Convenia

cefovecin

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This is a summary of the European public assessment report (EPAR). 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 Convenia?

Convenia contains cefovecin, an antibiotic that is given by injection (under the skin). It is used for dogs and cats.

There are two vials in each pack of Convenia, one vial containing a powder, and one vial containing the diluent. The powder is dissolved in the diluent before use to make up a solution for injection.

What is Convenia used for?

Convenia is used to treat infections caused by certain specific bacteria (see the summary of product characteristics (SmPC) for further details). It is generally given as a single injection, and the effect of the injection lasts for up to 14 days. Depending on the infection concerned, the injection can be repeated if necessary (up to three times).

Convenia is used in dogs to treat skin and soft-tissue infections. These are infections on the skin and in the layers just below the skin, such as wounds, abscesses and pyoderma (a skin infection with a rash and pustules). It is also used in dogs to treat urinary-tract infections caused by certain specific bacteria.

Convenia is used in cats to treat skin and soft-tissue infections, such as wounds and abscesses. It is also used in cats to treat urinary-tract infections caused by certain specific bacteria. 

How does Convenia work?

The active substance in Convenia is cefovecin which belongs to a class of antibiotics called third-generation cephalosporins. All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured. Like other antibiotics, cefovecin is not effective against all types of bacteria.

Cefovecin differs from other similar cephalosporin antibiotics as it stays in the dog’s or cat’s body for a very long time after it has been injected. One injection lasts for up to 14 days.

How has Convenia been studied?

Data from laboratory studies with different bacteria showed that cefovecin was effective against the bacteria specified in the product information (SmPC and package leaflet).

Convenia has been studied in dogs with skin and soft-tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary-tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).

Convenia has also been studied in cats with skin and soft-tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid), and in a small study in cats with urinary-tract infections, where it was compared with cefalexin. The studies measured the rate at which the infections were cured.

What benefit has Convenia shown during the studies?

In all studies, Convenia was as effective in curing the infection as the comparator antibiotic. Convenia has the benefit of a long duration of activity.

What is the risk associated with Convenia?

No side effects have been reported with Convenia to date. However, it should not be used in dogs or cats that have shown an allergy to any cephalosporin or penicillin-type antibiotics.

Convenia should also not be used in dogs or cats of less than eight weeks old, or in dogs or cats with severe kidney problems (renal dysfunction).

It would be dangerous to use Convenia in other animals such as guinea pigs and rabbits (it is not licensed for use in these species). As no studies have been made in breeding animals with Convenia and it has an exceptionally long duration in the body, Convenia should not be used in pregnant or lactating dogs or cats. Treated animals should not be used for breeding for 12 weeks after the last injection of Convenia.

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

Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious. Convenia should therefore not be handled by anyone who is hypersensitive (allergic) to such antibiotics, or by anyone who has been advised not to work with them. Anyone allergic to penicillins or cephalosporins should also avoid contact with litter used by dogs or cats treated with Convenia.

Convenia should be handled with care and all the recommended precautions be taken to avoid exposure to the product. If any symptoms occur after accidental exposure to Convenia, for example a skin rash, then the advice of a doctor should be sought immediately. Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.

Why has Convenia been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft-tissue and urinary-tract infections and recommended that Convenia should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Convenia

The European Commission granted a marketing authorisation valid throughout the European Union for Convenia on 19 June 2006. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Convenia : EPAR - Summary for the public BG = bălgarski 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public ES = español 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public CS = čeština 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public DA = dansk 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public DE = Deutsch 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public ET = eesti keel 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public EL = elliniká 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public EN = English 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public FR = français 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public IT = italiano 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public LV = latviešu valoda 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public LT = lietuvių kalba 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public HU = magyar 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public MT = Malti 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public NL = Nederlands 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public PL = polski 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public PT = português 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public RO = română 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public SK = slovenčina 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public SL = slovenščina 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public FI = suomi 2007-09-05 2013-05-28
Convenia : EPAR - Summary for the public SV = svenska 2007-09-05 2013-05-28

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Convenia
NameConvenia
Agency product numberEMEA/V/C/000098
Active substance

cefovecin

International non-proprietary name (INN) or common name

cefovecin

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QJ01DD91







Publication details

Publication details for Convenia
Marketing-authorisation holder

Zoetis Belgium SA

Revision9
Date of issue of marketing authorisation valid throughout the European Union19/06/2006

Contact address:

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

Product information

Product information

23/03/2017  Convenia -EMEA/V/C/000098 -IG/0747

Name Language First published Last updated
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10
Convenia : EPAR - Product Information SV = svenska 2008-10-23 2017-04-10

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
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25
Convenia : EPAR - All Authorised presentations SV = svenska 2010-02-03 2012-05-25

Pharmacotherapeutic group

Antibacterials for systemic use (cephalosporins)

Therapeutic indication

Dogs

For the treatment of skin and soft-tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β-haemolytic streptococci, Escherichia coli and / or Pasteurella multocida.

For the treatment of urinary-tract infections associated with Escherichia coli and / or Proteus spp.

As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues associated with Porphyromonas spp. and Prevotella spp.

Cats

For the treatment of skin and soft-tissue abscesses and wounds associated with Pasteurella multocida, Usobacterium spp., Bacteroides spp., Prevotella oralis, β-haemolytic streptococci and / or Staphylococcus pseudintermedius.

For the treatment of urinary-tract infections associated with Escherichia coli.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Convenia : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-11-11 2017-04-10
CVMP post-authorisation summary of positive opinion for Convenia SV = svenska 2009-12-11  

Initial marketing-authorisation documents

Name Language First published Last updated
Convenia : EPAR - Procedural steps taken before authorisation SV = svenska 2007-09-05  
Convenia : EPAR - Scientific Discussion SV = svenska 2007-09-05