MIDAZOLAM AN Midazolam (as hydrochloride) 5 mg/5 mL solution for injection ampoules
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
13-07-2018
Summary of Product characteristics
(SPC)
13-07-2018
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
midazolam
Available from:
Accord Healthcare Pty Ltd
INN (International Name):
Midazolam
Authorization status:
Registered
Patient Information leaflet
MIDAZOLAM AN
Midazolam injection, 5 mg/5 mL, 5 mg/1 mL, 15 mg/3 mL and 50 mg/10 mL
CONSUMER MEDICINE INFORMATION
Version 3.0
Page 1 of 4
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MIDAZOLAM AN.
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 using
MIDAZOLAM AN 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 MIDAZOLAM
AN IS USED FOR
MIDAZOLAM AN may be
injected as a sedative during
some short medical procedures.
MIDAZOLAM AN 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 AN over
several hours or days as a
sedative.
MIDAZOLAM AN belongs to a
group of medicines called
benzodiazepines. They are
thought to work by their action
on brain chemicals.
MIDAZOLAM AN can cause
sedation, hypnosis, amnesia
and/or anaesthesia, depending on
the dose.
Your doctor, however, may have
prescribed MIDAZOLAM AN
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
MIDAZOLAM AN HAS BEEN
PRESCRIBED FOR YOU.
MIDAZOLAM AN is only given
by a doctor trained to use this
medicine.
If you will be receiving
MIDAZOLAM AN during
surgery, your doctor will give
you the medicine and closely
follow your progress.
This medicine is available only
with a doctor's prescription.
BEFORE YOU RECEIVE
MIDAZOLAM AN
_DO NOT USE MIDAZOLAM AN _
_if: _
_ _
•
YOU HAVE HAD AN ALLERGIC
REACTION TO MIDAZOLAM
AN, ANY OTHER
BENZODIAZEPINE MEDICINE,
OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET
•
YOU HAVE SEVERE MUSCLE
WEAKNESS, ALSO KNOWN AS
MYASTHENIA GRAVIS
•
YOU HAVE A CONDITION CALLED
ACUTE NARROW ANGLE
GLAUCOMA
•
YOU ARE SUFFERING FROM
SHOCK, COMA OR ACUTE
AL
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Summary of Product characteristics
Page
1
of
15
AUSTRALIAN PRODUCT INFORMATION
MIDAZOLAM AN INJECTION
1
NAME OF THE MEDICINE
Midazolam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam is a benzodiazepine from the imidazobenzodiazepine group. It
is a white or yellowish
crystalline powder, practically insoluble in water, freely soluble in
acetone and alcohol, soluble in
methanol. The free base of the active substance of midazolam is a
lipophilic substance with low
solubility in water. The basic nitrogen in position 2 of the
imidazobenzodiazepine ring enables the active
substance of midazolam to form water soluble salts with acids. These
produce a stable injection solution.
Midazolam AN injection contains midazolam 1 mg/mL or 5 mg/mL (as
hydrochloride).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Midazolam AN injection is a clear, colourless to pale yellow, isotonic
solution. The pH of the
solution is between 2.9 and 3.7.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF 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
be
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