Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
HALOPERIDOL
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
2 Mg/Ml
Unknown
1991-12-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serenace 2 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of solution contains 2 mg haloperidol. Excipients: Methyl parahydroxybenzoate (E218) 0.5 mg/ml. Propyl parahydroxybenzoate (E216) 0.05 mg/ml. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless, odourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Recommended use For the management of cases of schizophrenia, hypomania, mania, agitation, psychotic illness, paranoid psychosis, childhood behaviour disorders especially associated with problems in mentally retarded, and severe motor tics and Gilles de la Tourette Syndrome, intractable hiccup, control of severe nausea and vomiting excluding that of hyperemesis gravidarum. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults The usual initial dose is 1.5 to 20mg daily depending on the individual patient’s characteristics and the severity of the disorder, with increments until optimum response is obtained. Reduction of the dosage can then be made to the usual maintenance dose of 3 to 10mg daily. Elderly In the elderly, half the above doses are usually sufficient. Maximum and maintenance doses will usually be lower for geriatric and debilitated patients because of greater sensitivity. Gilles de la Tourette Syndrome The usual initial dose is 2mg daily with increments to the level of optimal control, generally 6 to 50mg followed by a gradual reduction to a maintenance level, which is generally around 4mg. Children An initial dosage of 0.025 to 0.05mg/kg body weight can be used with a maximum of 10mg daily, with a subsequent maintenance level of 0.05mg/kg body weight. The higher dose levels generally should be combined with anti Läs hela dokumentet