MIDAZOLAM VIATRIS 5mg/1mL midazolam solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

midazolam, Quantity: 5 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Midazolam

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous Infusion, Intravenous, Intramuscular

Units in package:

10 ampoules, 5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intravenously (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 an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. With the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,Intermittent IV administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,Intramuscularly (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 solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2011-04-01

Patient Information leaflet

MIDAZOLAM VIATRIS
_Midazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MIDAZOLAM
VIATRIS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking MIDAZOLAM
VIATRIS against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT MIDAZOLAM
VIATRIS IS USED FOR
MIDAZOLAM VIATRIS may be
injected as a sedative during some
short medical procedures.
MIDAZOLAM VIATRIS 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 VIATRIS over
several hours or days as a sedative.
MIDAZOLAM VIATRIS belongs to
a group of medicines known as
benzodiazepines.
They are thought to work by their
action on brain chemicals.
MIDAZOLAM VIATRIS can cause
sedation, hypnosis, amnesia and/or
anaesthesia, depending on the dose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
MIDAZOLAM VIATRIS HAS BEEN
PRESCRIBED FOR YOU.
YOUR DOCTOR, HOWEVER, MAY HAVE
PRESCRIBED MIDAZOLAM
VIATRIS FOR ANOTHER PURPOSE.
MIDAZOLAM VIATRIS is only
given by a doctor trained to use this
medicine. If you will be receiving
MIDAZOLAM VIATRIS 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 ARE GIVEN
MIDAZOLAM VIATRIS
_WHEN YOU MUST NOT RECEIVE_
_IT_
DO NOT USE MIDAZOLAM
VIATRIS IF YOU HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
MIDAZOLAM
•
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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
MIDAZOLAM VIATRIS
_midazolam _
1
NAME OF THE MEDICINE
Midazolam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIDAZOLAM VIATRIS midazolam solution for injection is available as a 5
mg/ 5 mL, 5 mg/ 1 mL,
15 mg/ 3 mL and 50 mg/ 10 mL solution.
MIDAZOLAM VIATRIS 5 mg/5 mL
Each mL contains 1 mg of midazolam.
One 5 mL ampoule contains 5 mg of midazolam.
MIDAZOLAM VIATRIS 5 mg/1 mL
Each mL contains 5 mg of midazolam.
One 1 mL ampoule contains 5 mg of midazolam.
One 3 mL ampoule contains 15 mg of midazolam.
One 10 mL ampoule contains 50 mg of midazolam.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTRAVENOUSLY (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 an opioid
•
induction of anaesthesia preliminary to administration of other
anaesthetic agents. With the use of an
opioid premedicant, induction of anaesthesia can be attained with a
narrower dose range and in a shorter
period of time.
INTERMITTENT IV ADMINISTRATION OR CONTINUOUS INFUSION FOR:
•
sedation in intensive care units, intermittent administration or
continuous infusion
INTRAMUSCULARLY (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
DOSE
Dosage should be individualised and drug should be administered
slowly.
MIDAZOLAM VIATRIS – PRODUCT INFORMATION
2
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 made
for every