MIDALIM

Main information

  • Trade name:
  • MIDALIM Midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MIDALIM Midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207234
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207234

MIDALIM Midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

16/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MIDALIM Midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

Product Type

Single Medicine Product

Effective date

19/02/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

48 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 ampoule, 5 Ampoules and 10 Ampoules

(S4) Prescription Only Medicine

Components

1. MIDALIM Midazolam (as hydrochloride) 50 mg/10 mL solution for injection ampoules

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colourless to pale yellow, sterile, isotonic, preservative-free solution

in clear glass ampoules (type - 1).

Active Ingredients

Midazolam

50 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:41:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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