7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United KingdomTelephone +4+4infww© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.EMA/486934/2006EMEA/V/C/042EPAR summary for the publicEconorValnemulinThis document 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 document 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 available as a premix for medicated feedingstuff for pigs, and as an oral powder for pigs. The premix is mixed into pig feed by an authorised feed mill and the resulting “medicated feeding stuff” is then distributed to the farmer to treat a large number of pigs. The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.Econor premix contains the active substance valnemulin at 0.5%, 1%, 10%, and 50%. Not all concentrations may be available in each country.Econor oral powder contains the active substance valnemulin at 10%.What is Econor used for?Econor is an antibiotic.It is used in pigs to treat and / or to prevent a number of infectious diseases that are caused by bacteria and affect the lungs (i.e. Swine Enzootic Pneumonia) or the intestinal tract (i.e. Swine Dysentery, Porcine Proliferative Enteropathy (ileitis) or Porcine Colonic Spirochaetosis (colitis)).Econor improves the health and weight of the treated pigs, but may not eliminate completely the bacteria that caused lung infection.Econor is mixed into pig food. The dose and length of treatment depends on the condition for whichit is being used. 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 in the bacteria’s ribosomes and inhibits the growth of bacteria. Valnemulin is active against a range of bacteria including those responsible for the intestinal and respiratory 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.The efficacy of Econor in the claimed indications was investigated in challenge studies (i.e. pigswere 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 historyof repeatedly re-occurring disease.During the clinical trials, pigs were only fed with medicated feedingstuff containing valnemulin in different concentrations (depending on the disease) for up to 4 weeks (depending on the disease). Efficacy of Econor was compared with the efficacy of an oral treatment with other antibiotics approved in the EU for the indication or with animals that did not receive any medication.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 3-4mg valnemulin/kg bodyweight/day (i.e. 75 mg/kg feed) for at least 7 days successfully treatedswine dysentery. Econor at a dose of 1-1.5 mg valnemulin/kg bodyweight/day (i.e. 25mg/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 adose 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.EconorPage 2/3EconorPage 3/3In the prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1-1.5mg 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.What are the side effects of Econor?Serious adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace. Extreme care should, therefore, be taken when using Econor in pigs of Scandinavian origin.Affected pigs are pyrexic (have a high temperature), have 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.What are the precautions for the person who gives the medicine or comes into contact with the animal?Avoid direct contact with the skin, mouth and nose when mixing Econor and handling the final feed.Econor has been developed especially for pigs and is not for use in humans. However, if Econor is accidentially consumed by a person, seek medical advice immediately and show the product label. People known to be allergic to valnemulin should use Econor with caution.What is the time to allow before treated pigs can be slaughtered and the meat used for human consumption (withdrawal period)?After the last administration of Econor (in the feed), pigs should not be slaughtered for one day.Why has Econor been approved?The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Econor are greater than any risks to prevent or treat a range of intestinal and respiratory diseases in pigs. The Committee recommended that Econor should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.Other information about Econor:The European Commission granted a marketing authorisation valid throughout the European Union, for Econor to Novartis Animal Health Austria GmbH on 14 October 1998. Information on the prescription status of this product may be found on the label of the carton.This summary was last updated on 06.01.2011.。