Midazolam APOTEX midazolam 5mg/5mL solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
midazolam
Available from:
Apotex Pty Ltd
INN (International Name):
Midazolam
Authorization status:
Registered
Patient Information leaflet
MIDAZOLAM APOTEX
SOLUTION FOR INJECTION
_Midazolam_
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 midazolam. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about being
given this 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 WITH YOU.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
MIDAZOLAM APOTEX solution
for injection. It contains the active
ingredient midazolam.
Midazolam may be injected as a
sedative during some short medical
procedures.
Midazolam may be given to you by
injection before an operation to
produce sleepiness or drowsiness and
to relieve anxiety.
If you are in an intensive care unit,
you may receive an infusion of
midazolam over several hours or
days as a sedative.
_HOW IT WORKS_
Midazolam belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are thought to work
by their action on brain chemicals.
Midazolam can cause sedation,
hypnosis, amnesia and/or
anaesthesia, depending on the dose.
Midazolam is only given by a doctor
trained to use this medicine. If you
will be receiving midazolam during
surgery, your doctor will give you
the medicine and closely follow your
progress.
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.
This medicine is available only with
a doctor's prescription.
As with o
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –MIDAZOLAM
APOTEX (MIDAZOLAM)
1
NAME OF THE MEDICINE
Midazolam
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each ampoule contains 1 mg/mL or 5 mg/mL of midazolam as the active
ingredient. In
addition, each ampoule contains the following inactive ingredients:
sodium chloride,
hydrochloric acid (to produce hydrochloride) and sodium hydroxide in
water for injection to
adjust the pH.
1mg/mL Solution for Injection
Clear colourless to pale yellow solution.
AUST R 217663
5mg/mL Solution for Injection:
Clear colourless to pale yellow solution.
AUST R 217657, AUST R 217658, AUST R 217659
Not all strengths, pack types and/or pack sizes may be available.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
IV as an agent for conscious sedation prior to short surgical,
diagnostic, therapeutic or
endoscopic
procedures,
such
as
bronchoscopy,
gastroscopy,
cystoscopy,
coronary
angiography and cardiac catheterisation, either alone or in
conjunction with a narcotic;
•
IV for induction of anaesthesia, preliminary to administration of
other anaesthetic agents. With
the use of a narcotic premedicant, induction of anaesthesia can be
attained with a narrower
dose range and in a shorter period of time.
•
IV for sedation in intensive care units; intermittent administration
or continuous infusion.
•
IM
for
preoperative
sedation
(induction
of
sleepiness
or
drowsiness
and
relief
of
apprehension) and to impair memory of perioperative events.
4.2
DOSE AND METHOD OF ADMINISTRATION
Midazolam APOTEX Solution for Injection is intended for intravenous
and intramuscular
administration.
Dosage should be individualised and drug should be administered
slowly. Lower doses may
be required in elderly or debilitated patients or in patients with
hepatic or renal insufficiency.
Because serious and life-threatening cardio-respiratory adverse events
have been reported,
provision for monitoring, detection and correction of these reactions
must be made for every
patient to whom midazolam inj
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