TOLTAROX 50 MG/ML ORAL SUSPENSION FOR CATTLE
Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Productkenmerken
(SPC)
14-03-2015
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Werkstoffen:
TOLTRAZURIL
Beschikbaar vanaf:
Krka, d.d., Novo mesto
ATC-code:
QP51AJ01
INN (Algemene Internationale Benaming):
TOLTRAZURIL
Dosering:
50 Mg/Ml
farmaceutische vorm:
Oral Suspension
Prescription-type:
POM
Therapeutische categorie:
Bovine
Therapeutisch gebied:
Toltrazuril
therapeutische indicaties:
Coccidiostats
Autorisatie-status:
Authorised
Autorisatie datum:
2013-11-15
Productkenmerken
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltarox 50 mg/ml oral suspension for cattle
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).
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 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 solution 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
________________________________________________________________________________________________________________________
_Date Printed 27/02/2015_
_CRN 7019884_
_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 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 pre
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