Midazolam-Baxter midazolam (as hydrochloride) 5mg/1 mL 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, Quantity: 5 mg/mL
Available from:
Baxter Healthcare Pty Ltd
INN (International Name):
Midazolam
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections; nitrogen
Administration route:
Intravenous, Intramuscular
Units in package:
1 mL, packs of 10 ampoules, 1 mL, packs of 5 ampoules, 1 mL, packs of 25 ampoules
Prescription type:
(S4) Prescription Only Medicine
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.
Product summary:
Visual Identification: Clear, colourless to pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-10-08
Patient Information leaflet
MIDAZOLAM-CLARIS
_Midazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Midazolam-Claris.
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-Claris 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-CLARIS IS USED FOR
Midazolam-Claris may be injected as a sedative during some short
medical procedures.
Midazolam-Claris 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-Claris over
several hours or days as a sedative.
Midazolam belongs to a group of medicines called benzodiazepines. They
are thought to
work by their action on brain chemicals. Midazolam-Claris can cause
sedation, hypnosis,
amnesia and/or anaesthesia, depending on the dose.
Your doctor, however, may have prescribed Midazolam-Claris for another
purpose. ASK
YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MIDAZOLAM-CLARIS HAS
BEEN
PRESCRIBED FOR YOU.
Midazolam-Claris is only given by a doctor trained to use this
medicine. If you will be
receiving Midazolam-Claris 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-CLARIS
_DO NOT USE MIDAZOLAM-CLARIS IF_
•
YOU HAVE HAD AN ALLERGIC REACTION TO MIDAZOLAM, 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 ALCOHOLIC INTOXICATION
IF YOU ARE NOT SURE
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Summary of Product characteristics
MIDAZOLAM-BAXTER (midazolam)
Version 1.1
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AUSTRALIAN PRODUCT INFORMATION – MIDAZOLAM-
BAXTER (MIDAZOLAM) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Midazolam Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Midazolam Hydrochloride (1 mg/mL or 5 mg/mL)
Excipients: Sodium Chloride, Hydrochloric Acid (to produce
hydrochloride) and Sodium
Hydroxide in water for injection adjusted to pH 3.3.
3
PHARMACEUTICAL FORM
Sterile solution for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midazolam is a short-acting sleep inducing agent for sedation for
short procedures, induction
of anaesthesia, and for prolonged sedation in intensive care units.
•
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
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,
MIDAZOLAM-BAXTER (midazolam)
Version 1.1
2 of 23
provision for monitoring, detection and correction of these reactions
must be made for every
patient to whom Midazolam-Baxter injection is administered, regardless
of age or health status.
The dosage of Midazolam- Baxter administered should be ad
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