PACKAGE LEAFLET:

HALOCUR 0.5 mg/ml oral solution for calves

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35

   5831 AN Boxmeer The Netherlands

   
   

   Manufacturer responsible for batch release: Intervet Productions S.A.

   Rue de Lyons 27460 Igoville France

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   HALOCUR 0.5 mg/ml oral solution for calves

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

   
   

   The veterinary medicinal product is a canary yellow oral solution. HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt).

   
   

4. INDICATION(S)

   
   

   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

   
   

5. 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.

   
   

6. ADVERSE REACTIONS

   An increase in the level of diarrhoea has been observed in treated animals in very rare cases. The frequency of adverse reactions is defined using the following convention:

   • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

   • common (more than 1 but less than 10 animals in 100 animals treated )

   • uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

   • rare (more than 1 but less than 10 animals in 10,000 animals treated)

   • very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   New born calves.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   For oral use in calves after feeding.

   
   

   The dosage is: 100 µg of halofuginone base / kg body weight (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 BW).

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   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.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 13 days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children.

    
    

    This medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 6 months.

    
    

12. SPECIAL WARNING(S)

    
    

    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:

    
    

    Repetitive contact with the product may lead to skin allergies. Avoid skin, eye or mucosal contact with the product. Wear protective gloves while handling the product.

    In case of skin and eye contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice.

    Wash hands after use.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    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.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Medicines should not be disposed of via wastewater.

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    HALOCUR should not enter water courses as this may be dangerous for fish and other aquatic organisms.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    DD/MM/YYYY

    ).

    
    

15. OTHER INFORMATION

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.

Not all pack sizes may be marketed.