Transcription of DATA SHEET 1. PRODUCT NAME (strength …
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DATA SHEET 1. PRODUCT NAME (strength …
171211 Xarelto DS Page 1 of 35 DATA SHEET 1. PRODUCT NAME (strength pharmaceutical form) Xarelto 10 mg film-coated tablets Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rivaroxaban is an odourless, non-hygroscopic white to yellowish powder. Rivaroxaban is practically insoluble in water and aqueous media in the pH range 1 to 9. An amount of approximately 5 - 7 mg/L rivaroxaban is pH-independently soluble in aqueous media at 25 C. Rivaroxaban is only slightly soluble in organic solvents ( acetone, polyethylene glycol 400). Xarelto 10 mg 1 film-coated tablet contains 10 mg rivaroxaban. Each 10 mg film-coated tablet contains mg lactose monohydrate (= mg lactose) per tablet.
171211 Xarelto DS Page 2 of 35 . 4. CLINICAL PARTICULARS . 4.1 Therapeutic indications . Xarelto is indicated for • Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip
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