Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
Kinedexe UK Limited
R06AD01
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
30 MG/5ml
Syrup
Product subject to prescription which may be renewed (B)
Phenothiazine derivatives
Authorised
2015-08-28
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 30/11/2016 Belgenin tamamını okuyun