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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/CVMP/92087/2007

EMEA/V/C/000072

EPAR summary for the public

SevoFlo

sevoflurane

This is a summary of the European public assessment report (EPAR) for SevoFlo. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use SevoFlo.

For practical information about using SevoFlo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is SevoFlo and what is it used for?

SevoFlo is a general anaesthetic for dogs. SevoFlo is used both to cause and maintain general anaesthesia (loss of consciousness) in dogs. It contains the active substance sevoflurane, a chemical which is a liquid at room temperature, but when heated becomes a gas (vaporises).

For further information, see the package leaflet.

How is SevoFlo used?

SevoFlo is given using specialised anaesthetic equipment, usually in a carefully controlled gas mixture including oxygen. The dog breathes in the gas mixture, which causes it to become unconscious. The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does SevoFlo work?

When a dog is given a mixture of oxygen and sevoflurane to breathe, the sevoflurane is inhaled into its lungs, from where it goes into the blood stream, crosses into the brain where it causes unconsciousness by binding and activating receptors for GABA, a substance involved in reducing electrical activity in the brain. Sevoflurane also binds and blocks receptors for glutamate which is a

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substance which increases electrical activity in the brain. By acting on these receptors sevoflurane increases GABA's effects whilst reducing glutamate's effects and so reduces the level of consciousness.

What benefits of SevoFlo have been shown in studies?

Studies were carried out in dogs, comparing the effectiveness of SevoFlo to that of other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam, and SevoFlo's effectiveness at both causing and maintaining anaesthesia was investigated. In the studies, SevoFlo was equally effective when compared to other anaesthetic agents. SevoFlo was shown to produce a relatively rapid and smooth induction of anaesthesia in dogs, followed by a good recovery. Studies showed that sevoflurane could be used safely for maintenance of anaesthesia with several other medicines commonly used in dogs before or during operations.

What is are the risks associated with SevoFlo?

SevoFlo must not be given to pregnant or lactating bitches. Neither must it be given to dogs with a known or suspected genetic susceptibility to malignant hyperthermia. This is a rare life-threatening condition associated with a very high temperature usually triggered by exposure to certain general anaesthetics. SevoFlo must also not be given to puppies less than 12 weeks of age.

The most common side effects with SevoFlo are low blood pressure, abnormally rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches and vomiting.

For the full list of all side effects reported with SevoFlo, and for the full list of restrictions see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for SevoFlo, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

This veterinary medicine has been developed especially for dogs and is not intended for use in humans.

If a person accidentally inhales sevoflurane vapour, this may cause symptoms such as shivering, nausea, headaches, low blood pressure, decreased heart rate and even reduced breathing. Care must therefore be taken when handling Sevoflo: any spillage must be removed immediately, the vapour must not be inhaled, and all contact with the product by mouth must be avoided. Pregnant and breast-feeding women must not come into contact with the product and should also avoid operating rooms and animal recovery areas where the product is being, or has recently been, used. In case of accidental contact with the skin or eyes, or for more information, the package leaflet should be consulted.

Why is SevoFlo approved?

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that SevoFlo's

SevoFlo

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benefits are greater that its risks and recommended that it be approved for use in the EU.

Other information about SevoFlo?

The European Commission granted a marketing authorisation valid throughout the EU for SevoFlo on 11 December 2002.

The full EPAR for SevoFlo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with SevoFlo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in September 2015.

SevoFlo

EMA/CVMP/92087/2007