Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
CLOMETHIAZOLE EDISILATE
AstraZeneca UK Limited
CLOMETHIAZOLE EDISILATE
8mg/ml Mg/Ml
Solution for Infusion
Withdrawn
2007-03-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Heminevrin 0.8% Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 8 mg/ml Clomethiazole edisilate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Heminevrin is a short acting hypnotic and sedative with anticonvulsant effect used for the treatment of: pre-eclamptic toxaemia, eclampsia, acute withdrawal symptoms in alcoholics and drug addiction in hospital where oral administration is not practicable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use. When Heminevrin is given by i.v. infusion, the dosage should always be controlled by the desired effect and the patient's response. Exact recommendations on dosage cannot be given because of individual patient variation and the presence or absence of other CNS depressant drugs such as diazepam, paraldehyde or alcohol. The doses given below therefore are guides only and due account must be taken of the patient's age (i.e. children and the very elderly), the general condition and any previous medication. In general, the infusion should be given as a loading dose to produce the required effect, followed by a maintenance dose. As is the case with intravenous anaesthetics, Heminevrin's brief action is due to redistribution of the drug and not to rapid elimination. Thus stopping the drug, will allow rapid reversal of its sedative effect initially but after large and prolonged dosage, recovery may be considerably delayed. The patient should be closely and constantly observed. Pre-eclamptic toxaemia Heminevrin is used to sedate the patient and raise the threshold for eclamptic convulsions. It is indicated in moderate or severe pre-eclamptic toxaemia under the following circumstance Preberite celoten dokument