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Brand name: Ronapreve TM
Active ingredients: casirivimab, imdevimab
What it is used for
Ronapreve has provisional approval for the indications below:,Treatment:,Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.,Post-exposure prophylaxis:,Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either:, have a medical condition making them unlikely to respond to or be protected by vaccination, OR, are not vaccinated against COVID-19.,(refer to Section 4.2 Dose and method of administration and 5.1, Clinical Trials),Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.,The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,The use of Ronapreve should take into account information on the activity of Ronapreve against viral variants of concern. See sections 4.4 and 5.1.
How to take it
This medicine is a pack that contains more than one part.
Part 1: Injection, solution
6 ml glass vial containing clear to slightly opalescent and colourless to pale yellow solution.
The way to take this medicine is: Intravenous Infusion.
Part 2: Injection, solution
6 ml glass vial containing clear to slightly opalescent and colourless to pale yellow solution.
The way to take this medicine is: Intravenous Infusion.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Storage instructions
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Do not Shake
- Shelf lifetime is 18 Months.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Pregnant or planning a pregnancy?
For the active ingredient casirivimab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
For the active ingredient imdevimab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Consumer Medicines Information (CMI)
For side effects, taking other medicines and more
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Need more information?
These trusted information partners have more on this topic.
Top results
RACGP - What is the COVID-19 treatment sotrovimab?
Reproduced with permission from The Royal Australian College of General Practitioners
Read more on RACGP - The Royal Australian College of General Practitioners website
What you need to know about COVID-19 - Immunisation Coalition
What you need to know about COVID-19 so you can protect yourself, your friends, family and the rest of the community.
Read more on Immunisation Coalition website
Top results
RACGP - What is the COVID-19 treatment sotrovimab?
Reproduced with permission from The Royal Australian College of General Practitioners
Read more on RACGP - The Royal Australian College of General Practitioners website