Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p21
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 54573–57565

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 to that effect.

        1.          Peritoneal dialysis solutions

       The label on the container and on the primary pack of a medicine that is a solution for use in peritoneal dialysis must, in addition to the requirements referred to in sections 8 and 9, include:

           (a) the formulation of the solution expressed in grams per litre and in millimoles per litre, including, if it is a concentrate for a peritoneal dialysis solution, the formulation both before and after dilution; and

           (b) the calculated osmolarity expressed in milliosmoles per litre; and

           (c) the nominal volume of the solution in the container; and

           (d) a statement that the solution is free from bacterial endotoxins, or where applicable, that it is apyrogenic; and

           (e) a statement that the solution is not to be used for intravenous infusion; and

           (f) a statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' or words to that effect; and

           (g) if a concentrate, the statement 'Dilute before use.'

       (8A) Neuromuscular blocking agent-containing medicines

       In addition to the requirements of sections 8 and 9, and the requirements in subsections 10(3), (4), (5) and (15) as applicable, if a medicine contains a neuromuscular blocking agent, then:

           (a) the label on the primary pack must include the warning statement 'Warning: Paralysing agent' in black text on a fluorescent red or warm red background; and

           (b) the label on the container must include the warning statement 'Warning: Paralysing agent' in black text on a fluorescent red or warm red background, except:

              (i) where subsection 10(5) applies, in which case this warning statement may be shortened to 'Warning: Paralyser' or 'Paralyser'; or

              (ii) where subsection 10(15) applies, in which case this warning statement must be on the label of each ampoule, and may be shortened to 'Warning: Paralyser' or 'Paralyser', and may be in any colour text with no background colour.

        1.          Preparations for use on skin and/or mucous membranes or by inhalation, and metered nasal sprays

       The label on a container and on a primary pack (if any) of a medicine that is a preparation for use on skin and/or mucous membranes or is for inhalation or is a metered nasal spray, must, in addition to the requirements referred to in sections 8 and 9 above, include the name of any antimicrobial preservative in the medicine.

        1.      Starter packs

       Where a medicine is presented in a starter pack, in addition to the requirements referred to in sections 8 and