Transcription of PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
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Casirivimab and imdevimab for injection Page 1 of 26 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCasirivimab and imdevimab for injection solutions for infusion, each available as 1332 mL and 300 mL (120mg/mL) single-use vials Anti-SARS-CoV-2 spike protein monoclonal antibodies HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 DRUG BASED ON LIMITED CLINICAL TESTING IN HUMANS AND/OR QUALITY INFORMATION Casirivimab and imdevimab are indicated for: Casirivimab and imdevimab, to be administered together, are indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high-risk for progressing to hospitalization and/or death. The use of casirivimab and imdevimab are permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO)*, pending the results of trials to verify its clinical benefit.
10. This product is preservative-free and therefore, the diluted infusion solution should be administered immediately. o If immediate administration is not possible, store the diluted combined casirivimab and imdevimab infusion solution in the refrigerator between 2°C to 8°C (36°F to 46°F) for
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