a. For treatment of COVID-19 in adults and adolescents (aged 12 years and weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.
b. For treatment of:
adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen
adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19
Clinical guidelines may recommend the 'off-label' use of some medicines already included in the Australian Register of Therapeutic Goods (ARTG), such as dexamethasone, for the treatment of COVID-19. Off-label prescribing refers to the use of a registered medicine outside of the indications, dose, route of administration or patient group included in the TGA-approved Product Information (PI). Off-label use is not illegal, but is subject to the prescriber's clinical judgement in the setting of informed consent.
Labels for COVID-19 treatments
To enable timely distribution of COVID-19 treatments, international labels will be used during the initial supply in Australia.
Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.