Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RIVAROXABAN (MICRONIZED)
BAYER INDONESIA - Indonesia
RIVAROXABAN (MICRONIZED)
15 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
BAYER AG - GERMANY
2018-03-22
ID/Xarelto/Rivaroxaban 10, 15 & 20 mg - Film Coated Tablet/Einstein Choice KOMNAS approval & BPOM deficiency letter (EMA reference) 1 XARELTO ® FILM-COATED TABLET Important information, please read carefully! COMPOSITION XARELTO 10 MG 1 film-coated tablet contains 10 mg rivaroxaban. XARELTO 15 MG 1 film-coated tablet contains 15 mg rivaroxaban. _ _ XARELTO 20 MG 1 film-coated tablet contains 20 mg rivaroxaban. PHARMACEUTICAL FORM Film-coated tablet (tablet). XARELTO 10 MG Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side. XARELTO 15 MG Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side. XARELTO 20 MG WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING XARELTO, INCREASES THE RISK OF THROMBOTIC EVENTS. IF ANTICOAGULATION WITH XARELTO IS DISCONTINUED FOR A REASON OTHER THAN PATHOLOGICAL BLEEDING OR COMPLETION OF A COURSE OF THERAPY, CONSIDER COVERAGE WITH ANOTHER ANTICOAGULANT _[POSOLOGY AND METHOD OF ADMINISTRATION, SPECIAL WARNINGS AND PRECAUTIONS FOR USE, AND CLINICAL EFFICACY AND SAFETY]_. B. SPINAL/EPIDURAL HEMATOMA EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH XARELTO WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE: • USE OF INDWELLING EPIDURAL CATHETERS • CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS • A H Izlasiet visu dokumentu