DBL™ Flumazenil

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Flumazenil 0.5mg

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Flumazenil 0.5 mg

Dosering:

0.5 mg/5mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Flumazenil 0.5mg Excipient: Acetic acid Disodium edetate dihydrate Sodium chloride Sodium hydroxide Water for injection

Enheder i pakken:

Ampoule, glass, Type I clear one point cut 5 mL ampoule pack of 5, 25 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Perrigo API Ltd

Terapeutiske indikationer:

Latest Regulatory Activity

Produkt oversigt:

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

Autorisation dato:

2006-05-26

Produktets egenskaber

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