Coxx-Kure 50 mg/ml oral suspension for piglets and calves

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

LAPROVET

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2015-01-05

Summary of Product characteristics

Health Products Regulatory Authority
15 October 2021
CRN0099GF
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Coxx-Kure 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
For environmental reasons:
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
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 coccidial infection in
individual animals already s