Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2891
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2891
Character Range: 1328945–1331158

2891                                      LACTO-N-TETRAOSE                                                                              A         Lactose is a mandatory component of lacto-N-tetraose.
                                                                                                                                                  The route of administration for medicines that contain lacto-N-tetraose must be limited to oral.
                                                                                                                                                  The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                                  a) 2 g of lacto-N-tetraose to individuals aged 1 year and older; and
                                                                                                                                                  b) 0.6 g of lacto-N-tetraose to individuals aged more than 6 months to 11 months (inclusive); and
                                                                                                                                                  c) 0.8 g of lacto-N-tetraose to individuals aged up to 6 months (inclusive).
                                                                                                                                                  One of the following statements (or words to the same effect) is required on the medicine label:
                                                                                                                                                  a) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing lacto-N-tetraose'; or
                                                                                                                                                  b) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk or other products containing lacto-N-tetraose'.