Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p123
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 123/476)
Character Range: 1615244–1622545

score greater than 45 at 72 hours.
                                                                                                                                            At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
                                                                                                                                            Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records.
                                                                                                                                            Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.
                                                                       C7777                                                                Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Balance of supply
                                                                                                                                            Must be treated by a gastroenterologist (code 87); OR
                                                                                                                                            Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
                                                                                                                                            Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).
                                                                       C8296                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment, Whole body or Continuing treatment, Face, hand, foot ‑ balance of supply
                                                                                                                                            Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of