Halocur

halofuginone

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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 Halocur?

Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa. Halocur is presented as a clear, yellow solution for administration by mouth.

What is Halocur used for?

Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum. This is a parasite belonging to the ‘protozoa’ family that invades the digestive system causing diarrhoea.

Halocur can be used:

  • to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with Cryptosporidium), when it is given to newborn calves in the first 24 to 48 hours of life;
  • to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.

In all cases, Halocur is given to the calf by mouth after a feed, not on an empty stomach, once a day for seven consecutive days.

How does Halocur work?

The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum. It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces. This contributes to the spread of the disease to other animals. Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea. The exact way halofuginone works is unknown.

How has Halocur been studied?

A number of field trials were performed involving calves from different farms. In one trial, calves were included from 40 farms. Treatment with the recommended dose of Halocur orally during seven consecutive days, in calves aged from four to 10 days was shown to reduce diarrhoea compared to placebo. Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.

What benefit has Halocur shown during the studies?

Halocur treatment was shown to reduce the level of excretion of Cryptosporidium parvum by the calves and to reduce diarrhoea. It was also shown to prevent diarrhoea following 11 days of treatment.

These studies compared treatment with Halocur to placebo. Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.

What is the risk associated with Halocur?

Symptoms of toxicity may occur if Halocur is administered at twice the recommended dose. Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse. Halocur should not be administered to calves in cases where diarrhoea has been established for more than 24 hours, or to weak animals. Halocur should be given after feeding.

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

People who handle Halocur repeatedly may develop skin allergies. Users should avoid skin and eye contact with the product and if such contact happens, they should wash the exposed area thoroughly with clean water. If eye irritation persists, medical advice should be sought. Protective gloves should be worn while handling the product and hands should be washed after use.

Halocur should not enter watercourses as this may be dangerous for fish and other aquatic organisms.

Any unused product or waste materials should be disposed of in accordance with local requirements.

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

13 days.

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

Not applicable since the product is only to be used in newborn calves.

Why has Halocur been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves. They recommended that Halocur be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Halocur:

The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B.V. on 29 October 1999. The marketing authorisation was renewed on 29 October 2004. Information on the prescription status of this product may be found on the label of the bottle.

Name Language First published Last updated
Halocur : EPAR - Summary for the public BG = bălgarski 2007-08-08  
Halocur : EPAR - Summary for the public ES = español 2007-08-08  
Halocur : EPAR - Summary for the public CS = čeština 2007-08-08  
Halocur : EPAR - Summary for the public DA = dansk 2007-08-08  
Halocur : EPAR - Summary for the public DE = Deutsch 2007-08-08  
Halocur : EPAR - Summary for the public ET = eesti keel 2007-08-08  
Halocur : EPAR - Summary for the public EL = elliniká 2007-08-08  
Halocur : EPAR - Summary for the public EN = English 2007-08-08  
Halocur : EPAR - Summary for the public FR = français 2007-08-08  
Halocur : EPAR - Summary for the public IT = italiano 2007-08-08  
Halocur : EPAR - Summary for the public LV = latviešu valoda 2007-08-08  
Halocur : EPAR - Summary for the public LT = lietuvių kalba 2007-08-08  
Halocur : EPAR - Summary for the public HU = magyar 2007-08-08  
Halocur : EPAR - Summary for the public MT = Malti 2007-08-08  
Halocur : EPAR - Summary for the public NL = Nederlands 2007-08-08  
Halocur : EPAR - Summary for the public PL = polski 2007-08-08  
Halocur : EPAR - Summary for the public PT = português 2007-08-08  
Halocur : EPAR - Summary for the public RO = română 2007-08-08  
Halocur : EPAR - Summary for the public SK = slovenčina 2007-08-08  
Halocur : EPAR - Summary for the public SL = slovenščina 2007-08-08  
Halocur : EPAR - Summary for the public FI = suomi 2007-08-08  
Halocur : EPAR - Summary for the public SV = svenska 2007-08-08  

This EPAR was last updated on 04/12/2009 .

Authorisation details

Product details

Product details for Halocur
NameHalocur
Agency product numberEMEA/V/C/000040
Active substance

halofuginone

International non-proprietary name (INN) or common name

halofuginone

Species Calves, newborn
Anatomical therapeutic chemical veterinary (ATCvet) codeQP51AX08

Publication details

Publication details for Halocur
Marketing-authorisation holder

Intervet International BV

Revision7
Date of issue of marketing authorisation valid throughout the European Union29/10/1999

Contact address:

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

Product information

Product information

23/11/2009  Halocur -EMEA/V/C/000040 -R/0006

Name Language First published Last updated
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  
Halocur : EPAR - Product Information SV = svenska 2009-12-04  

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
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  
Halocur : EPAR - All Authorised presentations SV = svenska 2007-08-08  

Pharmacotherapeutic group

Antiprotozoals

Therapeutic indication

In newborn calves

Prevention of diarrhoea due to diagnosed Cryptosporidium parvum in farms with history of cryptosporidiosis.

Administration should start in the first 24 to 48 hours of age.

Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.

Administration should start within 24 hours after the onset of diarrhoea.

In both cases, the reduction of oocyst excretion has been demonstrated.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Halocur : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-12-04  

Initial marketing-authorisation documents

Name Language First published Last updated
Halocur : EPAR - Scientific Discussion SV = svenska 2008-10-07  
Halocur : EPAR - Procedural steps taken before authorisation SV = svenska 2005-11-22