SevoFlo

sevoflurane

  • Email
  • Help

About

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 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 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.

For more information about treatment with SevoFlo, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
SevoFlo : EPAR - Summary for the public BG = bălgarski 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public ES = español 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public CS = čeština 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public DA = dansk 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public DE = Deutsch 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public ET = eesti keel 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public EL = elliniká 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public EN = English 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public FR = français 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public IT = italiano 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public LV = latviešu valoda 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public LT = lietuvių kalba 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public HU = magyar 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public MT = Malti 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public NL = Nederlands 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public PL = polski 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public PT = português 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public RO = română 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public SK = slovenčina 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public SL = slovenščina 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public FI = suomi 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public SV = svenska 2007-08-14 2016-01-11
SevoFlo : EPAR - Summary for the public HR = Hrvatski 2007-08-14 2016-01-11

This EPAR was last updated on 06/04/2017 .

Authorisation details

Product details

Product details for SevoFlo
NameSevoFlo
Agency product numberEMEA/V/C/000072
Active substance

sevoflurane

International non-proprietary name (INN) or common name

sevoflurane

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QN01AB08






Publication details

Publication details for SevoFlo
Marketing-authorisation holder

Zoetis Belgium SA

Revision14
Date of issue of marketing authorisation valid throughout the European Union11/12/2002

Contact address:

Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  SevoFlo -EMEA/V/C/000072 -IA/0019/G

Name Language First published Last updated
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2017-04-06

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11  

Pharmacotherapeutic group

Nervous system

Therapeutic indication

For the induction and maintenance of anaesthesia in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
SevoFlo : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2008-08-28 2017-04-06

Initial marketing-authorisation documents

Name Language First published Last updated
SevoFlo : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-03  
SevoFlo : EPAR - Scientific Discussion HR = Hrvatski 2006-08-03