AS-Docetaxel

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Docetaxel 40 mg/mL;  
Available from:
Viatris Limited
INN (International Name):
Docetaxel 40 mg/mL
Dosage:
40 mg/mL
Pharmaceutical form:
Injection with diluent
Composition:
Active: Docetaxel 40 mg/mL   Excipient: Citric acid Nitrogen Polysorbate 80 Ethanol Nitrogen Water for injection
Prescription type:
Prescription
Manufactured by:
Laurus Labs Limited
Therapeutic indications:
Head and Neck Cancer Docetaxel, in combination with cisplatin and fluorouracil is indicated in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Product summary:
Package - Contents - Shelf Life: Combination pack, 1 x Docetaxel concentrate 0.5 mL with 1 x 1.8 mL diluent - 2.3 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Combination pack, 1 x Docetaxel concentrate 2 mL with 1 x 7.1 mL diluent - 9.1 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Docetaxel: Type 1, 5 mL capacity containing 0.5 mL, rubber stopper, flip off cap and aluminium seal - 0.5 mL - 24 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at or below 25°C protect from light - Vial, glass, Diluent: Type 1, 5 mL capacity containing 1.8 mL, rubber stopper, flip off cap and aluminium seal - 1.8 mL - 24 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at or below 25°C protect from light - Vial, glass, Docetaxel: Type 1, 10 mL capacity containing 2 mL, rubber stopper, flip off cap and aluminium seal - 2 mL - 24 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at or below 25°C protect from light - Vial, glass, Diluent: Type 1, 10 mL capacity containing 7.1 mL, rubber stopper, flip off cap and aluminium seal - 7.1 mL - 24 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at or below 25°C protect from light
Authorization number:
TT50-8777/1
Authorization date:
2011-03-11

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