Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
apixaban, Quantity: 2.5 mg
Bristol-Myers Squibb Australia Pty Ltd
Apixaban
Tablet, film coated
Excipient Ingredients: lactose; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow
Oral
10 tablets, 60 tablets, 30 tablets, 14 tablets, 20 tablets, 100 tablets
(S4) Prescription Only Medicine
ELIQUIS is indicated for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery.,ELIQUIS is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients.,ELIQUIS is indicated for the prevention of recurrent DVT and PE in adult patients.
Visual Identification: Yellow, round, biconvex film-coated tablet with "893" debossed on one side and "2 1/2" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2011-07-21
ELIQUIS ® (ELLE-E-KUIS) _apixaban_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Eliquis. 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 Eliquis against the benefits it is expected to 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 ELIQUIS IS USED FOR _WHAT ELIQUIS DOES_ This medicine is used to: • prevent blood clots in your veins after a hip or knee replacement surgery. After an operation you are at an increased risk of getting blood clots. • treat blood clots occurring in deep veins (Deep Vein Thrombosis [DVT]) and clots in your lungs (Pulmonary Embolism [PE]) and also to prevent these from recurring. • prevent stroke and blood clots in a condition called atrial fibrillation, which is a type of abnormal heart rhythm. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of having a stroke. _HOW ELIQUIS WORKS_ The active substance in Eliquis is apixaban. It belongs to a group of medicines called antithrombotic agents. It works by inhibiting a blood clot forming substance called Factor Xa. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine in children and adolescents under the age of 18 years. BEFORE YOU TAKE ELIQUIS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ELIQUIS IF YOU HAVE AN ALLERGY TO: • any medicine containing apixaban Citiți documentul complet
Version: bqpeliqu10620 Supersedes: bqpeliqu10520 Page 1 of 58 AUSTRALIAN PI – ELIQUIS ® (APIXABAN) 1 NAME OF THE MEDICINE Apixaban 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg film-coated tablet contains 2.5 mg apixaban. Each 5 mg film-coated tablet contains 5 mg apixaban. List of excipients with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. ELIQUIS containing 2.5 mg apixaban for oral administration is available as yellow round, biconvex, film-coated tablets debossed with “893” on one side and “2½” on the other side. ELIQUIS containing 5 mg apixaban for oral administration is available as pink oval-shaped, biconvex, film-coated tablets debossed with “894” on one side and “5” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELIQUIS is indicated for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery. ELIQUIS is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients. ELIQUIS is indicated for the prevention of recurrent DVT and PE in adult patients. 4.2 DOSE AND METHOD OF ADMINISTRATION ELIQUIS can be taken with or without food. MISSED DOSE If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice daily administration should be resumed. The dose should not be doubled to make up for the missed dose. Version: bqpeliqu10620 Supersedes: bqpeliqu10520 Page 2 of 58 PREVENTION OF VTE: ELECTIVE TOTAL HIP OR TOTAL KNEE REPLACEMENT SURGERY The recommended dose of ELIQUIS is 2.5 mg taken twice daily. The initial dose should be taken 12 to 24 hours after surgery. In patients undergoing hip replacement surgery, the recommended d Citiți documentul complet