Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p162
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 162/191)
Character Range: 11149640–11157493

TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
                                                                                                                                                                                                                               Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
                                                                                                                                                                                                                               Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
                                                                                                                                                                                                                               To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment
                                                                                                                                                                                                                               (1) the patient must demonstrate no 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.
C9547               P9547          CN9547           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Moderate to severe spasticity of the upper limb following an acute event                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9547
                                                                                                                                                                                                                               The condition must be moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more; AND
                                                    Clostridium botulinum type A toxin - haemagglutinin complex                                                                                                                The treatment must only be used as second line therapy when standard management has failed; or
                                                                                                                                                                                                                               The treatment must only be used as an adjunct to physical therapy; AND
                                                    IncobotulinumtoxinA                                                                                                                                                        The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND
                                                                                                                                                                                                                               Patient must not have established severe contracture in the limb to be treated;
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a neurologist.  or
                                                                                                                                                                                                                               Must be treated by an orthopaedic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a rehabilitation specialist.  or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a geriatrician.
                                                                                                                                                                                                                               Standard management includes physiotherapy and/or oral spasticity agents.