Baycox Bovis 50mg/ml oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Bayer Limited

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

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2006-01-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Bovis 50mg/ml oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral suspension.
White or yellowish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves on dairy farms).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 calves weighing more than 80 kg bodyweight.
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.
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 calves in a pen
Hygienic measures may reduce the risk of bovine coccidiosis. It is
therefore, recommended to improve concomitantly
the hygienic conditions in the concerned facility, particularly
dryness and cleanliness.
To obtain maximum benefit, animals should be treated before the
expected onset of clinical signs, i.e. in the prepatent
period.
To alter the course of an established clinical coccidial infection, in
individual animals already showing signs of
diarrhoea, additional supportive therapy may be required.
1 ml contains:
ACTIVE SUBSTANCE:
Toltrazuril
50.0 mg
EXCIPIENT(S):
Sodium benzoate (E211)
2.1
mg
Sodium propionate (E281)
2.1
mg
For a full list of excipients, see section 6.1.
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