Ionolyte

Main information

  • Trade name:
  • Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211732
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211732

Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for

intravenous infusion 500 mL Freeflex bag

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

9/05/2014

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. Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for

intravenous infusion 500 mL Freeflex bag

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ionolyte is indicated for:,-mild metabolic acidosis,-as a source of water and electrolytes

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Plastic

36 Months

Store below 30

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

500mL x 20 bags

Not scheduled. Not considered by committee

Components

1. Ionolyte sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride, Injection for intravenous infusion 500 mL

Freeflex bag

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

Ionolyte solution for infusion is a clear and colourless solution.

Active Ingredients

magnesium chloride hexahydrate

.3 g/L

potassium chloride

.3 g/L

Sodium acetate trihydrate

4.63 g/L

sodium chloride

6.02 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 27.11.2017 at 01:02:16 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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