Cevazuril 50 mg/ml, Oral Suspension for Piglets and Calves

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Toltrazuril

Tillgänglig från:

Ceva Animal Health Ltd

ATC-kod:

QP51AJ01

INN (International namn):

Toltrazuril

Läkemedelsform:

Oral suspension

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Cattle, Pigs

Terapiområde:

Antiprotozoal anticoccidial

Bemyndigande status:

Authorized

Tillstånd datum:

2010-06-25

Produktens egenskaper

Revised: September 2022
AN: 01487/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevazuril 50 mg/ml, oral suspension for Piglets and Calves.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Toltrazuril..................... 50.0 mg
EXCIPIENTS:
Sodium benzoate (E211) 2.1 mg
Sodium propionate (E281) 2.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
White homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (Piglet 3 - 5 days old).
Cattle (calves on dairy farms).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Piglets:
For the prevention of clinical signs of coccidiosis in neonatal
piglets on farms with a
confirmed history of coccidiosis caused by _Isospora suis_.
Calves:
For the prevention of clinical signs of coccidiosis and reduction of
coccidia shedding
in housed calves replacing cows producing milk for human consumption
(dairy cows)
on farms with a confirmed history of coccidiosis, caused by _Eimeria
bovis_ or _Eimeria _
_zuernii_.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
Revised: September 2022
AN: 01487/2022
Page 2 of 6
Cattle (for environmental reasons):
Do not use in calves weighing more than 80 kg bodyweight.
Do not use in fattening units such as veal or beef calves.
For more details, see section 4.5, other precautions and section 5,
environmental
properties.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and repeated use of
antiprotozoals from the
same class may lead to the development of resistance.
It is recommended to treat all piglets in a litter and all calves in a
pen.
Hygienic measures may reduce the risk of porcine and bovine
coccidiosis. It is
therefore, recommended to improve concomitantly the hygienic
conditions in the
concerned facility, particularly dryness and cleanliness.
To alter the course of an established clinical coccidia