Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4589
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4589
Character Range: 2165509–2168386

4589                                      SODIUM HYALURONATE                                                                       A, E      When for use as an excipient ingredient, sodium hyaluronate must only be used in medicines with a topical route of administration for dermal application.
                                                                                                                                             When for use as an active ingredient:
                                                                                                                                             (a) the molecular mass of sodium hyaluronate must be between 600 and 1600 kilodaltons; and
                                                                                                                                             (b) sodium hyaluronate must only be used in medicines when the route of administration is limited to:
                                                                                                                                             (i) topical for dermal application; or
                                                                                                                                             (ii) oral.
                                                                                                                                             When for use in a topical medicine for dermal application the concentration of sodium hyaluronate in the medicine must not exceed 2.0%.
                                                                                                                                             When for use as an active ingredient and the route of administration is oral:
                                                                                                                                             (a) the maximum recommended daily dose must not provide more than 200 milligrams sodium hyaluronate;
                                                                                                                                             (b) the recommended duration of use of the medicine must be limited to three months; and
                                                                                                                                             (c) the following warning statements (or words to the same effect) are required on the medicine label :
                                                                                                                                             - (ADULT) 'Adults only'; and
                                                                                                                                             - (PREGNT) ' Not recommended for use by pregnant and lactating women'.