Exzolt

fluralaner

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This is a summary of the European public assessment report (EPAR) for Exzolt.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Exzolt.

For practical information about using Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Exzolt and what is it used for?

Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens. Poultry red mite is a parasite that feeds on the blood of hens. Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts). Egg production may also be affected. Exzolt contains the active substance fluralaner.

How is Exzolt used?

Exzolt is available as a solution for use in drinking water and can only be obtained with a prescription. Exzolt is added to drinking water on two occasions, seven days apart. Sufficient Exzolt is added to ensure the required dose is present in the volume of water that the chickens will consume in one day. If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.

For further information, see the package leaflet.

How does Exzolt work?

The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide’. This means it kills parasites such as mites that feed on the skin of animals. Fluralaner kills mites by acting on their nervous system after they have ingested the chicken’s blood. It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.

What benefits of Exzolt have been shown in studies?

Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house. One of the houses on each of the farms was treated with Exzolt, the other house was left untreated. Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers. The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.

What are the risks associated with Exzolt?

There are no known side effects. For the full list of restrictions, see the package leaflet.

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

Safety information has been included in the summary of product characteristics and the package leaflet for Exzolt, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

Since the veterinary medicine may be slightly irritating to skin and/or eyes, contact with skin, eyes and mucous membranes (moist body surfaces, such as the lining of the mouth) should be avoided. While handling the product people must not eat, drink or smoke. Hands and contacted skin should be washed after use of the medicine.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before eggs may be used for human consumption.

The withdrawal period for meat from chickens treated with Exzolt is 14 days.

The withdrawal period for eggs from chickens treated with Exzolt is ‘zero’ days, which means there is no mandatory waiting time.

Why is Exzolt approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Exzolt

The European Commission granted a marketing authorisation valid throughout the EU for Exzolt on 18 August 2017.

For more information about treatment with Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Exzolt : EPAR - Summary for the public BG = bălgarski 2017-10-20  
Exzolt : EPAR - Summary for the public ES = español 2017-10-20  
Exzolt : EPAR - Summary for the public CS = čeština 2017-10-20  
Exzolt : EPAR - Summary for the public DA = dansk 2017-10-20  
Exzolt : EPAR - Summary for the public DE = Deutsch 2017-10-20  
Exzolt : EPAR - Summary for the public ET = eesti keel 2017-10-20  
Exzolt : EPAR - Summary for the public EL = elliniká 2017-10-20  
Exzolt : EPAR - Summary for the public EN = English 2017-10-20  
Exzolt : EPAR - Summary for the public FR = français 2017-10-20  
Exzolt : EPAR - Summary for the public IT = italiano 2017-10-20  
Exzolt : EPAR - Summary for the public LV = latviešu valoda 2017-10-20  
Exzolt : EPAR - Summary for the public LT = lietuvių kalba 2017-10-20  
Exzolt : EPAR - Summary for the public HU = magyar 2017-10-20  
Exzolt : EPAR - Summary for the public MT = Malti 2017-10-20  
Exzolt : EPAR - Summary for the public NL = Nederlands 2017-10-20  
Exzolt : EPAR - Summary for the public PL = polski 2017-10-20  
Exzolt : EPAR - Summary for the public PT = português 2017-10-20  
Exzolt : EPAR - Summary for the public RO = română 2017-10-20  
Exzolt : EPAR - Summary for the public SK = slovenčina 2017-10-20  
Exzolt : EPAR - Summary for the public SL = slovenščina 2017-10-20  
Exzolt : EPAR - Summary for the public FI = suomi 2017-10-20  
Exzolt : EPAR - Summary for the public SV = svenska 2017-10-20  
Exzolt : EPAR - Summary for the public HR = Hrvatski 2017-10-20  

This EPAR was last updated on 20/10/2017 .

Authorisation details

Product details

Product details for Exzolt
NameExzolt
Agency product numberEMEA/V/C/004344
Active substance

fluralaner

International non-proprietary name (INN) or common name

fluralaner

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes QP53BE02



Publication details

Publication details for Exzolt
Marketing-authorisation holder

Intervet International B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/08/2017

Contact address:

Intervet International B.V.
Wim de Körverstraat 35 5831 AN 
Boxmeer 
Netherlands
 

Product information

Product information

18/08/2017  Exzolt -EMEA/V/C/004344

Name Language First published Last updated
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  
Exzolt : EPAR - Product Information HR = Hrvatski 2017-10-20  

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
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  
Exzolt : EPAR - All Authorised presentations HR = Hrvatski 2017-10-20  

Pharmacotherapeutic group

Ectoparaciticides, insecticides and repellents

Therapeutic indication

Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Exzolt : EPAR - Public assessment report HR = Hrvatski 2017-10-20  
CVMP summary of positive opinion for Exzolt HR = Hrvatski 2017-06-16