XARELTO

Posology The dose and frequency of administration are determined based on body weight (see Table 1). 0 mg 5 mL 12 < 30 5 mg 10 mg 5 mL or 10 mL 30 < 50 15 mg 15 mg 10 mL ≥ 50 20 mg 20 mg 10 mL The weight of the child should be monitored and the dose reviewed regularly, especially for children below 12 kg.

This is to ensure that a therapeutic dose is maintained. Dose adjustments should be made based on changes in body weight only. Frequency of dosing: • For a once a day regimen The doses should be taken approximately 24 hours apart. • For a two times a day regimen The doses should be taken approximately 12 hours apart.

• For a three times a day regimen The doses should be taken approximately 8 hours apart. 6 kg to less than 30 kg only the oral suspension should be used. Do not split Xarelto tablets or use Xarelto tablets of lower strength in an attempt to provide doses for children with body weight below 30 kg.

For patients with body weight of at least 30 kg, Xarelto oral suspension or tablets of 15 mg or 20 mg strength can be administered once a day. Xarelto oral suspension is provided with either 1 mL or 5 mL and 10 mL blue syringes (oral dosing syringe) with their adapter.

5 mL graduations) for patients weighing 12 kg or more For patients weighing 12 kg up to less than 30 kg, either 5 mL or 10 mL blue syringes can be used. It is recommended that the healthcare professional advises the patient or caregiver which blue syringe to use to ensure that the correct volume is administered.

Instructions for Use booklet is provided with the medicinal product. 1). Xarelto is dosed based on body weight using the oral suspension formulation (see Table 1). 1). Xarelto is dosed based on body weight (see Table 1). Duration of treatment • All children, except those aged less than 2 years with catheter-related thrombosis Therapy should be continued for at least 3 months.

Treatment can be extended up to 12 months when clinically necessary. There is no data available in children to support a dose reduction after 6 months treatment. The benefit-risk of continued therapy after 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk.

• Children aged less than 2 years with catheter-related thrombosis Therapy should be continued for at least 1 month. Treatment can be extended up to 3 months when clinically necessary. The benefit-risk of continued therapy after 1 month should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk.

Summary of the safety profile The safety of rivaroxaban has been evaluated in thirteen pivotal phase III studies (see Table 1). Overall, 69,608 adult patients in nineteen phase III studies and 488 paediatric patients in two phase II and two phase III studies were exposed to rivaroxaban.

4. and ‘Description of selected adverse reactions’ below) (Table 2). 8 %). 74 per 100 patient years*** # * For all rivaroxaban studies all bleeding events are collected, reported and adjudicated. ** In the COMPASS study, there is a low anaemia incidence as a selective approach to adverse event collection was applied *** A selective approach to adverse event collection was applied # From the VOYAGER PAD study Tabulated list of adverse reactions The frequencies of adverse reactions reported with Xarelto in adult and paediatric patients are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.

Frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) rare (≥ 1/10,000 to < 1/1,000) very rare (< 1/10,000) not known (cannot be estimated from the available data) Table 3: All adverse reactions reported in adult patients in phase III clinical studies or through post-marketing use* and in two phase II and two phase III studies in paediatric patients Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Anaemia (incl.

respective laboratory parameters) Thrombocytosis (incl. platelet count increased)A, thrombocytopenia Immune system disorders Allergic reaction, dermatitis allergic, angioedema and allergic oedema Anaphylactic reactions including anaphylactic shock Nervous system disorders Dizziness, headache Cerebral and intracranial haemorrhage, syncope Eye disorders Eye haemorrhage (incl.

conjunctival haemorrhage) Cardiac disorders Tachycardia Vascular disorders Hypotension, haematoma Respiratory, thoracic and mediastinal disorders Epistaxis, haemoptysis Eosinophilic pneumonia Gastrointestinal disorders Gingival bleeding, gastrointestinal tract haemorrhage (incl.

4. 1. 1 Therapeutic indications Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.

2 Posology and method of administration Posology The dose and frequency of administration are determined based on body weight (see Table 1). 0 mg 5 mL 12 < 30 5 mg 10 mg 5 mL or 10 mL 30 < 50 15 mg 15 mg 10 mL ≥ 50 20 mg 20 mg 10 mL The weight of the child should be monitored and the dose reviewed regularly, especially for children below 12 kg.

This is to ensure that a therapeutic dose is maintained. Dose adjustments should be made based on changes in body weight only. Frequency of dosing: • For a once a day regimen The doses should be taken approximately 24 hours apart. • For a two times a day regimen The doses should be taken approximately 12 hours apart.

• For a three times a day regimen The doses should be taken approximately 8 hours apart. 6 kg to less than 30 kg only the oral suspension should be used. Do not split Xarelto tablets or use Xarelto tablets of lower strength in an attempt to provide doses for children with body weight below 30 kg.

For patients with body weight of at least 30 kg, Xarelto oral suspension or tablets of 15 mg or 20 mg strength can be administered once a day. Xarelto oral suspension is provided with either 1 mL or 5 mL and 10 mL blue syringes (oral dosing syringe) with their adapter.

5 mL graduations) for patients weighing 12 kg or more For patients weighing 12 kg up to less than 30 kg, either 5 mL or 10 mL blue syringes can be used. It is recommended that the healthcare professional advises the patient or caregiver which blue syringe to use to ensure that the correct volume is administered.

Instructions for Use booklet is provided with the medicinal product. 1). Xarelto is dosed based on body weight using the oral suspension formulation (see Table 1). 1). Xarelto is dosed based on body weight (see Table 1). Duration of treatment • All children, except those aged less than 2 years with catheter-related thrombosis Therapy should be continued for at least 3 months.

1. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

g. 5). 2). 6).