国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
racekadotril
Laboratoires GERDA
A07XA04
racekadotril
30 mg
Granulat till oral suspension
sackaros Hjälpämne; racekadotril 30 mg Aktiv substans
Receptbelagt
Avregistrerad
2019-10-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Racecadotril Gerda 10 mg Granules for Oral Suspension Racecadotril Gerda 30 mg Granules for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg sachet contains 10 mg of racecadotril and 979.8 mg of sucrose Each 30 mg sachet contains 30 mg of racecadotril and 2.9 g of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Racecadotril Gerda is administered via the oral route, together with oral rehydration (see section 4.4). 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. Racecadotril Gerda 10 mg: Racecadotril Gerda 10 mg is intended for children ≤ 13 kg. Infants weighing up to 9kg: one 10 mg dose sachet 3 times a day Infants weighing from 9kg to 13kg: two 10 mg dose sachet 3 times a day Racecadotril Gerda 30 mg: Children weighing from 13 kg to 27 kg: one 30 mg sachet 3 times daily. Children weighing 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. There are no clinical trials in infants under 3 months of age. Special populations: There are no studies in infants or children with renal impairment or hepatic impairment (see Section 4.4). Caution is advised in patients with hepatic or renal impairment. 完全なドキュメントを読む