Econor

valnemulin

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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 Econor?

Econor is a medicine that contains the active substance valnemulin. It is available as a premix for medicated feeding stuff for pigs (0.5%, 10% and 50%) and rabbits (10%), and as an oral powder for pigs (10%). Not all strengths may be available in every country.

What is Econor used for?

Econor is an antibiotic.

It is used in pigs to treat or prevent a number of infectious diseases that are caused by bacteria and affect the lungs (i.e. swine enzootic pneumonia) or the gut (i.e. swine dysentery, porcine proliferative enteropathyor porcine colonic spirochaetosis).

Econor improves the health and weight of the treated pigs, but may not completely eliminate the bacteria that cause lung infection.

In rabbits, Econor is used to reduce mortality during an outbreak of epizootic rabbit enteropathy (ERE). This is a disease associated with imbalance of the normal bacteria in the gut which leads to growth of clostridia, bacteria that produce a toxin which paralyses the intestine. ERE commonly occurs in commercial rabbit farms during the post-weaning fattening period.

Econor premix is mixed into pig or rabbit food by an authorised feed mill and the resulting 'medicated feeding stuff' is then distributed to the farmer to treat a large number of pigs or rabbits. The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs. The dose and length of treatment depends on the condition, the animal for which it is being used and its bodyweight. For details, please see the package leaflet.

How does Econor work?

The active substance of Econor is valnemulin, an antibiotic of the pleuromutilin group. It works by blocking the production of proteins inside the bacteria and thereby stopping their growth. Valnemulin is active against a range of bacteria including those responsible for the diseases listed above.

How has Econor been studied?

The antimicrobial effectiveness of valnemulin against bacteria causing the claimed diseases in pigs was studied in microbiological laboratories.

In pigs, the efficacy of Econor in the claimed indications was investigated in challenge studies (i.e. pigs were artificially infected with the bacteria) or in field studies (i.e. natural infections under farm conditions). The field studies were carried out on a large number of farms in various European countries involving various breeds and crossbreeds of pigs.

Econor was used either to treat animals that were already affected by a disease or to prevent the outbreak of the disease in pigs in contact with diseased animals as well as on farms with a history of repeatedly re-occurring disease.

During the clinical trials, pigs were only fed with medicated feeding stuff containing valnemulin in different concentrations (depending on the disease) for up to four weeks (depending on the disease). Efficacy of Econor was compared with the efficacy of an oral treatment with other antibiotics approved in the European Union (EU) for the indication or with animals that did not receive any medication.

In rabbits, Econor was investigated in a field study involving 1,152 weaned rabbits. Treatment with Econor at two different doses (20 and 35 mg valnemulin per kg of feed) for 21 days, started immediately after an outbreak of ERE, and was compared with no treatment. The main measure of effectiveness was the percentage of the rabbits that died as a result of ERE between days 0 and 28.

What benefit has Econor shown during the studies?

In the studies in the treatment and prevention of swine dysentery, Econor in feed at a dose of 3-4 mg valnemulin/kg bodyweight/day (i.e. 75 mg/kg feed) for at least sebem days successfully treated swine dysentery. Econor at a dose of 1-1.5 mg valnemulin/kg bodyweight/day (i.e. 25 mg/kg feed) effectively prevented the development of the disease.

In the studies in the treatment and prevention of swine enzootic pneumonia, Econor in feed at a dose of 10-12 mg valnemulin/kg bodyweight (i.e. 200 mg/kg feed) reduced lung lesions, improved clinical signs and pig growth rates. However, infection with Mycoplasma hyopneumoniae was not eliminated. 

In the prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1-1.5 mg valnemulin/kg bodyweight/day (i.e. 25 mg/kg feed) was effective in controlling the clinical signs and prevented weight loss caused by the disease in untreated pigs.

For the treatment of porcine proliferative enteropathy (ileitis), Econor in feed at a dose of 3-4 mg valnemulin/kg bodyweight/day (i.e. 75 mg/kg feed) for 10 days improved the clinical condition of the pigs, reduced diarrhoea and improved productivity.

In the study in rabbits mortality was reduced from 23% in untreated rabbits to 11% in those given 20 mg valnemulin per kg of feed, and about 8% in those given 35 mg valnemulin per kg feed. While Econor cannot prevent the outbreak of the disease, it had a positive effect in terms of reducing the severity of disease and improving its outcome.

What are the side effects of Econor?

In pigs, serious adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish or Swedish Landrace. Extreme care should, therefore, be taken when using Econor in pigs of Scandinavian origin.

The most common side effects in pigs are pyrexia (have a high temperature) and a lack of appetite; in severe cases they might become uncoordinated and remain lying down. Some pigs may also suffer oedema (swelling caused by fluid) or erythema (redness) on the hindquarters, and palpebral (eyelid) oedema.

If side effects occur, Econor containing food should be immediately removed; severely affected pigs should be moved to clean, dry pens and given appropriate treatment.

Tympanism (distension of the abdomen) is more frequent in rabbits treated with Econor than untreated rabbits.

Rabbits must not be given overdoses of Econor as this may disturb gastrointestinal flora (gut bacteria) leading to the development of enterotoxaemia (infection of the gut).

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

Gloves should be worn when handling the product. Direct contact with the skin, mouth and nose should be avoided when mixing Econor and handling the final feed.

If Econor is accidentially consumed by a person, medical advice should be sought immediately and the product label shown to the doctor. People known to be allergic to valnemulin should use Econor with caution.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. The withdrawal period for Econor for pig meat and offal is one day and for rabbit meat and offal zero days.

Why has Econor been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Econor exceed the risks for the approved indications. The Committee recommended that Econor should be given a marketing authorisation. The benefit / risk balance may be found in the scientific discussion module of this EPAR.

Other information about Econor

The European Commission granted a marketing authorisation valid throughout the EU for Econor on 14 October 1998. Information on the prescription status of this product may be found on the label of the carton.

Name Language First published Last updated
Econor : EPAR - Summary for the public BG = bălgarski 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public ES = español 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public CS = čeština 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public DA = dansk 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public DE = Deutsch 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public ET = eesti keel 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public EL = elliniká 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public EN = English 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public FR = français 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public IT = italiano 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public LV = latviešu valoda 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public LT = lietuvių kalba 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public HU = magyar 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public MT = Malti 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public NL = Nederlands 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public PL = polski 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public PT = português 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public RO = română 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public SK = slovenčina 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public SL = slovenščina 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public FI = suomi 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public SV = svenska 2007-02-12 2013-10-03
Econor : EPAR - Summary for the public HR = Hrvatski 2007-02-12 2013-10-03

This EPAR was last updated on 13/07/2017 .

Authorisation details

Product details

Product details for Econor
NameEconor
Agency product numberEMEA/V/C/000042
Active substance

valnemulin

International non-proprietary name (INN) or common name

valnemulin

Species PigsRabbits
Anatomical therapeutic chemical veterinary (ATCvet) codes QJ01XQ02








Publication details

Publication details for Econor
Marketing-authorisation holder

Elanco Europe Ltd.

Revision19
Date of issue of marketing authorisation valid throughout the European Union12/03/1999

Contact address:

Elanco Europe Ltd.
Lilly House, Priestley Road
Basingstoke RG24 9NL
United Kingdom

Product information

Product information

12/07/2017  Econor -EMEA/V/C/000042 -IB-0051

Name Language First published Last updated
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13
Econor : EPAR - Product Information HR = Hrvatski 2009-05-29 2017-07-13

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
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22
Econor : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2014-04-22

Pharmacotherapeutic group

Anti-infectives for systemic use, pleuromutilins

Therapeutic indication

Pigs

The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.

Rabbits

Reduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE). Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Econor : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Econor : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21