LARGACTIL 25 Mg/Ml Solution for Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

CHLORPROMAZINE HYDROCHLORIDE

זמין מ:

May & Baker Limited

INN (שם בינלאומי):

CHLORPROMAZINE HYDROCHLORIDE

כמות:

25 Mg/Ml

טופס פרצבטיות:

Solution for Injection

מצב אישור:

Withdrawn

תאריך אישור:

2007-01-10

מאפייני מוצר

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�