AS-Docetaxel

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Docetaxel 40 mg/mL;  

MAH:

Viatris Limited

INN:

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_indication:

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.

leaflet_short:

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_date:

2011-03-11