Bricor Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Tabulated list of adverse drug reactions: Adverse drug reactions from the PLATO and PEGASUS clinical studies with Ticagrelor are listed by MedDRA System Organ Class (SOC) and frequency category. Within each SOC and frequency category, adverse drug reactions are presented in order of decreasing seriousness. Frequency categories are defined according to the following conventions: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). (See Table 2.)

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Analysis of Overall Bleeding Events: see Table 3.

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In PLATO, time to first PLATO-defined 'Total Major' bleeding for Ticagrelor did not suffer significantly from that of clopidogrel. There were few fatal bleeding events in the study, 20 (0.2%) for Ticagrelor 90 mg twice daily.

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Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals