Pfizer (Australia) MIDAZOLAM INJECTION midazolam 5mg/5mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

midazolam, Quantity: 1 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections

Administration route:

Intravenous, Intramuscular

Units in package:

10 x 5ml ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intravenously 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 an opioid. Induction of anaesthesia preliminary to administration of other anaesthetic agents. With the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. Intermittent intravenous administration or continuous infusion for: sedation in intensive care units. Intramuscularly 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: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-12-24

Patient Information leaflet

MIDAZOLAM INJECTION
_Midazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Midazolam Injection.
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 taking Midazolam
injection against the benefits it is
expected to have for you.
This medicine is likely to be used
while you are in hospital. If possible,
please read this leaflet carefully
before this medicine is given to you.
In some cases this leaflet may be
given to you after the medicine has
been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MIDAZOLAM
INJECTION IS USED FOR
_WHAT IT DOES_
Midazolam is used as a sedative
during short medical procedures,
before you have an operation or if
you are in intensive care. Midazolam
may also be given to help induce
anaesthesia before you are given
another anaesthetic.
It belongs to a group of medicines
called benzodiazepines.
_HOW IT WORKS_
This medicine works by slowing
down the brain to cause sleepiness
and temporary loss of memory and
anaesthesia to prevent pain and
discomfort during surgery.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
MIDAZOLAM INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU WILL NOT BE GIVEN MIDAZOLAM
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
midazolam or any other
benzodiazepines
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE MIDAZOLAM INJECTION IF
YOU HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CON

Summary of Product characteristics

Version: pfpmidai21118
Supersedes: pfpmidai10218
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION –
MIDAZOLAM INJECTION (MIDAZOLAM)
1.
NAME OF THE MEDICINE
Midazolam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam Injection contains 1 mg/mL or 5 mg/mL midazolam (as
hydrochloride)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Midazolam Injection is a clear, colourless to pale yellow solution for
injection. Midazolam
Injection is adjusted to pH 3.3.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTRAVENOUSLY 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 an
opioid.
•
induction of anaesthesia preliminary to administration of other
anaesthetic agents. With
the use of an opioid premedicant, induction of anaesthesia can be
obtained with a
narrower dose range and in a shorter period of time.
INTERMITTENT INTRAVENOUS ADMINISTRATION OR CONTINUOUS INFUSION FOR:
•
sedation in intensive care units.
INTRAMUSCULARLY 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
THIS PRODUCT IS FOR SINGLE PATIENT USE ONLY. USE ONCE AND DISCARD ANY
RESIDUE.
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
cardiorespiratory adverse events have
been reported, provision for monitoring, detection and correction of
these reactions must be
Version: pfpmidai21118
Supersedes: pfpmidai10218
Page 2 of 23
made for every patient to whom midazolam is administered, regardless
of age or health status.
The dosage of midazolam administered should be adjusted according to
the type and amount
of premedica