ANEXATE INJECTION 0.5 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FLUMAZENIL

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

V03AB25

Dosage:

0.5 mg/5 ml

Pharmaceutical form:

INJECTION

Composition:

FLUMAZENIL 0.5 mg/5 ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CENEXI SAS

Authorization status:

ACTIVE

Authorization date:

1988-05-25

Patient Information leaflet

Apr 2014 

Ro 15-1788 

  Anexate 
Apr 2014 
Production Information FE/English 
1
ANEXATE®  
Flumazenil 

1. DESCRIPTION 
1.1 
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
Benzodiazepine antagonist. 
ATC code: V03AB25.  

1.2 
TYPE OF DOSAGE FORM 
Ampoules. 

1.3 ROUTE 
OF 
ADMINISTRATION 
Intravenous injection. 

1.4 
STERILE / RADIOACTIVE STATEMENT 
Sterile product. 

1.5 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active ingredient: flumazenil. 
Ampoules containing 0.5 mg active ingredient in 5 ml aqueous 
solution and 1 mg active ingredient in 10 ml aqueous solution. 

2. CLINICAL

PARTICULARS 
2.1 THERAPEUTIC 
INDICATION(S) 
Anexate is indicated for complete or partial reversal of the
central 
sedative effects of benzodiazepines. It is therefore used in
anesthesia 
and intensive care in the following indications: 

_In anesthesia  _
 Termination of general anesthesia induced
and maintained with 
benzodiazepines in inpatients. 
 Reversal of benzodiazepine sedation in short diagnostic and 
therapeutic procedures in both inpatients and outpatients. 

_In intensive care  _
 Anexate provides a diagnosis of benzodiazepine intoxication
or 
rules out such intoxication.  
  Anexate may also be used for specific reversal of the
central effects 
of benzodiazepines in drug overdose (return to spontaneous 
respiration and consciousness in order to render intubation 
unnecessary or allow extubation). 

2.2 DOSAGE 
AND 
ADMINISTRATION 
Anexate is recommended for intravenous use only and should be 
administered by an anesthesiologist or experienced physician.  
For handling solution, see 4.2 Special Instructions for
Use, Handling 
and Disposal.  
Dosage should be titrated for the intended effect. Since the
duration of 
action of some benzodiazepines may exceed that of Anexate, 
repeated doses may be required if sedation recurs following 
awakening.

Summary of Product characteristics

March 2019
March 2019
1
Production Information FE/English
Ro 15-1788
ANEXATE
®
Flumazenil
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Benzodiazepine antagonist.
ATC code: V03AB25.
1.2
TYPE OF DOSAGE FORM
Ampoules.
1.3
ROUTE OF ADMINISTRATION
Intravenous injection.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: flumazenil.
Ampoules
containing
0.5
mg
active
ingredient
in
5
ml
aqueous
solution and 1 mg active ingredient in 10 ml aqueous solution.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Anexate is indicated for complete or partial reversal of the central
sedative effects of benzodiazepines. It is therefore used in
anesthesia
and intensive care in the following indications:
_In anesthesia_

Termination of general anesthesia induced and maintained with
benzodiazepines in inpatients.

Reversal of benzodiazepine sedation in short diagnostic and
therapeutic procedures in both inpatients and outpatients.
_In intensive care_

Anexate provides a diagnosis of benzodiazepine intoxication or rules
out such intoxication.

Anexate may also be used for specific reversal of the central effects
of
benzodiazepines in drug overdose (return to spontaneous respiration
and consciousness in order to render intubation unnecessary or allow
extubation).
2.2
DOSAGE AND ADMINISTRATION
Anexate is recommended for intravenous use only and should be
administered by an anesthesiologist or experienced physician.
For handling solution, see 4.2 Special Instructions for Use, Handling
and Disposal.
Dosage should be titrated for the intended effect. Since the duration
of
action of some benzodiazepines may exceed that of Anexate, repeated
doses may be required if sedation recurs following awakening.
_In anesthesia: _ The recommended initial dose of Anexate is 0.2 mg
administered
i.v.
over
15
seconds.
If
the
desired
degree
of
consciousness is not obtained within 60 seconds, a second dose of
0.1 mg can be injected; this may be repeated at 60-sec