देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Alimemazine tartrate
Primegen Limited
Alimemazine tartrate
1.5mg
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 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 ______________________________________________________________________________________ पूरा दस्तावेज़ पढ़ें