MIDAZOLAM SANDOZ midazolam 50mg/10mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

midazolam

Available from:

Sandoz Pty Ltd

Authorization status:

Registered

Patient Information leaflet

MIDAZOLAM SANDOZ
®
1
MIDAZOLAM SANDOZ
®
_midazolam injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Midazolam Sandoz.
It does not contain all the available
information.
It does not take the place of talking to
your anaesthetist, surgeon, doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Midazolam
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR ANAESTHETIST,
SURGEON, DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET AFTER YOUR
OPERATION OR HOSPITAL STAY.
You may need to read it again.
WHAT MIDAZOLAM
SANDOZ IS USED FOR
Midazolam Sandoz belongs to a
group of medicines called
benzodiazepines. They are thought to
work by their action on brain
chemicals.
Midazolam Sandoz may be injected
as a sedative during some short
medical procedures.
Midazolam Sandoz may be given to
you by injection before an operation
to produce sleepiness or drowsiness.
If you are in an intensive care unit,
you may receive an infusion of
Midazolam Sandoz over several
hours or days as a sedative.
However, your anaesthetist or
surgeon may have prescribed
Midazolam Sandoz for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MIDAZOLAM
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
MIDAZOLAM SANDOZ
_WHEN YOU MUST NOT USE IT _
DO NOT USE MIDAZOLAM SANDOZ IF
1.
YOU HAVE AN ALLERGY TO:

midazolam, or any of the other
ingredients listed at the end of
this leaflet

any other medicine from the
benzodiazepine group of
medicines.
Symptoms of an allergic reaction
may include asthma, wheezing or
shortness of breath, swelling of the
face, lips or tongue which may cause
difficulty in swallowing or breathing,
hives, itching or skin rash or fainting.
2.
YOU HAVE SEVERE MUSCLE
WEAKNESS, ALSO KNOWN AS
MYASTHENIA GRAVIS.
3.
YOU HAVE ACUTE NARROW ANGLE
GLAUCOMA (HIGH PRESSURE IN THE
EYE).
MID

Summary of Product characteristics

Product Information
Midazolam Injection Ampoules
05/2016
Version 08
Page 1
PRODUCT INFORMATION
MIDAZOLAM SANDOZ
® INJECTION AMPOULE
NAME OF THE MEDICINE
_ACTIVE_
Midazolam (as hydrochloride)
_CHEMICAL NAME: _
8-chloro-6-(2-fluorophenyl)-1-methyl- 4_H_-imidazo[1,5-_a_][1,4]
benzodiazepine
_ _
_CHEMICAL STRUCTURE OF MIDAZOLAM _
_MOLECULAR FORMULA_:
C
18
H
13
ClFN
3
_MOLECULAR WEIGHT_:
325.8
_CAS_:
59467-70-8
DESCRIPTION
_ _
Midazolam is a benzodiazepine from the imidazobenzodiazepine group.
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. The
solution is adjusted to a pH of
3.3.
_INACTIVE_
Sodium chloride, hydrochloric acid (to produce hydrochloride), sodium
hydroxide
and water for injections
PHARMACOLOGY
Midazolam is a short acting central nervous system (CNS) depressant
which induces sedation,
hypnosis,
amnesia
and
anaesthesia.
Pharmacokinetic
and
pharmacodynamic
data
in
chronic
intravenous usage are not available beyond 15 days. _ _
The
mechanism
of
action
of
the
benzodiazepines
is
under
continuous
investigation.
Benzodiazepines appear to intensify the physiological inhibitory
mechanisms mediated by gamma-
aminobutyric acid (GABA), the most common inhibitory neurotransmitter
in the brain.
The effects of midazolam on the CNS are dependent on the dose
administered, the route of
administration and the presence or absence of other premedications.
Onset time of sedative effects
Product Information
Midazolam Injection Ampoules
05/2016
Version 08
Page 2
after intramuscular administration is 15 minutes, with peak sedation
occurring 30 to 60 minutes
following injection.
When used intravenously as a sedative for endoscopic or other short
therapeutic or diagnostic
procedures, the end point of slurred speech can be attained within 2.8
to 4.8 minutes, depending on
the total dose administ