Halocur
Authorised
This medicine is authorised for use in the European Union
halofuginone
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Halocur is a veterinary medicine used to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum in newborn calves. C. parvum is a parasite belonging to the ‘protozoa’ family that invades the digestive system, causing diarrhoea. The infection is known as cryptosporidiosis.
The medicine contains the active substance halofuginone.
Halocur can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth). It is given to newborn calves once a day for one week. For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of the diarrhoea. Halocur should be given after feeding.
For more information about using Halocur, see the package leaflet or contact your veterinarian or pharmacist.
The active substance in Halocur, halofuginone, prevents the growth of C. parvum. It also limits the spread of the disease by preventing the formation of oocysts which are a stage in the lifecycle of the parasite that are passed in the faeces. The exact way halofuginone works is unknown.
A number of field trials were performed involving calves from different farms. In one trial, calves aged from 4 to 10 days from 40 farms were included. Treatment with Halocur during 7 consecutive days was shown to reduce diarrhoea and the level of excretion of C. parvum to a greater extent than placebo (a dummy treatment). Another trial of calves aged from 24 to 48 hours also compared Halocur with placebo and showed that medicine was effective at preventing diarrhoea due to C. parvum. Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.
Halocur should not be given to calves with diarrhoea present for more than 24 hours, or to weak animals.
For the full list of side effects and restrictions of Halocur, see the package leaflet.
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.
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.
The withdrawal period for meat from newborn calves treated with Halocur is 13 days.
The European Medicines Agency decided that Halocur’s benefits are greater than its risks and it can be authorised for use in the EU.
Halocur received a marketing authorisation valid throughout the EU on 29 October 1999.
Product information
Latest procedure affecting product information:
IB/0016
16/08/2019
Product details
- Name of medicine
- Halocur
- Active substance
- halofuginone
- International non-proprietary name (INN) or common name
- halofuginone
- Species
- Calves, newborn
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP51AX08
Pharmacotherapeutic group
AntiprotozoalsTherapeutic 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.
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