Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p18
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 46540–49390

with a capacity of 100 millilitres or less

       Except where subsection 10(4) or 10(5) below applies in relation to the label on a container, if a medicine is an injection in a container with capacity of 100 millilitres or less, then in addition to the requirements of sections 8 and 9 above, the label on the container and on the primary pack must include:

           (a) the name and quantity of each excipient in the medicine, expressed:

              (i) for single dose injections (including concentrated solutions for injection) - as the nominal mass of that excipient (not including any overage) in the stated volume of fill of the injection in the container;

              (ii) for a powder for injection - as the nominal mass of that excipient (not including any overage) in the container;

              (iii) where the injection is intended for multidose use - as the quantity of that excipient in one millilitre of the injection or where the dose volume is less than one millilitre as the quantity in that dose volume; and

           (b) where the medicine is supplied in a container with potential for multidose use, such as a vial or pre-filled syringe, and an antimicrobial preservative is not included in the medicine - the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' or words to that effect; and

           (c) where the medicine is a concentrated solution for injection, a direction not to administer the solution undiluted; and

           (d) where the medicine is an injection containing iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and

           (e) where the medicine is intended for electrolyte replacement and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:

              (i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and

              (ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).

        1.          Injections in a container with a capacity of 25 millilitres or less

       Except where subsection 10(5) applies, if a medicine is an injection that:

       (a)is in a container with capacity of 25 millilitres or less; and

           (b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(3)

       then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3), it shall be sufficient if the following information is displayed in a text