DBL FLUMAZENIL INJECTION flumazenil 0.5mg/5mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flumazenil, Quantity: 0.5 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Flumazenil

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

5 mL ampoule, 5 pack

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: Ampoule containing a clear colourless solution, free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-09-06

Patient Information leaflet

DBL™ FLUMAZENIL INJECTION
1
DBL™ FLUMAZENIL
INJECTION
_flumazenil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL™ Flumazenil
Injection (flumazenil). 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 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 DBL FLUMAZENIL
INJECTION IS USED FOR
DBL Flumazenil Injection is used to
reverse benzodiazepine overdose,
both suspected and known.
It is given to arouse people after
surgery involving benzodiazepine
when required.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
It is available only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DBL FLUMAZENIL
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN DBL
FLUMAZENIL INJECTION IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
flumazenil
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
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
DBL FLUMAZENIL INJECTION.
YOU MUST TELL YOUR DOCTOR IF:
•
you are allergic to any other
substances such as foods,
preservatives or dyes
•
you suffer from epilepsy
•
you have liver disease
•
you suffer from panic disorder
•
you have taken high doses of
benzodiazepines and/or you have
been tak

Summary of Product characteristics

Version:pfpflumi10920
Supersedes: pfpflum10519
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ FLUMAZENIL INJECTION (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
DBL™
Flumazenil Injection is a colourless to almost colourless clear
liquid, available as
0.5 mg/5 mL, 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
DOSAGE
REVERSAL OF BENZODIAZEPINE EFFECTS AT THERAPEUTIC DOSES (ANAESTHESIA
OR SEDATION)
The recommended initial dose is 0.2 mg administered intravenously
within 15 seconds. If the
desired degree of consciousness is not obtained within 60 seconds
following the first
intravenous administration, a second dose of 0.1 mg can be injected
and this may be repeated
at 60 second intervals where necessary, up to a total dose of 1 mg.
The usual dose is 0.3 to
0.6 mg.
CHILDREN > 1 YEAR OF AGE
(see
Section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
)
The recommended initial dose is 0.01 mg/kg (or up to 0.2 mg, whichever
is lower) administered
intravenously over 15 seconds. If the desired level of consciousness
is not obtained after
waiting for 60 seconds, further injections of 0.01 mg/kg (or up to 0.2
mg, whichever is lower)
can be administered and repeated at 60 second intervals where
necess