Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2890
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2890
Character Range: 1326952–1328945

2890                                      LACTO-N-NEOTETRAOSE                                                                           A         Lactose is a mandatory component of lacto-N-neotetraose.
                                                                                                                                                  The route of administration for medicines that contain lacto-N-neotetraose must be limited to oral.
                                                                                                                                                  The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                                  (a) 1.5 g of lacto-N-neotetraose to individuals aged 4 years and older; and
                                                                                                                                                  (b) 0.6 g of lacto-N-neotetraose to individuals aged up to 3 years (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-neotetraose'; 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-neotetraose'.