Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Revolade mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revolade mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to mg eltrombopag. Revolade 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag. Revolade 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag. Revolade 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag. For the full list of excipients, see section 3. PHARMACEUTICAL FORM Film-coated tablet. Revolade mg film-coated tablets White, round, biconvex film-coated tablet (approximately mm in diameter) debossed with GS MZ1 and on one side.
platelet count is achieved, normally around 50,000-75,000/µl. FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter. Dose reductions on the daily dose by 25 mg should be considered if platelet counts exceed the required target. It is recommended to wait for
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