Flumazenil Kabi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flumazenil 0.1 mg/mL

Available from:

Fresenius Kabi New Zealand Limited

Dosage:

1 mg/10mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Flumazenil 0.1 mg/mL Excipient: Acetic acid Disodium edetate dihydrate Nitrogen Sodium chloride Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

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).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10 mL colourless type 1 - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 10 mL colourless type 1 - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2017-04-06

Patient Information leaflet

CMI for Flumazenil Kabi
Filename: CMI-clean
Page 1 of 2
FLUMAZENIL KABI
Flumazenil Kabi Solution for Injection
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Flumazenil
Kabi
injection. It does not contain all the
available information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
being
given
Flumazenil
Kabi
against
the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUMAZENIL KABI
IS USED FOR
Flumazenil Kabi is used to reverse
benzodiazepine
overdose,
both
suspected and known.
It is given to arouse people after
surgery
or
benzodiazepine
overdose.
Your doctor may have prescribed
Flumazenil
Kabi
for
another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY FLUMAZENIL KABI
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
FLUMAZENIL KABI
WHEN
YOU
MUST
NOT
BE
GIVEN IT
FLUMAZENIL
KABI
MUST
NOT
BE
GIVEN IF YOU HAVE ANY ALLERGIES TO
•
Any
medicine
containing
flumazenil or
•
Any of the ingredients listed at
the end of this leaflet
YOU
MUST
NOT
BE
GIVEN
THIS
MEDICINE
IF
YOU
ARE
TAKING
A
BENZODIAZEPINE FOR CONTROL OF A
POTENTIALLY
LIFE-THREATENING
CONDITION.
BEFORE YOU ARE GIVEN IT
Your doctor must know about all
the following before you are given
Flumazenil Kabi.
You must tell your doctor if:
•
YOU ARE ALLERGIC TO ANY OTHER
MEDICINES
OR
ANY
OTHER
SUBSTANCES
SUCH
AS
FOODS,
PRESERVATIVES OR DYES
•
YOU SUFFER FROM EPILEPSY
•
YOU HAVE SEVERE LIVER DISEASE
•
YOU
SUFFER
FROM
PANIC
DISORDER
•
YOU
HAVE
BEEN
TAKING
HIGH
DOSES
OF
BENZODIAZEPINES
AND/OR YOU HAVE BEEN TAKING
BENZODIAZEPINES
FOR
A
LONG
TIME.
If you have not told your doctor
about any of the above, tell him/her
before
you
are
given
Flumazenil
Kabi.
TAKING OTHER MEDICINES
YOU MUST TELL YOUR DOCTO

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME (STRENGTH PHARMACEUTICAL FORM)
Flumazenil Kabi 0.1 mg/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 0.1 mg flumazenil.
1 ampoule with 5 mL contains 0.5 mg flumazenil.
1 ampoule with 10 mL contains 1 mg flumazenil.
For the full list of excipients, see SECTION 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Flumazenil Kabi Injection is a colourless to almost colourless clear
liquid. The
active ingredient of flumazenil belongs to the chemical group of 1,2-
imidazo
benzodiazepines and is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-
4H-imidazo
[1,5-a] [1,4] benzodiazepine -3- carboxylate (flumazenil). It has a
molecular
weight of 303.3.
2
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
• Flumazenil Injection 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).
3
4.2 DOSE AND METHOD OF ADMINISTRATION
Flumazenil Injection is recommended for intravenous (IV) use only and
should
be administered by an anaesthesiologist or ex