 mg)

Dosage:

80 mg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Docetaxel trihydrate 100.71mg equivalent to anhydrous docetaxel 80 mg Excipient: Citric acid Polysorbate 80 Ethanol Water for injection

Units in package:

Vial, glass, Diluent, 6 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel 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. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours express HER2 and who previously have not received chemotherapy for metastatic disease.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Diluent - 6 mL - 24 months from date of manufacture - Vial, glass, concentrate solution - 80 mg - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2006-06-23