Flumazenil-Baxter

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flumazenil 0.1 mg/mL

Available from:

Baxter Healthcare Ltd

INN (International Name):

Flumazenil 0.1 mg/mL

Dosage:

0.1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Flumazenil 0.1 mg/mL Excipient: Disodium edetate Glacial acetic acid Sodium chloride Sodium hydroxide Water for injection

Prescription type:

Prescription

Manufactured by:

Hubei Haosun Pharmaceutical Co Limited

Therapeutic indications:

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).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I, 10 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type I, 5mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type I, 10 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type I, 5 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Authorization date:

2015-06-24

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Flumazenil‐Baxter Data Sheet 29 April 2020
Page 1 of 11
Baxter Healthcare Ltd
1 FLUMAZENIL‐BAXTER (0.1mg/mL, solution for injection)
FLUMAZENIL‐BAXTER 0.5mg/5mL solution for injection.
FLUMAZENIL‐BAXTER 1.0mg/10mL solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUMAZENIL‐BAXTER, solution for infusion contains 0.1mg flumazenil
per mL.
One 5mL ampoule contains 0.5mg flumazenil.
One 10mL ampoule contains 1.0mg flumazenil.
Each 1mL of FLUMAZENIL‐BAXTER solution for injection contains
approximately 3.5mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
FLUMAZENIL‐BAXTER is a clear, colourless to almost‐colourless,
sterile solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
FLUMAZENIL‐BAXTER 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‐BAXTER 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).
4.2
Dose and method of administration
_Dosage _
FLUMAZENIL‐BAXTER is recommended for intravenous (IV) use only and
should be administered by