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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/486934/2006

EMEA/V/C/042

EPAR summary for the public

Econor

Valnemulin

This 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 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 enteropathy or 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.

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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 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.

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 - 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 7 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 and/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.

Econor

Other information about Econor:

The European Commission granted a marketing authorisation valid throughout the European Union, for Econor 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 in June 2013

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Econor

EMA/486934/2006