Stenorol Crypto 0.5 mg/ml Oral Solution for Calves

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Halofuginone

Available from:

Huvepharma N.V.

ATC code:

QP51AX08

INN (International Name):

Halofuginone

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antiprotozoal

Authorization status:

Authorized

Authorization date:

2020-07-23

Summary of Product characteristics

Revised: June 2021
AN: 01612/2020 and 01645/2020
Page 1 of 5
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
CONTRA-INDICATIONS
Do not use on an empty stomach.
Do not use in case of diarrhea established for more than 24 hours and
in weak
animals.
Revised: June 2021
AN: 01612/2020 and 01645/2020
Page 2 of 5
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None.
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 cause allergic reactions
in some
people. People with known