Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Rivaroxaban micronized
BAYER (SOUTH EAST ASIA) PTE LTD
B01AF01
GRANULE, FOR SUSPENSION
Rivaroxaban micronized 1.0mg/ml
ORAL
Prescription Only
Bayer AG, Leverkusen
ACTIVE
2022-05-06
Xarelto Oral Suspension PI_CCDS 4_Dec 2022 1. NAME OF THE MEDICINAL PRODUCT Xarelto 1 mg/mL granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The granules contain 19.7 mg rivaroxaban per gram. Each bottle contains 51.7 mg rivaroxaban or 103.4 mg rivaroxaban. Following reconstitution the oral suspension contains 1 mg rivaroxaban per mL. Excipient with known effect Each mL of the reconstituted oral suspension contains 1.8 mg sodium benzoate (E 211), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension White granules 4. CLINICAL PARTICULARS 4.1 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose and frequency of administration are determined based on body weight (see Table 1). Xarelto Oral Suspension PI_CCDS 4_Dec 2022 TABLE 1: RECOMMENDED DOSE FOR XARELTO IN PAEDIATRIC PATIENTS FROM FULL-TERM NEONATES (FOLLOWING AT LEAST 10 DAYS OF ORAL FEEDING AND WEIGHING AT LEAST 2.6 KG) TO CHILDREN LESS THAN 18 YEARS OF AGE BODYWEIGHT [KG] REGIMEN DOSE RIVAROXABAN TOTAL DAILY DOSE SUITABLE BLUE SYRINGE (1 MG RIVAROXABAN CORRESPONDS TO 1 ML OF THE SUSPENSION) MIN MAX ONCE A DAY 2 TIMES A DAY 3 TIMES A DAY 2.6 < 3 0.8 mg 2.4 mg 1 mL 3 < 4 0.9 mg 2.7 mg 1 mL 4 < 5 1.4 mg 4.2 mg 5 mL 5 < 7 1.6 mg 4.8 mg 5 mL 7 < 8 1.8 mg 5.4 mg 5 mL 8 < 9 2.4 mg 7.2 mg 5 mL 9 < 10 2.8 mg 8.4 mg 5 mL 10 < 12 3.0 mg 9.0 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 Baca dokumen lengkap