FLUMAZENIL KABI flumazenil 1mg/10mL solution for injection ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flumazenil, Quantity: 0.1 mg/mL

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Flumazenil

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; sodium hydroxide; disodium edetate; sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

10, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Flumazenil Kabi 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.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-10-25

Patient Information leaflet

CMI for Flumazenil Kabi
March, 2016
Filename: FluCMI020316-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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FLUMAZENIL KABI
(FLUMAZENIL)
1
NAME OF THE MEDICINE
Flumazenil
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.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for Injection.
Flumazenil Kabi is a colourless to almost colourless clear liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flumazenil Kabi 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
Flumazenil Kabi should be administered intravenously by an
anaesthetist or
experienced physician.
The use of Flumazenil Kabi should be balanced against the risk of
precipitating
withdrawal symptoms (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
The desirability of retaining a degree of sedation in the early
postoperative period should
be considered.
Flumazenil Kabi may be diluted in glucose 5% in water or 0.9% Sodium
Chloride for
infusion and may also be used concurrently with other resuscitative
procedures. To
reduce microbial contamination hazard, use as soon as practicable
after dilution. If
storage is necessary, hold at 2° to 8°C for not more than 24 hours.
Flumazenil Kabi is for use in one patient only. Discard any remaining
contents.
REVERSAL OF BENZODIAZEPINE EFFECTS AT THERAPEUTIC DOSES (ANAESTHESIA
OR SEDATION)
The recommended initial dose is 0.2 mg administered I.V. within 15
seconds. If the
desired degree of consciousness is not obtained within 60 seconds
following the first I.