Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Rivaroxaban 10mg;
Sandoz New Zealand Limited
10 mg
Film coated tablet
Active: Rivaroxaban 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 04F530012 Sodium laurilsulfate
Prescription
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium - 15 dose units - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/aluminium - 30 dose units - 24 months from date of manufacture stored at or below 25°C
2020-01-30
RIVAROXABAN SANDOZ ® 1 RIVAROXABAN SANDOZ ® _rivaroxaban _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rivaroxaban Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rivaroxaban Sandoz against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RIVAROXABAN SANDOZ IS USED FOR The active substance is rivaroxaban. It belongs to a group of medicines called _anticoagulants_ . It works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots. Rivaroxaban Sandoz has been prescribed to you for one of the following uses: • Prevention of blood clots in your veins after a hip or knee replacement operation because after an operation you are at an increased risk of getting blood clots. • Prevention of blood clots in your brain (stroke) and/or other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation • Treatment of blood clots in the veins of your legs (deep vein thrombosis, DVT) and clots in your lung (pulmonary embolism, PE) and to prevent blood clots from re-occurring in your legs and/or lungs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Rivaroxaban Sandoz for another reason. Rivaroxaban Sandoz is a prescription medicine. It should only be used in adults under medical supervision. BEFORE YOU TAKE RIVAROXABAN SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE RIVAROXABAN SANDOZ IF YOU HAVE AN ALLERGY TO: • any medicine containing rivaroxaban • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: Read the complete document
200831-rivaroxaban-sandoz-ds Page 1 of 39 NEW ZEALAND DATA SHEET 1. RIVAROXABAN SANDOZ ® Rivaroxaban Sandoz ® 10 mg film-coated tablets Rivaroxaban Sandoz ® 15 mg film-coated tablets Rivaroxaban Sandoz ® 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Rivaroxaban Sandoz 10 mg film-coated tablet contains 10 mg rivaroxaban. Each Rivaroxaban Sandoz 15 mg film-coated tablet contains 15 mg rivaroxaban. Each Rivaroxaban Sandoz 20 mg film-coated tablet contains 20 mg rivaroxaban Excipient with known effect: _Lactose monohydrate._ For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Rivaroxaban Sandoz 10 mg tablets are approximately 6 mm, peach colored, round, biconvex film- coated tablets marked with "10" on one side. Rivaroxaban Sandoz 15 mg tablets are approximately 6 mm, light orange colored, round, biconvex film-coated tablets marked with "15" on one side. Rivaroxaban Sandoz 20 mg tablets are approximately 7 mm, orange colored, round, biconvex film- coated tablets marked with "20" on one side. 4. CLINICAL PARTICULARS T HERAPEUTIC INDICATIONS Rivaroxaban Sandoz 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 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. • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and pulmonary embolism (see section 4.4 Special warnings and precautions for use for haemodynamically unstable PE patients). D OSE AND METHOD OF ADMINISTRATION DOSE _VTE PREVENTION IN TOTAL HIP AND KNEE REPLACEMENT _ The recommended dose of Rivaroxaban Sandoz for VTE prevention in major orthopaedic surgery of the lower limbs (elective total hip or knee replacement) is a 10 mg tablet taken on Read the complete document