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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/166222/2011

EMEA/V/C/002009

EPAR summary for the public

Zuprevo

tildipirosin

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 Zuprevo?

Zuprevo is a veterinary medicine that contains tildipirosin. Zuprevo is available as a solution for injection containing tildipirosin 40 mg/ml (for pigs) or 180 mg/ml (for cattle).

What is Zuprevo used for?

Zuprevo is an antibiotic used in pigs to treat swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis. During severe outbreaks of SRD Zuprevo can also be used metaphylactically which means to treat at the same time both diseased pigs and those clincially healthy pigs in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.

Zuprevo is used in cattle to treat and prevent bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Zuprevo should only be used when the bacteria are sensitive to tildipirosin. When used to prevent BRD, the presence of the disease in the herd should be confirmed before use.

Zuprevo is given as a single injection, into muscle for pigs, and under the skin for cattle. The dose to use is calculated according to the animal's weight. The animal should be monitored and if signs of respiratory problems are still present after two days (pigs) or two to three days (cattle), the treatment should be switched to another antibiotic.

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When using the antibiotic Zuprevo, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance. Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.

This means that the antibiotic may no longer work on bacteria infecting either animals or humans.

How does Zuprevo work?

Zuprevo is an antibiotic that belongs to the group 'macrolides'. It works by blocking the bacterias' ribosomes, the parts of the cell where proteins are produced, and blocking the growth of bacteria.

How has Zuprevo been studied?

Laboratory as well as field studies were conducted to look at the use of Zuprevo in both the treatment and metaphylaxis of SRD and the treatment and prevention of BRD. In the field studies, the medicine was compared with other antibiotics used in these diseases (tulathromycin or florfenicol). The studies in SRD included pigs between three and 21 weeks of age, and those in BRD included cattle between one and 24 months of age. The treatment studies looked at the improvement of the signs of respiratory disease and the prevention studies looked at the absence of signs of infection (fever, respiratory or behaviour abnormalities) in animals exposed to infection.

The effectiveness of Zuprevo used for treatment and metaphylaxis of SRD in diseased pigs as well as in clinically healthy in-contact pigs was investigated in a field study in which an outbreak of SRD was confirmed with at least 30% of the pens showing clinical signs of SRD, including at least 10% of animals per pen within 1 day or 20% within 2 days or 30% within 3 days. 229 pigs were treated with Zuprevo and 227 pigs were untreated controls that received saline.

What benefit has Zuprevo shown during the studies?

The effectiveness of Zuprevo was shown to be comparable to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD.

When Zuprevo was used for treatment and metaphylaxis of SRD in diseased and clinically healthy incontact pigs approximately 86% of the healthy pigs remained free of clinical signs of disease compared with approximately 65% of pigs in the untreated control group.

What is the risk associated with Zuprevo?

Animals treated with Zuprevo may develop a swelling at the site of the injection, especially when larger volumes are used, therefore each injection is limited to a maximum volume (5 ml in pigs and 10 ml in cattle). The swelling can last for up to three days in pigs, and one to two weeks in cattle. Cattle may also experience pain at the time of injection.

Zuprevo should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics or to any of the excipients. The medicine should not be given into a blood vessel.

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

Tildipirosin may cause sensitisation by skin contact. In case of accidental contact, the skin should be washed immediately with soap and water, and the eyes flushed with clean water. Special caution should be taken to avoid accidental self-injection, as laboratory studies in dogs showed cardiovascular effects after intramuscular injection of high doses of tildipirosin. In case of accidental self-injection,

medical advice should be sought immediately and the package leaflet or the label should be shown to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.

The withdrawal period for meat is nine days for pigs and 47 days for cattle. This medicine is not allowed to be used in animals producing milk for human consumption.

Why has Zuprevo been approved?

The CVMP concluded that the benefits of Zuprevo outweigh the risks for the approved indications and recommended that Zuprevo be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Zuprevo:

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

This summary was last updated in February 2015.

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Zuprevo

EMA/166222/2011