Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
HALOPERIDOL
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
HALOPERIDOL
5 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-04-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serenace 5 mg/ml Ampoule Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 5 mg of haloperidol. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, sterile, aqueous solution with a pH of 3.0 - 3.4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Psychotic disorders – schizophrenia, mania and hypomania, especially paranoid psychoses. Mental or behavioural problems such as aggression, hyperactivity and self-mutilation in the mentally retarded. Moderate to severe psychomotor agitation _eg _severe motor tics and Gilles de la Tourette Syndrome, excitement, and violent or dangerously impulsive behaviour. Nausea, vomiting and intractable hiccup. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION There is considerable variation from patient to patient in the response to treatment and the dosage required. As with all antipsychotics, dosage should be individualised according to the needs and response of each patient. To determine the initial dosage, consideration should be given to the patient’s age, severity of symptoms and previous response to other antipsychotic therapy. Oral dosage may be given in single or divided doses. Administration twice daily is sufficient in most cases. ADULTS Psychotic behaviour; mental or behavioural problems; moderate to severe psychomotor agitation or impulsive behaviour; mania and hypomania. INITIAL TREATMENT For the control of acutely agitated patients showing moderate symptoms an intramuscular injection of 2 – 10mg may be given. Depending on the response of the patient subsequent doses may be given every 4 – 8 hours up to a maximum of 18mg/day. Infrequently, severely disturbed patients may require an Belgenin tamamını okuyun