Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Racecadotril
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
A07XA04
30.00mg
GRANULE, FOR SUSPENSION
Racecadotril 30.00mg
ORAL
Prescription Only
Laboratoires Sophartex
ACTIVE
2013-09-30
Updated 25 Sep 2014 Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT Hidrasec Infants Granules for Oral Suspension 10 mg Hidrasec Children Granules for Oral Suspension 30 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Hidrasec Infants contains 10 mg of racecadotril. Each sachet of Hidrasec Children contains 30 mg of racecadotril. Excipients with known effect Each sachet Hidrasec Infants contains 0.966 g of sucrose. Each sachet Hidrasec Children contains 2.9 g of sucrose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Granules for oral suspension. White powder with apricot smell. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hidrasec Infants10mg, Hidrasec Children 30mg: Complementary, symptomatic treatment of acute diarrhoea in infants (older than 3 months) and children, when oral rehydration and usual support measures are insufficient to control the clinical condition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hidrasec Infants 10mg and Hidrasec Children 30mg are administered via the oral route, together with oral rehydration (see section 4.4). Hidrasec Infants 10mg is intended for children < 13kg. Hidrasec Children 30mg is intended for children ≥ 13kg. The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals. In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily. Updated 25 Sep 2014 Page 2 of 6 The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal s Lugege kogu dokumenti
Updated 17 August 2017 Page 1 of 7 1. NAME OF THE MEDICINAL PRODUCT Hidrasec Infants Granules for Oral Suspension 10 mg Hidrasec Children Granules for Oral Suspension 30 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Hidrasec Infants contains 10 mg of racecadotril. Each sachet of Hidrasec Children contains 30 mg of racecadotril. Excipients with known effect Each sachet Hidrasec Infants contains 0.966 g of sucrose. Each sachet Hidrasec Children contains 2.9 g of sucrose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Granules for oral suspension. White powder with apricot smell. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hidrasec Infants10mg, Hidrasec Children 30mg: Complementary, symptomatic treatment of acute diarrhoea in infants (older than 3 months) and children, when oral rehydration and usual support measures are insufficient to control the clinical condition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hidrasec Infants 10mg and Hidrasec Children 30mg are administered via the oral route, together with oral rehydration (see section 4.4). Hidrasec Infants 10mg is intended for children < 13kg. Hidrasec Children 30mg is intended for children ≥ 13kg. The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals. In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily. The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days. Long term treatment with racecadotril is not recommended. There are no clinical trials in infants under 3 months of age. Updated 17 August 2017 Page 2 of 7 _Special populations_ : There are no studies in infants or children with renal impair Lugege kogu dokumenti