XARELTO GRANULES FOR ORAL SUSPENSION 1MGML

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Rivaroxaban micronized

Commercializzato da:

BAYER (SOUTH EAST ASIA) PTE LTD

Codice ATC:

B01AF01

Forma farmaceutica:

GRANULE, FOR SUSPENSION

Composizione:

Rivaroxaban micronized 1.0mg/ml

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Bayer AG, Leverkusen

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2022-05-06

Scheda tecnica

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