Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep

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, Pigs, Sheep

Therapeutic area:

toltrazuril

Therapeutic indications:

Coccidiostats

Authorization status:

Authorised

Authorization date:

2014-12-05

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2019
CRN008SHY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep
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
Pigs (Piglet 3 - 5 days old).
Cattle (calves on dairy farms).
Sheep (lambs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
For the prevention of clinical signs of coccidiosis in neonatal
piglets (3 – 5 days) on farms with a confirmed history of
coccidiosis caused by _Cystoisospora suis_.
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 hypersensitivity to the active substance or to
any of the excipients.
Cattle (for environmental reasons):
Do not use in calves weighing more than 80 kg bodyweight.
Do not use in 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.
Health Products Regulatory Authority
29 July 2019
CRN008SHY
Page 2 of 5
It is recommended to treat all animals in a pen. Hygienic measures may
reduce the risk of coccidiosis. It is theref