Flumazenil APOTEX flumazenil 0.5 mg/ 5 mL solution for injection ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

flumazenil

Saatavilla:

Apotex Pty Ltd

INN (Kansainvälinen yleisnimi):

Flumazenil

Valtuutuksen tilan:

Registered

Pakkausseloste

FLUMAZENIL APOTEX
SOLUTION FOR INJECTION
_Contains the active ingredient flumazenil_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about flumazenil. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet. You may want to
read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Flumazenil APOTEX solution for
injection. It contains the active
ingredient flumazenil.
It is used to reverse benzodiazepine
overdose, both suspected and known.
It is given to arouse people after
surgery or benzodiazepine overdose.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE THIS MEDICINE IF:
•
YOU ARE TAKING A
BENZODIAZEPINE FOR CONTROL OF A
POTENTIALLY LIFE-THREATENING
CONDITION
•
YOU ARE HYPERSENSITIVE TO, OR
HAVE HAD AN ALLERGIC REACTION TO,
FLUMAZENIL OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include: cough, shortness of
brea

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION – FLUMAZENIL APOTEX
SOLUTION FOR INJECTION (FLUMAZENIL)
1
NAME OF THE MEDICINE
Flumazenil
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Flumazenil is a white or almost white, crystalline powder which is
very slightly soluble in
water, freely soluble in methylene chloride and sparingly soluble in
methanol.
Flumazenil solution for intravenous injection is a clear and
colourless solution, free from
visible particles containing flumazenil, as the active ingredient. In
addition, each solution for
injection ampoule contains the following inactive ingredients:
disodium edetate, glacial acetic
acid, sodium chloride, sodium hydroxide in water for injections
adjusted to pH 4.0.
FLUMAZENIL APOTEX 0.5MG/5 ML SOLUTION FOR INJECTION:
A clear and colourless sterile solution, free from visible particles
(AUST R 236672)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flumazenil 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 should be administered intravenously by an anaesthetist or
experienced
physician.
The use of flumazenil 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 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
preparation. Infusion should be completed within 24 hours of
preparation and any residue
disca