Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_54
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 54
Character Range: 37921–40288

54                                        2'-FUCOSYLLACTOSE                                                                 A         The route of administration for medicines that contain 2'-fucosyllactose must be limited to oral.

                                                                                                                                      Lactose is a mandatory component of 2'-fucosyllactose.

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

                                                                                                                                      a) 12 g of 2'-fucosyllactose to individuals aged 13 years and older;

                                                                                                                                      b) 4 g of 2'-fucosyllactose to individuals aged between 1 and 12 years (inclusive); and

                                                                                                                                      c) 1.2 g of 2'-fucosyllactose to individuals aged between 1 and 11 months (inclusive).

                                                                                                                                      2'-fucosyllactose is not permitted for use in children under the age of 1 month.

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

                                                                                                                                      a) When the medicine is only for use in individuals aged above 2 years: 'Not to be taken on the same day with other products containing 2'-fucosyllactose' (or words to that effect); or

                                                                                                                                      b) When the medicine is for use in individuals up to and including 2 years of age: 'Not to be taken on the same day with breastmilk or other products containing 2'-fucosyllactose' (or words to that effect).