Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p294
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 294/312)
Character Range: 17336762–17345154

to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above
                                                                                                                           11. Past COVID-19 infection 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