Tabulated summary of adverse reactions: The safety profile of the product is based on adverse reactions reported in clinical trials and spontaneous reporting.
The adverse reactions in Table 4 are listed as follows by system organ class and frequency. Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); not known (frequency cannot be estimated from the available data). (See Table 4.)
![](https://mpfshstrg.blob.core.windows.net/mpf-uat-common-resources/Images/monograph/table.gif)
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
View ADR Monitoring Form