Rocuronium

Main information

  • Trade name:
  • Rocuronium Kabi rocuronium bromide 25mg/2.5mL solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Rocuronium Kabi rocuronium bromide 25mg/2.5mL solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216643
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216643

Rocuronium Kabi rocuronium bromide 25mg/2.5mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

12/11/2014

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. Rocuronium Kabi rocuronium bromide 25mg/2.5mL solution for injection vial

Product Type

Single Medicine Product

Effective date

28/04/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS,Rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide

muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age.,Rocuronium is also indicated as an adjunct

to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has

not been studied in infants and children.,Rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

5 x 2.5mL

(S4) Prescription Only Medicine

10 x 2.5mL

(S4) Prescription Only Medicine

Components

1. Rocuronium Kabi rocuronium bromide 25mg/2.5mL solution for injection vial

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

A clear, colourless to pale brownish-yellow solution.

Active Ingredients

Rocuronium bromide

10 g/L

© 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 26.11.2017 at 07:18:29 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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