APO-Flumazenil flumazenil 0.5 mg/ 5 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flumazenil, Quantity: 0.1 mg/mL

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Flumazenil

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; glacial acetic acid; sodium chloride; disodium edetate; water for injections

Administration route:

Intravenous

Units in package:

5 x 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Flumazenil is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). Hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of flumazenil. Not to be used in outpatients or short stay patients. Not to be used as a diagnostic.

Product summary:

Visual Identification: A clear and colourless solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-02-15