BOVICOX 50 MG/ML ORAL SUSPENSION FOR CATTLE AND SHEEP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TOLTRAZURIL

Available from:

J. & M. Veterinary Services Ltd

ATC code:

QP51AJ01

INN (International Name):

TOLTRAZURIL

Dosage:

50 Mg/Ml

Pharmaceutical form:

Oral Suspension

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine, Ovine

Therapeutic area:

Toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2013-09-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovicox 50 mg/ml oral suspension for cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral suspension.
Thick white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves on dairy farms).
Sheep (lambs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
For the prevention of clinical signs of coccidiosis and reduction of oocyst 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_.
Sheep:
For the prevention of clinical signs of coccidiosis and reduction of oocyst shedding in lambs on farms with a confirmed
history of coccidiosis caused by _Eimeria crandallis _and _Eimeria ovinoidalis_.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance or any of the excipients.
Cattle:
For environmental reasons:
Do not use in calves weighing more than 80 kg body weight.
Do not use in fattening units such as veal or beef calves.
For more details see sections 4.5, other precautions and section 5, environmental properties.
1 ml of oral suspension contains:
ACTIVE SUBSTANCE:
Toltrazuril
50 mg
EXCIPIENTS:
Sodium benzoate (E211)
2.1 mg
Sodium propionate (E281)
2.1 mg
For the full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/02/2015_
_CRN 7019707_
_page number: 1_
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 t