Shop from the world's largest selection and best deals for Wedding Supplies. Shop with confidence on eBay! Discover your next essential device in our full range of tablets at Tesco direct. Browse online and choose from brands such as Apple, Samsung and Amazon. All the sale and clearance items from Argos, updated daily. Most popular deal on this page: Lenovo Tab A10-30 10.1 Inch 16GB Tablet - Blue. Nutritional Support for General Well-Being. Shop antique, mid-century, modern, contemporary and vintage furniture from the world's best furniture dealers. Global shipping available. Xarelto 20mg film-coated tablets - Summary of Product Characteristics (SPC) by Bayer Limited. Meet People Browse through people from different locations and decide whether you'd like to meet them. Selections See who wants to meet up with you, who you want to. Xarelto 2. 0mg film- coated tablets - Summary of Product Characteristics (SPC)Pharmacotherapeutic group: Direct factor Xa inhibitors, ATC code: B0. AF0. 1 Mechanism of action. Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated. Pharmacodynamic effects. Dose- dependent inhibition of factor Xa activity was observed in humans. Prothrombin time (PT) is influenced by rivaroxaban in a dose dependent way with a close correlation to plasma concentrations (r value equals 0. Neoplastin is used for the assay. Other reagents would provide different results. The readout for PT is to be done in seconds, because the INR (International Normalised Ratio) is only calibrated and validated for coumarins and cannot be used for any other anticoagulant. In patients receiving rivaroxaban for treatment of DVT and PE and prevention of recurrence, the 5/9. PT (Neoplastin) 2 - 4 hours after tablet intake (i. At trough (8 - 1. In patients with non- valvular atrial fibrillation receiving rivaroxaban for the prevention of stroke and systemic embolism, the 5/9. PT (Neoplastin) 1 - 4 hours after tablet intake (i. At trough (1. 6 - 3. In a clinical pharmacology study on the reversal of rivaroxaban pharmacodynamics in healthy adult subjects (n=2. IU/kg) of two different types of PCCs, a 3- factor PCC (Factors II, IX and X) and a 4- factor PCC (Factors II, VII, IX and X) were assessed. The 3- factor PCC reduced mean Neoplastin PT values by approximately 1. PCC. In contrast, the 3- factor PCC had a greater and more rapid overall effect on reversing changes in endogenous thrombin generation than the 4- factor PCC (see section 4. The activated partial thromboplastin time (a. PTT) and Hep. Test are also prolonged dose- dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine. However, if clinically indicated rivaroxaban levels can be measured by calibrated quantitative anti- factor Xa tests (see section 5. Clinical efficacy and safety. Lenovo Tablet Philippines Lenovo Tablet for sale at Lazada.com.ph 2016 Price List Best Brands Latest Tablet Online Reviews Effortless Shopping! Widest Range of Branded Tablets At Lazada Malaysia Designed for the serious athlete, Orange Triad delivers! Serious athletes are unique in that they intentionally subject their bodies to incredible amounts of stress. Prevention of stroke and systemic embolism in patients with non- valvular atrial fibrillation. The Xarelto clinical program was designed to demonstrate the efficacy of Xarelto for the prevention of stroke and systemic embolism in patients with non- valvular atrial fibrillation. In the pivotal double- blind ROCKET AF study, 1. Xarelto 2. 0 mg once daily (1. INR of 2. 5 (therapeutic range 2. The median time on treatment was 1. III antiarrhythmic including amiodarone. Xarelto was non- inferior to warfarin for the primary composite endpoint of stroke and non- CNS systemic embolism. In the per- protocol population on treatment, stroke or systemic embolism occurred in 1. HR 0. 7. 9; 9. 5% CI, 0. P< 0. 0. 01 for non- inferiority). Among all randomised patients analysed according to ITT, primary events occurred in 2. HR 0. 8. 8; 9. 5% CI, 0. P< 0. 0. 01 for non- inferiority; P=0. Results for secondary endpoints as tested in hierarchical order in the ITT analysis are displayed in Table 3. Among patients in the warfarin group, INR values were within the therapeutic range (2. The effect of rivaroxaban did not differ across the level of centre TTR (Time in Target INR Range of 2. P=0. 7. 4 for interaction). Within the highest quartile according to centre, the hazard ratio with rivaroxaban versus warfarin was 0. CI, 0. 4. 9 - 1. 1. The incidence rates for the principal safety outcome (major and non- major clinically relevant bleeding events) were similar for both treatment groups (see Table 4). Table 3: Efficacy results from phase III ROCKET AFStudy population. ITT analyses of efficacy in patients with non- valvular atrial fibrillation. Treatment dosage. Xarelto. 20 mg od (1. Event rate (1. 00 pt- yr)Warfarintitrated to a target INR of 2. Event rate (1. 00 pt- yr)Hazard ratio (9. CI)p- value, test for superiority. Stroke and non- CNS systemic embolism. Stroke, non- CNS systemic embolism and vascular death. Stroke, non- CNS systemic embolism, vascular death and myocardial infarction. Stroke. 25. 3(1. 9. Non- CNS systemic embolism. Myocardial infarction. Table 4: Safety results from phase III ROCKET AFStudy population. Patients with non- valvular atrial fibrillationa)Treatment dosage Xarelto. Event rate (1. 00 pt- yr)Warfarintitrated to a target INR of 2. Event rate (1. 00 pt- yr)Hazard ratio (9. CI)p- value Major and non- major clinically relevant bleeding events. Major bleeding events. Death due to bleeding*2. Critical organ bleeding*9. Intracranial haemorrhage*5. Haemoglobin drop*3. Transfusion of 2 or more units of packed red blood cells or whole blood*1. Non- major clinically relevant bleeding events. All cause mortality. Safety population, on treatment* Nominally significant. In addition to the phase III ROCKET AF study, a prospective, single- arm, post- authorization, non- interventional, open- label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted. CNS) systemic embolism in clinical practice. The mean CHADS2 and HAS- BLED scores were both 2. XANTUS, compared to a mean CHADS2 and HAS- BLED score of 3. ROCKET AF, respectively. Major bleeding occurred in 2. Fatal haemorrhage was reported in 0. Stroke or non- CNS systemic embolism was recorded in 0. These observations in clinical practice are consistent with the established safety profile in this indication. Patients undergoing cardioversion. A prospective, randomized, open- label, multicenter, exploratory study with blinded endpoint evaluation (X- VERT) was conducted in 1. VKA (randomized 2: 1), for the prevention of cardiovascular events. TEE- guided (1 - 5 days of pre- treatment) or conventional cardioversion (at least three weeks of pre- treatment) strategies were employed. The primary efficacy outcome (all stroke, transient ischemic attack, non- CNS systemic embolism, MI and cardiovascular death) occurred in 5 (0. VKA group (n = 4. RR 0. 5. 0; 9. 5 % CI 0. ITT population). The principal safety outcome (major bleeding) occurred in 6 (0. VKA (n = 4. 99) groups, respectively (RR 0. CI 0. 2. 1- 2. 6. This exploratory study showed comparable efficacy and safety between rivaroxaban and VKA treatment groups in the setting of cardioversion. Treatment of DVT, PE and prevention of recurrent DVT and PE The Xarelto clinical program was designed to demonstrate the efficacy of Xarelto in the initial and continued treatment of acute DVT and PE and prevention of recurrence. Over 9,4. 00 patients were studied in three randomised controlled phase III clinical studies (Einstein DVT, Einstein PE and Einstein Extension) and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted. The overall combined treatment duration in all studies was up to 2. In Einstein DVT 3,4. DVT were studied for the treatment of DVT and the prevention of recurrent DVT and PE (patients who presented with symptomatic PE were excluded from this study). The treatment duration was for 3, 6 or 1. For the initial 3 week treatment of acute DVT 1. This was followed by 2. In Einstein PE, 4,8. PE were studied for the treatment of PE and the prevention of recurrent DVT and PE. The treatment duration was for 3, 6 or 1. For the initial treatment of acute PE 1. This was followed by 2. In both the Einstein DVT and the Einstein PE study, the comparator treatment regimen consisted of enoxaparin administered for at least 5 days in combination with vitamin K antagonist treatment until the PT/INR was in therapeutic range (. Treatment was continued with a vitamin K antagonist dose- adjusted to maintain the PT/INR values within the therapeutic range of 2. In Einstein Extension 1,1. DVT or PE were studied for the prevention of recurrent DVT and PE. The treatment duration was for an additional 6 or 1. Xarelto 2. 0 mg once daily was compared with placebo. All phase III studies used the same pre- defined primary and secondary efficacy outcomes. The primary efficacy outcome was symptomatic recurrent VTE defined as the composite of recurrent DVT or fatal or non- fatal PE. The secondary efficacy outcome was defined as the composite of recurrent DVT, non- fatal PE and all cause mortality. In the Einstein DVT study (see Table 5) rivaroxaban was demonstrated to be non- inferior to enoxaparin/VKA for the primary efficacy outcome (p < 0. The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a hazard ratio of 0. CI: 0. 4. 7 – 0. 9. INR values were within the therapeutic range a mean of 6. In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2. VTE (P=0. 9. 32 for interaction). Within the highest tertile according to centre, the hazard ratio with rivaroxaban versus warfarin was 0. CI: 0. 3. 5 - 1. 3. The incidence rates for the primary safety outcome (major or clinically relevant non- major bleeding events) as well as the secondary safety outcome (major bleeding events) were similar for both treatment groups. Table 5: Efficacy and safety results from phase III Einstein DVTStudy population. Treatment dosage and duration. Xareltoa)3, 6 or 1. N=1,7. 31. Enoxaparin/VKAb)3, 6 or 1. N=1,7. 18. Symptomatic recurrent VTE*3. Symptomatic recurrent PE2. Symptomatic recurrent DVT1. Symptomatic PE and DVT1(0. Fatal PE/Death where PE cannot be ruled out. Major or clinically relevant non- major bleeding. Major bleeding events. Rivaroxaban 1. 5 mg twice daily for 3 weeks followed by 2. Enoxaparin for at least 5 days, overlapped with and followed by VKA* p < 0.
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