Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Rivaroxaban 20mg
Bayer New Zealand Limited
Rivaroxaban 20 mg
20 mg
Film coated tablet
Active: Rivaroxaban 20mg Excipient: Croscarmellose sodium Hypromellose Iron oxide red Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide
Blister pack, PVC/PVDC/Al or PP/Al blister, 7 tablets
Prescription
Prescription
Bayer AG
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al or PP/Al blister - 7 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al or PP/Al blister - 28 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al or PP/Al blister - 84 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al or PP/Al blister - 98 tablets - 3 years from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al or PP/Al blister - 100 tablets - 3 years from date of manufacture stored at or below 30°C
2011-02-28
XARELTO ® CMI V5.0 1 XARELTO ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING XARELTO? XARELTO contains the active ingredient rivaroxaban. XARELTO reduces the tendency of blood to form clots and is used to treat a number of conditions. For more information, see Section 1. Why am I using XARELTO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE XARELTO? Do not use if you have ever had an allergic reaction to XARELTO or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use XARELTO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with XARELTO and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE XARELTO? • Follow all directions given to you by your doctor and other health professionals carefully including: • How many tablets to take each day • If you need to take these tablets with food More instructions can be found in Section 4. How do I use XARELTO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING XARELTO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking XARELTO. • Take XARELTO exactly as your doctor has prescribed. • THINGS YOU SHOULD NOT DO • Do not take XARELTO to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. • Do not stop taking your medicine or lower the dosage without checking with your doctor first. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how XARELTO affects you. • If this medicine makes you fee Perskaitykite visą dokumentą
XARELTO DS VX7.0; CCDS 16, 18 Page 1 of 46 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ® (STRENGTH PHARMACEUTICAL FORM) XARELTO ® rivaroxaban 2.5 mg film-coated tablets XARELTO ® rivaroxaban 10 mg film-coated tablets XARELTO ® rivaroxaban 15 mg film-coated tablets XARELTO ® rivaroxaban 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of XARELTO - 2.5 mg contains 2.5 mg of rivaroxaban. - 10 mg contains 10 mg of rivaroxaban. - 15 mg contains 15 mg of rivaroxaban. - 20 mg contains 20 mg of rivaroxaban. Excipient with known effect - 2.5 mg contains 35.70 mg lactose (as monohydrate) - 10 mg contains 27.90 mg lactose (as monohydrate) - 15 mg contains 25.40 mg lactose (as monohydrate) - 20 mg contains 22.90 mg lactose (as monohydrate) See Information about excipients For the full list of excipient(s) see section 6.1. 3. PHARMACEUTICAL FORM XARELTO 2.5 MG Film-coated, round biconvex light-yellow immediate release tablets (6 mm diameter, 9 mm radius of curvature) and weight of 87.5 mg for oral use. BAYER-cross on one side and "2.5" and a triangle on the other side. XARELTO 10 MG Film-coated, round, biconvex, light red immediate release tablets of 6 mm diameter and 9 mm radius of curvature and weight of 87.5 mg for oral use. Bayer-cross on one side and 10 and a triangle on the other side. XARELTO 15 MG Film-coated, round, biconvex, red tablets of 6 mm diameter, 9 mm radius of curvature and weight of 87.5 mg for oral use. Bayer-cross on one side and a triangle and 15 on the other side. XARELTO 20 MG Film-coated, round, biconvex, brown red tablets of 6 mm diameter, 9 mm radius of curvature and weight of 87.5 mg for oral use. Bayer-cross on one side and a triangle and 20 on the other side. XARELTO DS VX7.0; CCDS 16, 18 Page 2 of 46 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XARELTO is indicated for • Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. • Prevention of stroke and systemic embolism in adult pat Perskaitykite visą dokumentą