New Zealand - English - Medsafe (Medicines Safety Authority)

max health limited - flumazenil 0.1 mg/ml;   - solution for injection - 0.1 mg/ml - active: flumazenil 0.1 mg/ml   excipient: acetic acid disodium edetate 1 n sodium hydroxide solution (adjust the ph to 4.1) nitrogen sodium chloride water for injection - flumazenil is indicated for reversal of the centrally sedative effects of benzodiazepines. it should therefore be used in anaesthesia and intensive care in the following indications: in anaesthesia - termination of general anaesthesia induced and maintained with benzodiazepines in inpatients. - reversal of benzodiazepine sedation in short diagnostic and therapeutic procedures in both inpatients and outpatients. - reversal of paradoxical reactions due to benzodiazepines. in intensive care and in the management of unconsciousness of unknown origin - for the diagnosis and/or management of benzodiazepine overdose due to self-poisoning or accidental overdose. - as a diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other medicines or drugs or brain damage. - flumazenil may also be used for specific reversal of the central effects of benzodiazepines in drug or medicine overdose (return to spontaneous respiration and consciousness in order to render intubation unnecessary or allow extubation).

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - flumazenil 0.1 mg/ml - solution for injection - 0.1 mg/ml - active: flumazenil 0.1 mg/ml excipient: disodium edetate glacial acetic acid sodium chloride sodium hydroxide water for injection - for reversal of the centrally sedative effects of benzodiazepines. it should therefore be used in anaesthesia and intensive care in the following indications: in anaesthesia: -termination of general anaesthesia induced and maintained with benzodiazepines in inpatients. -reversal of benzodiazepine sedation in short diagnostic and therapeutic procedures in both inpatients and outpatients. -reversal of paradoxical reactions due to benzodiazepines. in intensive care and in the management of unconsciousness of unknown origin: -for the diagnosis and/or management of benzodiazepine overdose due to self-poisoning or accidental overdose. -as a diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other medicines or drugs or brain damage. -flumazenil-claris may also be used for specific reversal of the central effects of benzodiazepines in drug or medicine overdose (return to spontaneous respiration and consciousness in order to render intubation unnecessary or allow extubation).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - flumazenil 0,1 mg/ml - solution for injection - 0,1 mg/ml - flumazenil 0.1 mg/ml - flumazenil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - flumazenil 0,1 mg/ml - solution for injection - 0,1 mg/ml - flumazenil 0.1 mg/ml - flumazenil

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - flumazenil, quantity: 1 mg - injection, solution - excipient ingredients: disodium edetate; sodium chloride; water for injections; sodium hydroxide; glacial acetic acid - flumazenil-baxter 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-claris. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - flumazenil 0.1 mg/ml - solution for injection - 1 mg/10ml - active: flumazenil 0.1 mg/ml excipient: acetic acid disodium edetate dihydrate nitrogen sodium chloride sodium hydroxide water for injection - flumazenil injection is indicated for reversal of the centrally sedative effects of benzodiazepines. it should therefore be used in anaesthesia and intensive care in the following indications: in anaesthesia · termination of general anaesthesia induced and maintained with benzodiazepines in inpatients. · reversal of benzodiazepine sedation in short diagnostic and therapeutic procedures in both inpatients and outpatients. · reversal of paradoxical reactions due to benzodiazepines. in intensive care and in the management of unconsciousness of unknown origin · for the diagnosis and/or management of benzodiazepine overdose due to self-poisoning or accidental overdose. · as a diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other medicines or drugs or brain damage. · may also be used for specific reversal of the central effects of benzodiazepines in drug or medicine overdose (return to spontaneous respiration and consciousness in order to render intubation unnecessary or allow extubation).

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - flumazenil - solution for injection - 0.1 milligram(s)/millilitre - antidotes; flumazenil

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - flumazenil - solution for injection - 0.1 mg/ml

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - flumazenil, quantity: 0.5 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; disodium edetate; glacial acetic acid; sodium chloride - flumazenil-baxter 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-claris. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - flumazenil, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; glacial acetic acid; sodium chloride; disodium edetate; water for injections - 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.