Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p20
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 51808–54878

size of not less than 1.5 millimetres; and

           the following information is displayed in a text size of not less than 1.0 millimetre:

           (d) the quantity of the medicine; and

       (e) the batch number of the medicine preceded by the batch number prefix; and

       (f) the expiry date of the medicine preceded by the expiry date prefix; and

           (g) the approved route of administration for the medicine, such as 'intravenous', 'intramuscular' or 'subcutaneous' or other phrase, word or abbreviation denoting the approved route(s) of administration; and

           (h) if the medicine contains only one active ingredient - the name of the active ingredient and the quantity or proportion of the active ingredient in the medicine, or suitable unambiguous abbreviation of the name and quantity, unless the name of the medicine includes this information; and
            1.             if the medicine is available in more than one strength, the quantity or proportion of each active ingredient, unless the name of the medicine includes this information.

        1.          Injections with a stated volume of fill of 100 millilitres or more

       In addition to the requirements under subsection 10(2) or 10(3), a medicine that is an injection with a stated volume of fill equal to or greater than 100 millilitres must also include the following information on the label on the container and the primary pack:

           (a) where the medicine contains one or more active ingredients that are amino acids and/or protein - a statement giving the total amount of nitrogen, in grams, in the stated volume of fill of the injection in the container; and

           (b) where the medicine is intended for use as an energy source - a statement of the energy equivalent, in kilojoules, of the stated volume of fill of the injection in the container; and

           (c) a statement specifying whether the injection is hypotonic, hypertonic or isotonic; and

           (d) the osmolality of the injection solution; and

           (e) the pH range of the injection solution.

        1.          Haemofiltration and haemodiafiltration solutions

       The label on the container and on the primary pack of a medicine that is a haemofiltration or haemodiafiltration solution must, in addition to the requirements referred to in sections 8 and 9, include:

            1.           the name and quantity of each active ingredient per litre of solution following preparation in accordance with directions; and

            2.          the name and quantity of each active ingredient in terms of millimoles per litre of solution following preparation  in accordance with directions; and

            3.           a statement specifying whether the solution is hypotonic, hypertonic or isotonic; and

            4.          the osmolality of the solution; and

            5.           the pH range of the solution; and

            6.            a statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' or words