Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
ETOMIDATE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
N01AX07
EMULSION FOR INJECTION
ETOMIDATE 20 MG / 10 ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
ETOMIDATE
ETOMIDATE
Induction of general anaesthesia.
2019-04-30
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 Đọc toàn bộ tài liệu