Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
TABLET
EACH TABLET CONTAINS RIVAROXABAN 10,0 mg
Registered
2012-03-01
Approved XARELTO 10 PIL Bayer (Pty) Ltd Approval Date: 12 May 2022 CCPI15/27.08.2020/SA02/09.2020 Page 1 of 8 PATIENT INFORMATION LEAFLET WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HAEMATOMA A. PREMATURE DISCONTINUATION OF XARELTO INCREASE 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. _ _ B. SPINAL/EPIDURAL HAEMATOMA: EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH XARELTO WHO ARE RECEIVING NEURAXIAL ANAESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HAEMATOMAS 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 HAEMATOMAS IN THESE PATIENTS INCLUDE: • USE OF INDWELLING EPIDURAL CATHETERS • CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HAEMOSTASIS, SUCH AS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS • HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES • HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY • OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF XARELTO AND NEURAXIAL PROCEDURES IS NOT KNOWN MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL IMPAIRMENT. IF NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY. CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN PATIENTS ANTICOAGULATED OR TO BE ANTICOAGULATED FOR THROMBOPROPHYLAXIS. SCHEDULING STATUS: S4 XARELTO 10 Film-coated tablets RIVAROXABAN CONTAINS SUGAR (LACTOSE) READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist, nurse Perskaitykite visą dokumentą
XARELTO 10 Product Information Applicant: Bayer (Pty) Ltd Approved date: 12 May 2022 CCDS16/0.12.2020/SA04/05.2021 Page 1 of 30 SCHEDULING STATUS: S4 WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HAEMATOMA A. PREMATURE DISCONTINUATION OF XARELTO INCREASE 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 [_SEE POSOLOGY AND METHOD OF ADMINISTRATION (4.2), SPECIAL WARNINGS AND PRECAUTIONS _ _(4.4.), AND CLINICAL STUDIES (5.1 & 5.2)_]. _ _ B. SPINAL/EPIDURAL HAEMATOMA: EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH XARELTO WHO ARE RECEIVING NEURAXIAL ANAESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HAEMATOMAS 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 HAEMATOMAS IN THESE PATIENTS INCLUDE: • USE OF INDWELLING EPIDURAL CATHETERS • CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HAEMOSTASIS, SUCH AS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS • HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES • HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY • OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF XARELTO AND NEURAXIAL PROCEDURES IS NOT KNOWN _[SEE WARNINGS AND PRECAUTIONS (4.4) AND UNDESIRABLE EFFECTS (4.8)]. _ MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL IMPAIRMENT. IF NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY _[SEE SPECIAL WARNINGS AND PRECAUTIONS (4.4)]_. CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN PATIENTS ANTICOAGULATED OR TO BE ANTICOAGULATED FOR THROMBOPROPHYLAXIS _(SEE SPECIAL WARNINGS AND PRECAUTIONS (4.4)_ Perskaitykite visą dokumentą