Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p44
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 44/191)
Character Range: 9968249–9982984

deterioration in FEV1 compared to baseline; AND
                                                                                                                                                                                                                               (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
                                                                                                                                                                                                                               Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
C5742               P5742          CN5742           Ziprasidone                                                                                                                                                                Acute mania or mixed episodes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5742
                                                                                                                                                                                                                               The condition must be associated with bipolar I disorder; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               The treatment must be limited to up to 6 months per episode.
C5743               P5743          CN5743           Ondansetron                                                                                                                                                                Nausea and vomiting
                                                                                                                                                                                                                               The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
C5744               P5744          CN5744           Norfloxacin                                                                                                                                                                Acute bacterial enterocolitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures

C5746               P5746          CN5746           Ticagrelor                                                                                                                                                                 Acute coronary syndrome (myocardial infarction or unstable angina)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 5746
                                                                                                                                                                                                                               The treatment must be in combination with aspirin.
C5769               P5769          CN5769           Vancomycin                                                                                                                                                                 Infection
                                                                                                                                                                                                                               The treatment must be initiated in a hospital; AND
                                                                                                                                                                                                                               The condition must be one in which vancomycin is an appropriate antibiotic.
C5771               P5771          CN5771           Nitrazepam                                                                                                                                                                 Myoclonic epilepsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures

C5772               P5772          CN5772           Azithromycin                                                                                                                                                               Cervicitis
                                                                                                                                                                                                                               The condition must be uncomplicated and due to Chlamydia trachomatis.
C5773               P5773          CN5773           Asenapine                                                                                                                                                                  Acute mania or mixed episodes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5773
                                                                                                                                                                                                                               The condition must be associated with bipolar I disorder; AND
                                                                                                                                                                                                                               The treatment must be limited to up to 6 months per episode.
C5775               P5775          CN5775           Bisacodyl                                                                                                                                                                  Constipation
                                                                                                                                                                                                                               Patient must be receiving palliative care.
                                                    Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

C5776               P5776          CN5776           Bisacodyl                                                                                                                                                                  Terminal malignant neoplasia

                                                    Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

C5778               P5778          CN5778           Ondansetron                                                                                                                                                                Nausea and vomiting
                                                                                                                                                                                                                               The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
C5780               P5780          CN5780           Ciprofloxacin                                                                                                                                                              Perichondritis of the pinna                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                                                                                                               The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials.  or
                                                                                                                                                                                                                               The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.
C5781               P5781          CN5781           Fondaparinux                                                                                                                                                               Prevention of venous thromboembolism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 5781
                                                                                                                                                                                                                               Patient must be undergoing major hip surgery.
C5783               P5783          CN5783           Tenecteplase                                                                                                                                                               Acute myocardial infarction
                                                                                                                                                                                                                               The treatment must be administrated within 12 hours of onset of attack.
C5789               P5789          CN5789           Acitretin                                                                                                                                                                  Severe intractable psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with