ETOMIDATE-LIPURO 20MG/10ML INJ IN 10ML GA

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ETOMIDATE

Available from:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (International Name):

ETOMIDATE

Units in package:

10ml mL

Manufactured by:

B.BRAUN MELSUNGEN AG

Summary of Product characteristics

COMPOSITION
10 ml of emulsion contain
Etomidate
20 mg
_Excipients:_
Soya-bean oil, medium-chain triglycerides, glycerol, egg lecithin,
sodium
oleate, water for injections.
PHARMACEUTICAL FORM
Emulsion for injection in glass ampoules of 10 ml
PHARMACO-THERAPEUTIC GROUP
General anaesthetic
INDICATIONS
Induction of general anaesthesia
CONTRAINDICATIONS
Etomidate-®Lipuro must not be administered to patients with known hy-
persensitivity to etomidate, soya-bean oil or any other of the
constituents
of the product.
Etomidate has revealed porphyrogenic potential in animal experiments.
Therefore it should not be administered to patients with inherited
disorders
of haem biosynthesis, unless the indication for administration of
etomidate
has definitely been established after careful consideration of its
risks and
potential benefits.
Newborns and infants up to the age of 6 months should be excluded from
treatment with Etomidate-®Lipuro except for imperative indications
during
in-patient treatment.
Pregnancy, see section “Use in pregnancy and lactation” below.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Soya-bean oil may rarely cause severe allergic reactions.
After prolonged continuous administration of etomidate there is a risk
of
transient adrenocortical failure.
Etomidate-®Lipuro may be used only by a doctor skilled in
endotracheal
intubation, with equipment for artificial respiration being available.
Etomidate-®Lipuro has no analgesic effect. If used for short-term
narcosis,
a strong analgesic, e. g. fentanyl, must be given prior to or
simultaneously
with Etomidate-®Lipuro; attention should also be paid to further
informa-
tion given under “Interactions”.
_Effects on the ability to drive or to use machines:_
Even when Etomidate-®Lipuro is used as directed, patients having
received
this drug will not be able to drive or to use machines for at least 24
hours
after administration.
PREGNANCY AND LACTATION
Safety of the use of Etomidate-®Lipuro during pregnancy has not been
es-
tablished. Therefore, Etomidate-®Li