Recuvyra

Fentanyl

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This is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Recuvyra?

Recuvyra is a medicine that contains the active substance fentanyl. It is available as a transdermal solution (a solution applied to the skin).

What is Recuvyra used for?

Recuvyra is used to control pain in dogs that have undergone major orthopaedic (bone) or soft tissue surgery. It is given by a veterinarian.

The recommended dose is 2.6 mg per kilogram bodyweight applied with a specially designed syringe to the skin between the shoulder blades of the dog. It is given once only, two to four hours before surgery, and its effects will last for at least four days.

How does Recuvyra work?

The active substance in Recuvyra, fentanyl, is an opioid painkiller. When applied to the skin of dogs, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels below the skin. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.

How has Recuvyra been studied?

In two main studies, dogs undergoing orthopaedic or soft tissue surgery were either given Recuvyra or buprenorphine (another opioid painkiller) in advance of surgery to control their pain. The studies compared the two medicines in terms of failure rate (dogs that had to be taken off treatment due to lack of pain control) and the need for additional treatment to counteract the harmful effects of opioid medicines.

What benefit has Recuvyra shown during the studies?

In both studies Recuvyra was as effective as the comparator medicine in treating pain in dogs following orthopaedic or soft tissue surgery.

What is the risk associated with Recuvyra?

Recuvyra very commonly causes sleepiness which may last for more than 24 hours after applying the medicine, and which can be associated with reduced food and water intake, decreased stool production and transient weight loss. Other side effects include mild reductions in body temperature, heart rate and breathing rate for up to three days following use. Diarrhoea and vomiting are also common side effects.

Recuvyra must not be use in dogs that are allergic to the active substance or any other ingredient. Recuvyra must not be used on skin that is broken or damaged due to injury or disease. 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?

The person administering Recuvyra should avoid contact with their skin as the medicine can be absorbed by human skin and may cause reactions in people, including skin irritation. If symptoms develop as a result of exposure to Recuvyra, medical advice should be sought immediately. The most common symptoms associated with fentanyl overdose in people include respiratory depression, sleepiness and myosis (narrowing of the pupil in the eye).Protective equipment of clothing should be used when handling the medicine.

Contact with the dog’s skin after application of Recuvyra should not cause problems for adults. However, small children (15kg or less) should not touch the dog for three days after the medicine has been applied, as they may be exposed to a large amount of fentanyl.

Why has Recuvyra been approved?

Recuvyra was shown to be as effective as the comparator medicines with the added advantage of being easy to apply. The CVMP decided that the benefits of Recuvyra outweighed its risks and recommended that it be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Recuvyra:

The European Commission granted a marketing authorisation valid throughout the European Union, for Recuvyra on 6 October 2011. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Recuvyra : EPAR - Summary for the public BG = bălgarski 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public ES = español 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public CS = čeština 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public DA = dansk 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public DE = Deutsch 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public ET = eesti keel 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public EL = elliniká 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public EN = English 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public FR = français 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public IT = italiano 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public LV = latviešu valoda 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public LT = lietuvių kalba 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public HU = magyar 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public MT = Malti 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public NL = Nederlands 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public PL = polski 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public PT = português 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public RO = română 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public SK = slovenčina 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public SL = slovenščina 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public FI = suomi 12/10/2011 21/03/2012
Recuvyra : EPAR - Summary for the public SV = svenska 12/10/2011 21/03/2012

This EPAR was last updated on 18/06/2014 .

Authorisation details

Product details

Product details for Recuvyra
NameRecuvyra
Agency product numberEMEA/V/C/002239
Active substance

Fentanyl

International non-proprietary name (INN) or common name

Fentanyl

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQN02AB03

Publication details

Publication details for Recuvyra
Marketing-authorisation holder

Eli Lilly and Company Limited
 

Revision2
Date of issue of marketing authorisation valid throughout the European Union06/10/2011

Contact address:

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire
UK-RG24 9NL

Product information

Product information

28/05/2014  Recuvyra -EMEA/V/C/002239 -IG/0437

Name Language First published Last updated
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012
Recuvyra : EPAR - Product Information SV = svenska 12/10/2011 21/03/2012

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
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  
Recuvyra : EPAR - All Authorised presentations SV = svenska 12/10/2011  

Pharmacotherapeutic group

Nervous system

Therapeutic indication

For the control of pain associated with orthopaedic and soft tissue surgery in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Recuvyra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 21/03/2012 18/06/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Recuvyra : EPAR - Public assessment report SV = svenska 12/10/2011  
CVMP summary of positive opinion for Recuvyra SV = svenska 06/05/2011 12/05/2011