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For patients with body weight less 30 kg refer to the Summary of Product Characteristics of Xarelto granules for oral suspension. This is the maximum daily dose.Ī once daily dose of 15 mg rivaroxaban is recommended. The dose for children and adolescent is calculated based on body weight.Ī once daily dose of 20 mg rivaroxaban is recommended. Xarelto treatment in children and adolescents aged less than 18 years should be initiated following at least 5 days of initial parenteral anticoagulation treatment (see section 5.1). Treatment of VTE and prevention of VTE recurrence in children and adolescents The dose should not be doubled within the same day to make up for a missed dose. If a dose is missed during the once daily treatment phase, the patient should take Xarelto immediately, and continue on the following day with the once daily intake as recommended. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day. In this case two 15 mg tablets may be taken at once. If a dose is missed during the 15 mg twice daily treatment phase (day 1 - 21), the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day.
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To support the dose switch from 15 mg to 20 mg after Day 21 a first 4 weeks treatment initiation pack of Xarelto for treatment of DVT/PE is available. Treatment and prevention of recurrent DVT and PEįollowing completion of at least 6 months therapy for DVT or PE The duration of therapy and dose selection should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4). In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Xarelto 10 mg once daily, a dose of Xarelto 20 mg once daily should be considered. When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily. Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE. Short duration of therapy (at least 3 months) should be considered in patients with DVT or PE provoked by major transient risk factors (i.e. The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE in adults If a dose is missed the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended. Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4). The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Prevention of stroke and systemic embolism in adults Date of first authorisation/renewal of the authorisation 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.
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