Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p28
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 28/38)
Character Range: 98423–103662

episode resulting in hospitalisation.
                                                       Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
                                                       For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
                                                       Access to this drug through this restriction is permitted irrespective of vaccination status.
                                                       Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
                                                       Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
                                                       This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
C16194  P16194  CN16194  Testosterone                  Constitutional delay of growth or puberty                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                       Patient must be under 18 years of age.
                                                       Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
                                                       The treatment must be applied to the scrotum, where possible.
                                                       The name of the specialist must be included in the authority application.
C16195  P16195  CN16195  Testosterone                  Constitutional delay of growth or puberty                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                       The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                       Patient must be under 18 years of age.
                                                       Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
                                                       The treatment must be applied to the scrotum, where possible.
                                                       The name of the specialist must be included in the authority application.
C16197  P16197  CN16197  Daunorubicin with cytarabine  Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                       Consolidation therapy
                                                       The treatment must be for consolidation treatment following induction treatment with this product; AND
                                                       The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND
                                                       The treatment must not exceed two cycles of consolidation therapy under this restriction.
                                                       This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital