Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
{{id}} {{{paragraph}}}
Example: barber
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Bavencio 20 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg of avelumab. One vial of 10 mL contains 200 mg of avelumab. Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out. Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: