Etomidate - Lipuro 20 mg/10 ml inj. emuls. i.v. amp.

Country: Belgium

Language: English

Source: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

Active ingredient:

Etomidate 20 mg/10 ml

Available from:

B. Braun Melsungen AG

ATC code:

N01AX07

INN (International Name):

Etomidate

Dosage:

20 mg/10 ml

Pharmaceutical form:

Emulsion for injection

Composition:

Etomidate 2 mg/ml

Administration route:

Intravenous use

Therapeutic area:

Etomidate

Product summary:

CTI code: 190233-01 - Pack size: 10 x 10 ml - Commercialisation status: YES - FMD code: 04030539040006 - CNK code: 1713056 - Delivery mode: Medical prescription; CTI code: 190233-02 - Pack size: 10 x 10 ml - Commercialisation status: NO - Delivery mode: Medical prescription

Authorization status:

Commercialised: Yes

Authorization date:

1998-01-19

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
_Notice:_
For short-term narcosis, Etomidate-Lipuro must be combined with an
analgesic drug.
CONTRAINDICATIONS
Etomidate-Lipuro must not be administered to patients with known
hypersensitivity to etomidate, soya-bean oil or any other of the
constituents
of the product.
Neonates 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
Etomidate has revealed a 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 defi nitely been established after careful consideration of its
risks and
potential benefi ts.
Especially when administered in high doses in combination with
centrally
depressant drugs, etomidate may cause transient anpnoea.
Soya-bean oil may rarely cause severe allergic reactions.
After prolonged continuous administration of etomidate there is a risk
of
transient adrenocortical failure. During longer lasting operations or
in the
case of impaired adrenocortical function prophylactic administration
of
cortisol may be needed, e.g. 50 - 100 mg of hydrocortisone.
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
information
given under “Interactions”.
_Effects on the ability to drive or to use machines:_
Even when Etomidate-Lipuro is used as directed, patients havi