Zuprevo

tildipirosin

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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 Zuprevo?

Zuprevo is a 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?

Zuprevois 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.

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 bacteria's ribosomes, the parts of the cell where proteins are produced, and inhibiting the growth of bacteria.

How has Zuprevo been studied?

Laboratory as well as field studies were conducted out to look at the use of Zuprevo in both the treatment and prevention of SRD and 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.

What benefit has Zuprevo shown during the studies?

The efficacy of Zuprevo was shown to be noninferior to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD. The studies regarding prevention of SRD were not conclusive, which prevented the CVMP from accepting the indication.

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.

During the studies in pigs, two out of just over 1,000 animals treated suffered from shock (a steep fall in blood pressure). While one animal recovered quickly, the other one died.

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 time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is nine days for pigs and 47 days for cattle.

What is the time to allow before milk can be taken from the animal for human consumption?

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 treatment of SRD and for the treatment and prevention of BRD, when associated with bacteria sensitive to tildipirosin, 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 to Intervet International BV on 6 May 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Zuprevo : EPAR - Summary for the public BG = bălgarski 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public ES = español 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public CS = čeština 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public DA = dansk 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public DE = Deutsch 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public ET = eesti keel 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public EL = elliniká 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public EN = English 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public FR = français 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public IT = italiano 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public LV = latviešu valoda 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public LT = lietuvių kalba 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public HU = magyar 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public MT = Malti 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public NL = Nederlands 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public PL = polski 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public PT = português 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public RO = română 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public SK = slovenčina 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public SL = slovenščina 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public FI = suomi 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public SV = svenska 2011-05-23 2015-08-12
Zuprevo : EPAR - Summary for the public HR = Hrvatski 2011-05-23 2015-08-12

This EPAR was last updated on 25/04/2016 .

Authorisation details

Product details

Product details for Zuprevo
NameZuprevo
Agency product numberEMEA/V/C/002009
Active substance

tildipirosin

International non-proprietary name (INN) or common name

tildipirosin

Species PigsCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQJ01FA

Publication details

Publication details for Zuprevo
Marketing-authorisation holder

Intervet International BV

Revision4
Date of issue of marketing authorisation valid throughout the European Union06/05/2011

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

22/03/2016  Zuprevo -EMEA/V/C/002009 -R/0010

Name Language First published Last updated
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25
Zuprevo : EPAR - Product Information HR = Hrvatski 2011-05-23 2016-04-25

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
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  
Zuprevo : EPAR - All Authorised presentations HR = Hrvatski 2011-05-23  

Pharmacotherapeutic group

General anti-infectives for systemic use

Therapeutic indication

40-mg/ml solution for injection for pigs

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.

The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.

180-mg/ml solution for injection for cattle

For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.

The presence of the disease in the herd should be confirmed before preventive treatment.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zuprevo : EPAR - Public assessment report HR = Hrvatski 2011-05-23  
CVMP summary of positive opinion for Zuprevo HR = Hrvatski 2011-03-11