Transcription of SUMMARY OF PRODUCT CHARACTERISTICS
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SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX ISUMMARY OF PRODUCT CHARACTERISTICS21. NAME OF THE MEDICINAL PRODUCTKEYTRUDA 25 mg/mL concentrate for solution for QUALITATIVE AND QUANTITATIVE COMPOSITIONOne vial of 4 mL of concentrate contains 100 mg of mL of concentrate contains 25 mg of is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody(IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinesehamster ovary cells by recombinant DNA the full list of excipients, see section PHARMACEUTICAL FORMC oncentrate for solution for to slightly opalescent, colourless to slightly yellow solution, pH .4. CLINICAL Therapeutic indicationsMelanomaKEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic)melanoma in as monotherapy is indicated for the adjuvant treatment of adults with Stage IIImelanoma and lymph node involvement who have undergone complete resection (see section ).
replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Otherwise treatment should be discontinued. Hypothyroidism Hypothyroidism may be managed with replacement therapy without treatment interruption. Hepatitis NOTE: for RCC patients treated with pembrolizumab in combination with ...
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