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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
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