Hydralyte

Main information

  • Trade name:
  • Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221283
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221283

Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution

ARTG entry for

Medicine Listed

Sponsor

Care Pharmaceuticals Pty Ltd

Postal Address

PO Box 1674,BONDI JUNCTION, NSW, 1355

Australia

ARTG Start Date

14/03/2014

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Hydralyte Ready to use Colour Free Lemonade Flavoured Electrolyte Solution

Product Type

Single Medicine Product

Effective date

3/03/2015

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words

to that effect].

If diarrhoea persists for more than 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

that effect].

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

Specific Indications

Helps replace water and electrolytes lost due to vomiting, diarrhoea, heavy sweating, fever, vigorous exercise and other dehydrating conditions such as

excessive consumption of alcohol or due to a hot or dry environment.

Hydralyte may be taken on the first signs of fluid loss due to dehydrating conditions such as vomiting and diarrhoea.

Hydralyte may also be taken to help manage dehydration.

Dehydration occurs when the body loses more fluid and essential mineral salts (electrolytes) than it needs to function properly. This often happens after

vomiting or bouts of diarrhoea.

Dehydration can also occur after sweating from excessive heat or exercise, fever, or due to a lack of fluid intake during times of ill health or nausea, or

after consuming excessive amounts of alcohol.

Dehydration following vomiting or diarrhoea can be dangerous in babies, young children under 5 years old and in elderly people.

Suitable for paediatric use.

Suitable for use during pregnancy.

Hydralyte Colour Free Solution is a scientifically formulated electrolyte solution containing balanced essential electrolytes.

It contains sodium - an electrolyte essential for water retention and rapid water uptake; and potassium - vital for nerve and muscle function.

It also contains a limited amount of glucose to assist with the absorption of electrolytes and water.

Avoid mixing Hydralyte with soft drink, sports drink, cordial or fruit juice as these can interfere with the rehydration process or worsen the dehydration

such as by worsening diarrhoea and stripping the body of essential mineral salts.

Hydralyte is readily absorbed and fast acting; making it possible to rehydrate quickly.

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:59:53 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

Citric acid monohydrate

4.8 mg/mL

glucose monohydrate

16 mg/mL

Potassium citrate

2.2 mg/mL

sodium chloride

2.5 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 2 of

Produced at 26.11.2017 at 12:59:53 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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