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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

HYPNOMIDATE Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Hypnomidate 2 mg/ml Injection.

Qualitative and quantitative composition

Each ml of Hypnomidate contains etomidate 2 mg.

Pharmaceutical form

Solution for injection.

Therapeutic indications

Hypnomidate is an intravenous induction agent of anaesthesia.

Posology and method of administration

For intravenous administration. Hypnomidate should be injected slowly by the intravenous route. The product must only be used by physicians trained in endotracheal intubation. Equipment for artificial ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Warnings: In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate or sedative agents, the dose of etomidate should be reduced. Induction with Hypnomidate may be accompanied ...

Interaction with other medicinal products and other forms of interaction

The hypnotic effect of etomidate may be enhanced by neuroleptic drugs, opioids, sedatives and alcohol. Induction with etomidate may be accompanied by a slight and transient reduction in peripheral resistance ...

Fertility, pregnancy and lactation

Pregnancy In animals, no primary embryotoxic or teratogenic effects were observed with etomidate. Safety in human pregnancy has not been established. Hypnomidate should be used during pregnancy only if ...

Effects on ability to drive and use machines

Etomidate has a major influence on the ability to drive and use machines. Even though a patient may regain normal alertness 30 to 60 minutes after awakening, it is recommended that patients do not drive ...

Undesirable effects

The safety of Hypnomidate was evaluated in 812 subjects who participated in 4 open-label clinical trials of Hypnomidate used for the induction of general anaesthesia. These subjects took at least one dose ...

Overdose

Symptoms Overdosing is likely to result in prolonged anaesthesia with the possibility of respiratory depression and even arrest, in which case adequate respiratory support is mandatory. Hypotension has ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other general anesthetics ATC code: N01AX07 Etomidate is a short acting intravenous hypnotic which is rapidly inactivated by enzyme metabolism so that it does not give rise to ...

Pharmacokinetic properties

Profile in Plasma After intravenous administration, the time-course of the etomidate plasma levels can be described by a three-compartment model reflecting distribution, metabolism, and elimination processes. ...

Preclinical safety data

In a reproductive fertility study, results showed no effects on fertility or general pregnancy parameters, and no signs of embryotoxicity or teratogenicity. In standard embryotoxicity and teratology studies, ...

List of excipients

Propylene glycol Water for injections 1N sodium hydroxide* 1N hydrochloric acid* * for occasional pH adjustment only

Incompatibilities

Combinations with pancuronium bromide may show a very slight opalescence; for this reason the two should not be mixed together.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Colourless glass ampoule, Ph.Eur. Type I, containing 10 ml Hypnomidate, in packs of 5 and 10 ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom, Tel: 00441670562400

Marketing authorization number(s)

PL 37071/0006

Date of first authorization / renewal of the authorization

27 October 1978/20 March 2004

Date of revision of the text

09/2018

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