Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
Kinedexe UK Limited
R06AD01
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
7.5 MG/5ml
Syrup
oral use
100ml
Product subject to prescription which may be renewed (B)
: Phenothiazine derivatives
Phenothiazine derivatives
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
Authorised
2015-09-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine tartrate 7.5mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml dose contains 1.5mg 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 Not recommended for infants less than 2 years old. Do NOT exceed the recommended dose (see also section 4.9). Children over 2 years of age: _Urticaria and pruritus_ Aged 2 – 5 years: 2.5mg (1.7ml) three to four times per day Aged 5 – 12 years: 5mg (3.3ml) three to four times per day As a sedative before anaesthesia (Children aged 2-7 years:) the maximum dosage recommended is 2mg (approx. 1.3ml) per kg bodyweight 1-2 hours before the operation. For the indication of sedation prior to anaesthesia, which requires a once only, high dose of alimemazine, the higher strength (30mg/5ml) syrup should be prescribed in order to limit ethanol exposure (see Section 4.4). HEALTH PRODUCTS REGULATORY AUTHORITY ______________________________________________________________________________________ Perskaitykite visą dokumentą