Toltarox 50 mg/ml oral suspension for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Krka, d.d., Novo mesto

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:

2013-11-15

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2018
CRN000Y3T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltarox 50 mg/ml oral suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
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
​
​
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
_Eimeriazuernii_.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
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.
Health Products Regulatory Authority
18 December 2018
CRN000Y3T
Page 2 of 5
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 animal