STENOROL CRYPTO 0.5 mg/ml oral solution for calves

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Halofuginone Base (As lactate salt)

Disponible depuis:

Huvepharma NV

Code ATC:

QP51AX08

DCI (Dénomination commune internationale):

Halofuginone Base (As lactate salt)

Dosage:

0.5 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

halofuginone

Statut de autorisation:

Authorised

Date de l'autorisation:

2020-07-24

Résumé des caractéristiques du produit

Health Products Regulatory Authority
04 June 2021
CRN00C42D
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
STENOROL CRYPTO 0.5 mg/ml oral solution for calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
Active substance
​
​
Halofuginone (as lactate)
​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 liquid of intense greenish-yellow coloration.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Newborn calves)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In newborn 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 diarrhea 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 cases 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
04 June 2021
CRN00C42D
Page 2 of 4
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 an appropriate device for oral
administration. 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.
This product contains halofuginone, which can ca