Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
There are no robust data on the frequency of undesirable effects from clinical trials. The following undesirable effects have been reported: See Table 2.
Click on icon to see table/diagram/imageFor safety with respect to transmissible agents, see Precautions.
Paediatric population: Frequency, type and severity of adverse reactions in children are not expected to be different from those of adult population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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