SevoFlo

sevoflurane

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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 and cats. SevoFlo is used both to initiate and maintain general anaesthesia (loss of consciousness). 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 or cat 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 or cat is given a mixture of oxygen and sevoflurane to breathe, the sevoflurane is inhaled into its lungs and is carried by the blood into the brain. It causes unconsciousness by attaching to and activating receptors for GABA, a substance involved in reducing brain activity. Sevoflurane also blocks receptors for glutamate, a substance which increases activity in the brain. The combined action 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 in dogs found that SevoFlo was as effective at starting and maintaining anaesthesia as other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam. SevoFlo produced a relatively rapid and smooth start of anaesthesia in dogs, followed by a good recovery. Studies showed that sevoflurane could be used safely with several other medicines commonly used in dogs before or during operations, for maintenance of anaesthesia.

For cats, a review of published scientific literature showed that SevoFlo is effective for anaesthesia and that it is compatible with a range of sedative and pain-relieving medicines used in anaesthesia. The effectiveness of SevoFlo was comparable to isoflurane. In addition, since SevoFlo has been commonly used off-label (use that is not officially authorised) as an anaesthetic for cats for more than 10 years, its use in cats is ‘well-established’.

What are the risks associated with SevoFlo?

The most common side effects with SevoFlo, which may affect more than 1 in 10 animals, are low blood pressure, rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches and vomiting.

SevoFlo must not be given to animals with a genetic susceptibility to malignant hyperthermia. This is a rare life-threatening condition usually triggered by exposure to certain general anaesthetics that is associated with muscle spasm and very high body temperatures.

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.

If a person accidentally inhales sevoflurane vapour, this may cause symptoms such as shivering, nausea, headache, 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 any contact with the product by mouth must be avoided. Pregnant and breast-feeding women must not come into contact with the product and they should also avoid operating rooms and animal recovery areas where the product is being used 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 2018-01-18
SevoFlo : EPAR - Summary for the public ES = español 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public CS = čeština 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public DA = dansk 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public DE = Deutsch 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public ET = eesti keel 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public EL = elliniká 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public EN = English 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public FR = français 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public IT = italiano 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public LV = latviešu valoda 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public LT = lietuvių kalba 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public HU = magyar 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public MT = Malti 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public NL = Nederlands 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public PL = polski 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public PT = português 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public RO = română 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public SK = slovenčina 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public SL = slovenščina 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public FI = suomi 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public SV = svenska 2007-08-14 2018-01-18
SevoFlo : EPAR - Summary for the public HR = Hrvatski 2007-08-14 2018-01-18

This EPAR was last updated on 18/01/2018 .

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 DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QN01AB08







Publication details

Publication details for SevoFlo
Marketing-authorisation holder

Zoetis Belgium SA

Revision15
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

14/11/2017  SevoFlo -EMEA/V/C/000072 -II/0020

Name Language First published Last updated
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - Product Information HR = Hrvatski 2008-08-11 2018-01-18

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 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18
SevoFlo : EPAR - All Authorised presentations HR = Hrvatski 2008-08-11 2018-01-18

Pharmacotherapeutic group

Inhalation anaesthetic

Therapeutic indication

For the induction and maintenance of anaesthesia in dogs and cats.

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 2018-01-18
SevoFlo-V-C-72-II-0020 : EPAR - Assessment Report - Variation HR = Hrvatski 2018-01-18  

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