B. BRAUN MIDAZOLAM midazolam (as hydrochloride) 50 mg/50 mL Injection, Intravenous Infusion bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

midazolam hydrochloride, Quantity: 1.112 mg/mL (Equivalent: midazolam, Qty 1 mg/mL)

Available from:

B Braun Australia Pty Ltd

INN (International Name):

midazolam hydrochloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous

Units in package:

10 x 50 mL

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 solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2015-06-12

Patient Information leaflet

B. BRAUN MIDAZOLAM – CMI – Version 2.1
1
B BRAUN MIDAZOLAM
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 GIVEN B BRAUN MIDAZOLAM?
B BRAUN MIDAZOLAM contains the active ingredient midazolam
hydrochloride. B BRAUN MIDAZOLAM is used as a sedative
during some short medical procedures.
For more information, see Section 1. Why am I given B BRAUN MIDAZOLAM?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN B BRAUN MIDAZOLAM?
Do not use if you have ever had an allergic reaction to B BRAUN
MIDAZOLAM or any of the ingredients listed at the end of the
CMI.
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 am
given B BRAUN MIDAZOLAM?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with B BRAUN MIDAZOLAM and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW AM I GIVEN B BRAUN MIDAZOLAM?
•
B. BRAUN MIDAZOLAM may be given to you as an injection into a vein or
muscle. It may also be given through an infusion set
in an intensive care unit. Other medications may also be given at the
same time.
•
Your doctor will adjust the dose necessary for you. This depends on
which medical procedure you will be having, your age,
weight and your general health. Elderly patients may need to receive
less.
More instructions can be found in Section 4. How do I receive B BRAUN
MIDAZOLAM? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE GIVEN B BRAUN MIDAZOLAM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving B Braun Midazolam.
•
Tell your doctor if you feel B. BRAUN MIDAZOLAM is not helping you.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines whether they require

Summary of Product characteristics

B Braun Midazolam PI – Version 2.0
Page 1 of 18
NAME OF THE MEDICINE
A
USTRALIAN PRODUCT INFORMATION – B. BRAUN MIDAZOLAM (MIDAZOLAM)
1.
NAME OF THE MEDICINE
MIDAZOLAM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
B. Braun Midazolam 1 mg/mL
1 ML OF SOLUTION CONTAINS 1 MG OF MIDAZOLAM AS 1.112 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH AMPOULE WITH 5 ML SOLUTION
CONTAINS
5 MG OF MIDAZOLAM AS 5.560 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH BOTTLE WITH 50 ML SOLUTION
CONTAINS
50 MG OF MIDAZOLAM AS 55.60 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH BOTTLE WITH 100 ML SOLUTION
CONTAINS
100 MG OF MIDAZOLAM AS 111.2 MG OF MIDAZOLAM
HYDROCHLORIDE
For the full list of excipients, see section 6.1 List of excipients.
B. Braun Midazolam 5 mg/mL
1 ML OF SOLUTION CONTAINS 5 MG OF MIDAZOLAM AS 5.56 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH AMPOULE WITH 1 ML SOLUTION
CONTAINS
5 MG OF MIDAZOLAM AS 5.56 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH AMPOULE WITH 3 ML SOLUTION
CONTAINS
15 MG OF MIDAZOLAM AS 16.68 MG OF MIDAZOLAM
HYDROCHLORIDE
EACH AMPOULE WITH 10 ML SOLUTION
CONTAINS
50 MG OF MIDAZOLAM AS 55.60 MG OF MIDAZOLAM
HYDROCHLORIDE
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1 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.
B Braun Midazolam PI – Version 2.0
Page 2 of 18
•
IM for preoperative sedation (induction of sleepiness or drowsiness
and relief of apprehension)