APO-KETAMINE

Main information

  • Trade name:
  • APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219039
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219039

APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

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. APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

12/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ketamine is recommended:,1. As the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.

Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures;,2. For the induction of anaesthesia prior to

the administration of other general anaesthetic agents;,3. To supplement low-potency agents, such as nitrous oxide.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S8) Controlled Drug

Components

1. APO-KETAMINE ketamine (as hydrochloride) 200 mg/2 mL solution for injection in ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear colourless to slightly yellow solution.

Active Ingredients

Ketamine hydrochloride

115.34 mg/mL

© 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 04:03:57 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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