ISOFLURANE Inhalation vapour (2019)
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Περιεχόμενα
Name of the medicinal product
ISOFLURANE 100% Inhalation vapour, liquid.
Qualitative and quantitative composition
Isoflurane, 100% active.
Pharmaceutical form
Inhalation vapour, liquid.
Therapeutic indications
Isoflurane is general inhalation anaesthetic for use in induction and maintenance.
Posology and method of administration
Posology MAC values for Isoflurane vary with age. The table below indicates average MAC values for different age groups. <strong>ADULTS*:</strong> AGE Average MAC value In 100% Oxygen 70% N<sub>2</sub> ...
Contraindications
Isoflurane is contraindicated in patients with known sensitivity to Isoflurane or to other halogenated anaesthetics. It is also contraindicated in patients with known or suspected genetic susceptibility ...
Special warnings and precautions for use
Vaporisers specially calibrated for isoflurane should be used so that the concentration of anaesthetic delivered can be accurately controlled. Hypotension and respiratory depression increase as anaesthesia ...
Interaction with other medicinal products and other forms of interaction
Combinations advised against Beta-sympathomimetic agents like isoprenaline, and alpha and beta- sympathomimetic agents like adrenaline and noradrenaline should be used with caution during isoflurane narcosis, ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of isoflurane in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Isoflurane should only be used during ...
Effects on ability to drive and use machines
Patients should be advised that performance of activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, may be impaired for 2-4 days after anaesthesia with isoflurane. ...
Undesirable effects
a. Summary of the safety profile Adverse reactions encountered in the administration of Isoflurane are in general dose dependent extensions of pharmaco-physiological effects and include hypotension, respiratory ...
Overdose
As with other halogenated anaesthetics, hypotension and respiratory depression have been observed. Close monitoring of blood pressure and respiration is recommended. Supportive measures may be necessary ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nervous system; anaesthetic; general; Halogenated hydrocarbons ATC code: N01AB06 Isoflurane is a general inhalational anaesthetic which provides rapid induction of anaesthesia ...
Pharmacokinetic properties
MAC (Minimum Alveolar Concentration in man): Age 100% Oxygen 70%N~2~O 26 ± 4 1.28 0.56 44 ± 7 1.15 0.50 64 ± 5 1.05 0.37
Preclinical safety data
Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis ...
List of excipients
None.
Incompatibilities
Isoflurane has been reported to interact with dry carbon dioxide absorbents to form carbon monoxide. In order to minimise the risk of formation of carbon monoxide in rebreathing circuits and the possibility ...
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C. Keep the container tightly closed. Keep out of the sight and reach of children.
Nature and contents of container
Amber glass Type III nominal 100 ml or 250 ml bottle with black screw cap and polyethylene cone.
Special precautions for disposal and other handling
Vaporisers specially calibrated for isoflurane should be used so that the concentration of anaesthetic delivered can be accurately controlled. It is recommended that vapour from this and other inhalation ...
Marketing authorization holder
Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
Marketing authorization number(s)
PL 37071/0002
Date of first authorization / renewal of the authorization
1 February 1999 / 16<sup>th</sup> April 2002
Date of revision of the text
14/03/2019
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