Halofusol 0.5 mg/ml oral solution for calves

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Halofuginone

Dostępny od:

Laboratorios Karizoo S.A.

Kod ATC:

QP51AX08

INN (International Nazwa):

Halofuginone

Dawkowanie:

0.5 milligram(s)/millilitre

Forma farmaceutyczna:

Oral solution

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

halofuginone

Status autoryzacji:

Authorised

Data autoryzacji:

2020-12-18

Charakterystyka produktu

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