ORION

Main information

  • Trade name:
  • ORION CHLORAL HYDRATE MIXTURE 500mg/10mL bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORION CHLORAL HYDRATE MIXTURE 500mg/10mL bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 42849
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

42849

ORION CHLORAL HYDRATE MIXTURE 500mg/10mL bottle

ARTG entry for

Medicine Registered

Sponsor

Orion Laboratories Pty Ltd T/A Perrigo Australia

Postal Address

25-29 Delawney Street,BALCATTA, WA, 6021

Australia

ARTG Start Date

26/11/1992

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Products

1. ORION CHLORAL HYDRATE MIXTURE 500mg/10mL bottle

Product Type

Single Medicine Product

Effective date

27/03/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS AS AT 19 SEPTEMBER 2003: Chloral Hydrate Mixture is indicated pre-operatively to produce sedation. It is also indicated for short term

(not more than 2 weeks) use as a hypnotic to assist in sleep disorders.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

500mL

(S4) Prescription Only Medicine

Components

1. oral liquid

Dosage Form

Oral Liquid, solution

Route of Administration

Oral

Visual Identification

Turbid, pale pink, syrupy liquid

Active Ingredients

Chloral hydrate

50 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 01.12.2017 at 11:03:21 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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