ETOMIDATE-LIPURO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ETOMIDATE

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

N01AX07

Pharmaceutical form:

EMULSION FOR INJECTION

Composition:

ETOMIDATE 20 MG / 10 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic group:

ETOMIDATE

Therapeutic area:

ETOMIDATE

Therapeutic indications:

Induction of general anaesthesia.

Authorization date:

2019-04-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etomidate-Lipuro
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of emulsion for injection contains
2 mg of etomidate
10 ml of emulsion for injection (= 1 ampoule) contain
20 mg of etomidate
Excipients with known effect:
One ampoule (10 ml) of emulsion for injection contains:
Soya-bean oil, refined
1.0 g
Sodium (as sodium oleate)
0.23 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Emulsion for injection.
Milky-white oil-in-water emulsion
pH
6.0 – 8.5
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Induction of general anaesthesia.
_ _
_Notice: _
For short-term narcosis, Etomidate-Lipuro must be combined with an
analgesic drug.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage is adjusted acc. to the individual response and the
clinical effect.
_The following dosage guidelines should be followed: _
As a rule, the effective hypnotic dose is between 0.15 and 0.3 mg of
etomidate per kg
body weight, corresponding to 0.075 to 0.15 ml of Etomidate-Lipuro per
kg body
weight.
Children up to the age of 15 and elderly patients are given a single
dose of 0.15 to 0.2
mg of etomidate, corresponding to 0.075 to 0.1 ml of Etomidate-Lipuro
per kg body
weight. Also in patients belonging to these age groups, the exact
dosage has to be
adjusted acc. to the clinical effect. In children up to the age of 15
the dosage may be
increased by up to 30 % of the adult dose because it is sometimes
necessary in order
to obtain the same depth and duration of sleep.
Since etomidate has no analgesic action, appropriate analgesics should
be used in
procedures involving painful stimuli.
Do not exceed a total dose of 30 ml (3 ampoules). Etomidate should
only be given by
slow intravenous injection.
In patients with liver cirrhosis and patients having been premedicated
with
neuroleptics opioids or sedatives the dose has to be reduced.
In the special case of narcosis to terminate a status epilepticus or
serial epileptic
seizures a sufficient d