Halofusol 0.5 mg/ml oral solution for calves

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Halofuginone

Available from:

Laboratorios Karizoo S.A.

ATC code:

QP51AX08

INN (International Name):

Halofuginone

Dosage:

0.5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

halofuginone

Authorization status:

Authorised

Authorization date:

2020-12-18

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2020
CRN009Q9C
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Halofusol 0.5 mg/ml oral solution for calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Halofuginone
​0.50 mg
Equivalent to 0.6086 mg of
halofuginone lactate​
​
​
​
​
EXCIPIENTS:
​
​
Benzoic acid (E 210)
​1.00 mg
​
Tartrazine (E 102)
​0.03 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (newborn 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 life.

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.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
18 December 2020
CRN009Q9C
Page 2 of 5
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 the metering pump included 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