Baycox Bovis 50mg/ml oral suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Toltrazuril

Tillgänglig från:

Elanco GmbH

ATC-kod:

QP51AJ01

INN (International namn):

Toltrazuril

Dos:

50 milligram(s)/millilitre

Läkemedelsform:

Oral suspension

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

toltrazuril

Bemyndigande status:

Authorised

Tillstånd datum:

2006-01-25

Produktens egenskaper

Health Products Regulatory Authority
16 October 2020
CRN009PMJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Bovis 50mg/ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
Health Products Regulatory Authority
16 October 2020
CRN009PMJ
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAK