Target Species
Cattle (newborn calf).
Indications for use
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.
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.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or risk of infection based on its epidemiological features, for each herd.
Special precautions for use
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.
Operator warnings
Repetitive contact with the product may lead to skin allergies.
Avoid skin, eye and mucosal contact with the veterinary medicinal product.
People with known hypersensitivity to halofuginone should administer the veterinary medicinal product with caution.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
In case of accidental spillage onto skin or eye contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Adverse Reactions
Cattle (newborn calf):
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Diarrhoea1 |
1 an increase in the level of diarrhoea has been observed.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Not applicable.
Interactions
None known.
Amounts to be administered and administration route
Oral use.
To be administered after feeding.
The dosage is: 100 mcg of halofuginone base / kg body weight (BW) / once a day for 7 consecutive days, i.e. 2 ml of the veterinary medicinal product / 10 kg BW / once a day for 7 consecutive days.
However, in order to make the treatment easier, a simplified dosage scheme is proposed:
•35 kg < calves ≤ 45 kg: 8 ml of the veterinary medicinal product once a day during 7 consecutive days
•45 kg < calves < 60 kg: 12 ml of the veterinary medicinal product once a day during 7 consecutive days
For smaller or higher weights, a precise calculation should be performed (2 ml/10 kg BW).
Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The use of suitably calibrated measuring equipment is recommended.
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 Cryptosporidium parvum persists.
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.
Withdrawal periods
Meat and offal: 13 days.