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Therapeutic Goods (Listing) Notice 2009 (No. 3)

Federal Register of Legislative Instruments (FRLI): Legislative Instrument - F2009L03484 (11 September 2009)

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COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the ARTG) for listed goods:

  • preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) that contain, as their therapeutically active ingredient, potassium chloride for oral rehydration therapy, subject to the following conditions:
    • the formulation complies with the requirements specified in the British Pharmacopoeia monograph for Oral Rehydration Salts;
    • the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the following criteria, as specified by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) in the document, "Expert consultation on oral rehydration salts formulation, 18 July 2001".
COMPONENT CONCENTRATION
Sodium 60 - 90 mEq/l
Glucose At least equal that of sodium and less than 111 mmol/l
Potassium 15 - 25 mEq/l

Total Osmolarity

200 - 310
  •  
    • the product label includes the following advisory statements:
      • "Contains potassium. If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children",
      • "Use only as directed", and
      • "If diarrhoea persists, seek medical advice", and
    • the product label includes a description of the symptoms of dehydration for the benefit of consumers;
    • the proposed directions for use must be clearly outlined on the label; and
    • when indicated for use in children, the directions for use on the product label includes the following additional directions:
Age of child Additional Directions
Under 6 months Medical advice should be sought if diarrhoea persists for more than 6 hours.
Under 3 years Medical advice should be sought if diarrhoea persists for more than 12 hours.
3-6 years Medical advice should be sought if diarrhoea persists for more than 24 hours.
Over 6 years Medical advice should be sought if diarrhoea persists for more than 48 hours.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Pursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods.

Dated this 31st day of August 2009

Rohan Hammett
Delegate of the Minister for Health and Ageing

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