MIDAZOLAM ACCORD midazolam (as hydrochloride) 15 mg/3 mL solution for injection ampoules
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
05-10-2021
Summary of Product characteristics
(SPC)
07-05-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
midazolam, Quantity: 15 mg
Available from:
Accord Healthcare Pty Ltd
INN (International Name):
Midazolam
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sodium hydroxide; water for injections; sodium chloride; hydrochloric acid
Administration route:
Intramuscular, Intravenous
Units in package:
Pack 10 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, sterile, isotonic, preservative-free solution in clear glass ampoules (type - 1).; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-05-16
Patient Information leaflet
Midazolam Accord – version 5
1
MIDAZOLAM ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN MIDAZOLAM ACCORD?
Midazolam Accord contains the active ingredient midazolam. Midazolam
Accord can cause sedation, hypnosis, amnesia and/or
anaesthesia, depending on the dose, and may be given to you to produce
sleepiness or drowsiness, or to relieve anxiety.
For more information, see Section 1. Why am I being given Midazolam
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN MIDAZOLAM ACCORD?
Do not use if you have ever had an allergic reaction to an any
medicine containing midazolam, any other benzodiazepine
medicine, or any of the ingredients listed at the end of this leaflet.
You should also not be given it if you have severe muscle weakness
(myasthenia gravis), acute narrow angle glaucoma or if you
are suffering from shock, coma or acute alcoholic intoxication.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Midazolam Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Midazolam Accord and affect how it
works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN MIDAZOLAM ACCORD?
Midazolam Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Midazolam
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN MIDAZOLAM ACCORD?
THINGS YOU
SHOULD DO
•
Tell any other doctors, dentists, and pharmacists who are treating you
that you are being
treated with Midazolam Accord
•
Tell your doctor before you take any other medicines - whether they
require a prescription or
not
•
Do not drink alcohol for at least 12 hours
Read the complete document
Summary of Product characteristics
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
MIDAZOLAM ACCORD INJECTION
1
NAME OF THE MEDICINE
Midazolam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam Accord 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 Accord 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 been reported, provision for
monitoring, detection and correction of these reactions must be made
for every patient to whom
Midazolam Accord injection is administered, regardless of age or
health status. The dosage of midazolam
administered should be adjusted according to the type and amount of
premedication used.
INTRAVENOUSLY (IV)
Midazolam should be administered slowly.
_Conscious Sedation_
_Endoscopic or Cardiovascular Procedures:_
For conscious sedation, midazolam can be used either alo
Read the complete document
