Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p28
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 73298–76221

suitable dose of the liquid after preparation in accordance with the instructions set out on the label of the medicine; or

                  (B) in the case where the medicine is one of a series of strengths containing the same active ingredient - as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid after preparation in accordance with the instructions set out on the label of the medicine with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume; and

                       Example: Where the dose volume is 5 mL after preparation, and there are strengths of 1 mg/mL and 5 mg/mL, these must be labelled as     5 mg in 5 mL and 25 mg in 5 mL, respectively.

              (ii) for any other medicines - as the weight or volume of active ingredient in a stated weight or volume of the medicine, after preparation in accordance with the instructions included in the label of the medicine;

           (e) for a transdermal patch, intrauterine drug delivery system or implant - as the total quantity of the active ingredient in each patch, drug delivery system or implant and the quantity of the active ingredient released in a stated time;

           (f) for a medicine for injection:

              (i) where the medicine is a powder for injection or a concentrated solution for injection, and is not intended for electrolyte replacement – as the stated weight of the active ingredient in the container;

              (ii) where the stated volume of the medicine for injection is greater than 100 millilitres and the medicine is intended:

                   1.        for electrolyte replacement or nutritional therapy; or

                   2.        as a plasma volume expander; or

                   3.        as an additive to any of these types of injection,

              then:

                  (D) as the number of millimoles in the stated volume of the injection in the container for each active ingredient or ion of precisely known molecular weight; or

                  (E) as the weight contained in the stated volume of the injection in the container for each active ingredient for which the molecular weight is not precisely known;

              (iii) where the stated volume of the medicine for injection is greater than 100 millilitres and the medicine contains an active ingredient which is not intended for electrolyte replacement or nutritional therapy or as a plasma volume expander - as the weight of the active ingredient in the stated volume of injection in the container;

              (iv) where the medicine for injection is intended for multidose use:

                  (A) where the stated volume in the container is greater than 1 millilitre - as the quantity of the active ingredient in one millilitre of the injection; and

                  (B) the