Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Flumazenil 0.5mg
Pfizer New Zealand Limited
Flumazenil 0.5 mg
0.5 mg/5mL
Solution for injection
Active: Flumazenil 0.5mg Excipient: Acetic acid Disodium edetate dihydrate Sodium chloride Sodium hydroxide Water for injection
Ampoule, glass, Type I clear one point cut 5 mL ampoule pack of 5, 25 mL
Prescription
Prescription
Perrigo API Ltd
Latest Regulatory Activity
Package - Contents - Shelf Life: Ampoule, glass, Type I clear one point cut 5 mL ampoule pack of 5 - 25 mL - 24 months from date of manufacture stored at or below 25°C
2006-05-26
Version: pfdflumi10720 Supercedes: Version 4.0 Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Flumazenil Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ampoules contain 0.1 mg/mL flumazenil in aqueous solution (for intravenous administration) and also the following ingredients: disodium edetate, acetic acid, sodium chloride, sodium hydroxide in water for injections adjusted to pH 4.0. DBL Flumazenil Injection is available as 0.5 mg/5 mL and 1 mg/10 mL ampoules. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Flumazenil Injection is a colourless to almost colourless clear liquid, adjusted to pH 4.0. Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Flumazenil Injection 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DBL Flumazenil Injection should be administered intravenously by an anaesthetist or experienced physician. Dosage should be titrated for the intended effect. Since the duration of action of some benzodiazepines may exceed that of DBL Flumazenil Injection, repeated doses may be required if sedation recurs following awakening. The use of DBL Flumazenil Injection should be balanced against the risk of precipitating withdrawal symptoms (see section 4.4). The desirability of retaining a degree of sedation in the early postoperative period should be considered. DBL Flumazenil Injection may be diluted in glucose 5% in water or 0.9% NaCl for infusion and may also be used concurrently with other resuscitative procedures. In order to reduce microbial contamination hazards, infusion should be commenced as soon as practicable after Version: pfdflumi10720 Supercedes: Version 4.0 Page 2 Olvassa el a teljes dokumentumot