国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Alimemazine tartrate
Primegen Limited
R06AD01
Alimemazine tartrate
6mg
Syrup
Oral use
100ml bottle
Product subject to prescription which may be renewed (B)
Phenothiazine derivatives
It has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. It may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years
Authorised
2015-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine tartrate 30mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml dose contains 6mg of Alimemazine tartrate. Also contains Sucrose 680 mg/ml Sodium sulphite anhydrous (E221) 1.0 mg/ml Sodium metabisulphite (E223) 1.0 mg/ml Ethanol 40.2 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup. Clear, colourless to pale yellow, syrupy liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. Alimemazine tartrate 7.5mg / 5ml syrup should be used for this indication in children. Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years. Alimemazine tartrate 30 mg / 5ml syrup can be used for the specific indication of pre-anaesthesia sedation in children (see Section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Alimemazine is not recommended for children less than 2 years old. Do NOT exceed the recommended dose (see also section 4.9). _Urticaria and pruritus_ Adults and adolescents 12-17 years: 10mg (approx. 1.6ml) two or three times daily. Elderly: Dosage should be reduced to 10mg (approx. 1.6ml) once or twice daily. Children less than 12 years of age should be prescribed alimemazine in a lower strength (7.5 mg/5 ml) syrup formulation for the indication of urticaria and pruritus. _As a sedative before anaesthesia_ (Children aged 2-7 years:) the maximum dosage recommended is 2mg (approx. 0.33 ml) per kg bodyweight 1-2 hours HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/07/2015 完全なドキュメントを読む