Open menu Close menu Open Search Close search

AMERICAN DRUGS | ANATOMY | HEALTH TOPICS | HIV/AIDS GLOSSARY | DISEASES | HEALTH ARTICLES | GENOME | OCCUPATIONS

Halocur

Spanish Simplified Chinese French German Russian Hindi Arabic Portuguese















Summary for the public


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 7 consecutive days, in calves aged from 4 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.

Authorisation details
Name: Halocur
EMEA Product number: EMEA/V/C/000040
Active substance: halofuginone
INN or common name: Halofuginone
Species: Calves, newborn
ATCvet Code: QP51AX08
Marketing Authorisation Holder: Intervet International BV
Revision: 7
Date of issue of Market Authorisation valid throughout the European Union: 29/10/1999
Contact address:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



  • Drugs Alphabetically





    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HALOCUR 0.5 mg/ml oral solution for calves
    2.
    Qualitative and quantitative composition
    Active substance
    Halofuginone base
    0.50 mg/ml
    Excipients
    Benzoic acid (E 210) 1.00 mg/ml
    Tartrazine (E 102) 0.03 mg/ml
    For a full list of excipients, see section 6.1
    3.
    Pharmaceutical form
    Oral solution.
    4.
    Clinical particulars
    4.1 Target species
    New born calves.
    4.2 Indications for use, specifying the target species
    In new born 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 oocysts excretion has been demonstrated.
    4.3 Contraindications
    Do not use on an empty stomach.
    Do not use in case of diarrhoea established for more than 24 hours and in weak animals.
    4.4 Special warnings
    None.
    2/12
    (as lactate salt)
    4.5 Special precautions for use
    Special precautions for use in animals
    Administer after colostrum feeding, or after milk or milk replacer feeding only, using either a syringe
    or any appropriate device for oral administration. Do not use on an empty stomach. For treatment of
    anorexic calves, the product should be administered in half a litre of an electrolyte solution. The
    animals should receive enough colostrum according to good breeding practice.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    To the user:
    •
    Repetitive contact with the product may lead to skin allergies.
    •
    Avoid skin and eye contact with the product. In case of skin and eye contact wash the exposed
    area thoroughly with clean water. If an eye irritation persists, seek medical advice.
    •
    Wear protective gloves while handling the product.
    •
    Wash hands after use.
    4.6 Adverse reactions (frequency and seriousness)
    In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
    4.7 Use during pregnancy, lactation or lay
    Not applicable.
    4.8 Interaction with other medicinal products and other forms of interaction
    None known.
    4.9 Amounts to be administered and administration route
    For oral use in calves after feeding
    The dosage is: 100 µg of halofuginone base / kg bw / once a day for 7 consecutive days, i.e. 2 ml of
    HALOCUR / 10 kg bw / once a day for 7 consecutive days.
    However, in order to make the HALOCUR treatment easier, a simplified dosage scheme is proposed:
    •
    35 kg < calves ≤ 45 kg: 8 ml of HALOCUR once a day during 7 consecutive days
    •
    45 kg < calves < 60 kg: 12 ml of HALOCUR once a day during 7 consecutive days
    For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg).
    To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration
    is necessary.
    The consecutive treatment should be done at the same time each day.
    Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated
    as long as the risk for diarrhoea due to C. parvum persists.
    3/12
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the
    recommended dosage strictly. Symptoms of toxicity include diarrhoea, visible blood in faeces, decline
    in milk consumption, dehydration, apathy and prostration. Should clinical signs of overdosing occur
    the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
    Rehydration may be necessary.
    4.11 Withdrawalperiod
    Meat and offal: 13 days.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Quinazolinone derivate, ATCvet code: QP51AX08
    5.1
    Pharmacodynamic properties
    The active substance, Halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group
    (nitrogenous polyheterocycles). Halofuginone lactate (RU 38788) is a salt whose antiprotozoal
    properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro
    conditions and in artificial and natural infections. The compound has a cryptosporidiostatic effect on
    Cryptosporidium parvum . It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
    The concentrations to inhibit 50 % and 90 % of the parasites, in an in vitro test system, are IC 50 < 0.1
    µg/ml and IC 90 of 4.5 µg/ml respectively.
    5.2 Pharmacokinetic particulars
    The bioavailability of the drug in the calf, following single oral administration, is about 80 %. The
    time necessary to obtain the maximum concentration T max is 11 hours. The maximum concentration in
    plasma C max is 4 ng/ml. The apparent volume of distribution is 10 l/kg. The plasmatic concentrations
    of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after
    single oral treatment. Unchanged halofuginone is the major component in the tissues. Highest values
    have been found in the liver and the kidney. The product is mainly excreted in the urine. The terminal
    elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral
    administration.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Benzoic acid (E 210)
    Tartrazine (E 102)
    6.2 Incompatibilities
    None known.
    6.3 Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
    Shelf-life after first opening the container: 6 months.
    4/12
    6.4 Special precautions for storage
    This medicinal product does not require any special storage conditions.
    6.5 Nature and composition of immediate packaging
    High-density polyethylene portable bottle of 500 ml containing 490 ml of the oral solution.
    High-density polyethylene portable bottle of 1000 ml containing 980 ml of the oral solution.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    HALOCUR should not enter watercourses, as this may be dangerous for fish and other aquatic
    organisms. Any unused veterinary medicinal product or waste materials derived from such veterinary
    medicinal products should be disposed of in accordance with the local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/99/013/001-002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    23.11.2009
    10.
    DATE OF REVISION OF THE TEXT
    23.11.2009
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5/12
    ANNEX II
    A.
    MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    6/12
    A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
    Name and address of the manufacturer(s) responsible for batch release
    Intervet Productions SA
    Rue de Lyons
    F-27460 Igoville
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    In accordance with Council Regulation (EEC) No 2377/90, as amended and in accordance with Article
    34.4b of Regulation (EEC) No 726/2004 of 31 March 2004.Halofuginone is included in Annex I of
    Council Regulation (EEC) No 2377/90 in accordance with the following table:
    Pharmacologically active
    substance
    Marker residue
    Animal species MRLs (*)
    Target tissues
    Halofuginone
    Halofuginone
    Bovine
    30 µg/kg
    30 µg/kg
    10 µg/kg
    25 µg/kg
    Liver
    Kidney
    Muscle
    Fat
    7/12
     
    ANNEX III
    LABELLING
    8/12
    LABELLING
    9/12
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    500 ml bottle/1000 ml bottle
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    HALOCUR 0.5 mg/ml oral solution for calves
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Halofuginone base (as lactate salt) 0.50 mg/ml
    Benzoic acid (E 210) 1.00 mg/ml
    Tartrazine (E 102) 0.03 mg/ml
    3.
    PHARMACEUTICAL FORM
    Oral solution
    4.
    PACKAGE SIZE
    500 ml bottle containing 490 ml of oral solution / 1000 ml bottle containing 980 ml of oral solution
    5.
    TARGET SPECIES
    New born calves
    6.
    INDICATION(S)
    In new born 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 oocysts excretion has been demonstrated.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For oral use in calves after feeding:
    •
    35 kg < calves ≤ 45 kg: 8 ml of HALOCUR once a day for 7 consecutive days
    •
    45 kg < calves < 60 kg: 12 ml of HALOCUR once a day for 7 consecutive days
    10/12
     
    For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg).
    To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration
    is necessary.
    The consecutive treatment should be done at the same time each day.
    Once the first calf has been treated, all the forthcoming new born calves must be systematically treated
    as long as the risk for diarrhoea due to C. parvum persists.
    8.
    WITHDRAWAL PERIOD
    Meat and offal: 13 days.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Do not use on an empty stomach.
    Do not use in case of diarrhoea established for more than 24 hours and in weak animals.
    For treatment of anorexic calves, the product should be administered in half of a litre of an electrolyte
    solution. The animals should receive enough colostrum according to good breeding practice.
    Overdose:
    As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the
    recommended dosage strictly. Symptoms of toxicity include diarrhoea, visible blood in faeces, decline
    in milk consumption, dehydration, apathy and prostration. Should clinical signs of overdosing occur
    the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
    Rehydration may be necessary.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals:
    •
    Repetitive contact with the product may lead to skin allergies.
    •
    Avoid skin and eye contact with the product. In case of skin and eye contact wash the exposed
    area thoroughly with clean water. If an eye irritation persists, seek medical advice.
    •
    Wear protective gloves while handling the product.
    •
    Wash hands after use.
    10. EXPIRY DATE
    EXP: month/year
    Once broached, use within 6 months.
    11. SPECIAL STORAGE CONDITIONS
    This medicinal product does not require any special storage conditions.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    HALOCUR should not enter watercourses, as this may be dangerous for fish and other aquatic
    organisms. Any unused veterinary medicinal product or waste materials derived from such veterinary
    medicinal products should be disposed of in accordance with the local requirements.
    11/12
     
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only. To be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B.V.
    Wim de Körverstraat 35
    NL-5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/99/013/001-002
    17. MANUFACTURER’S BATCH NUMBER
    <Batch> <Lot> <BN> number
    12/12
     


    Source: European Medicines Agency


    - Please bookmark this page (add it to your favorites).
    - If you wish to link to this page, you can do so by referring to the URL address below this line.

    https://theodora.com/drugs/eu/halocur_veterinary.html

    Copyright © 1995-2021 ITA all rights reserved.