Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_217
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 217
Character Range: 124998–126904

217                                       3-FUCOSYLLACTOSE                                                                  A         Lactose is a mandatory component of 3-fucosyllactose.

                                                                                                                                      The route of administration for medicines that contain 3-fucosyllactose must be limited to oral.

                                                                                                                                      The maximum recommended daily dose of the medicine must not provide more than:

                                                                                                                                      (a) 2 g of 3-fucosyllactose to individuals aged 0 to 3 years (inclusive); and

                                                                                                                                      (b) 5 g of 3-fucosyllactose to individuals aged 4 years and older.

                                                                                                                                      One of the following statements is required on the medicine label:

                                                                                                                                      (i) 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 3-fucosyllactose' (or words to that effect); or

                                                                                                                                      (ii) 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 3-fucosyllactose' (or words to that effect).