Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CHLORPROMAZINE HYDROCHLORIDE
May & Baker Limited
CHLORPROMAZINE HYDROCHLORIDE
25 Mg/Ml
Solution for Injection
Withdrawn
2007-01-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Largactil Injection 2.5% - 2 ml ampoule. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorpromazine hydrochloride 50 mg/2ml (25 mg/ml) For excipients, see 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clean, clear solution, colour not deeper than pale yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Largactil is indicated in the following: (i) In the management of anxiety and tension states, agitation, depression, behavioural disturbances and subnormality. (ii) In the management of schizophrenia and other psychoses including mania and hypomania, and psychopathy, and in the control of the central effects of such drugs as LSD. (iii) In the management of terminal illness, senile irritability, intractable hiccup, eclampsia and pre-eclampsia. (iv) As a pre- and post-anaesthetic, medication, an adjunct to facilitation of anaesthesia, and induction of hypothermia. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Route of administration: Deep intramuscular injection. Oral administration should be used whenever possible. Parenteral formulations may be used in emergencies. They may only be administered by deep intramuscular injection. Largactil is too irritant to give subcutaneously. Repeated injections should be avoided if possible. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 03/08/2005_ _CRN 2012321_ _page number: 1_ Table1: Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety and agitation etc. Table 2: Hiccups, Induction of hypothermia _Route _ _Adult _ _Children _ _under 1 _ _year _ _Children 1 -5 _ _years _ _Children 6-12 _ _years _ _Elderly or _ _debilitated patients _ Oral Initially 25 mg t.d.s. or 75 mg at bedtime increasing by daily amounts of Baca dokumen lengkap