TRATOL 50 MG/ML ORAL SUSPENSION FOR PIGS, CATTLE AND SHEEP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-06-2016
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Active ingredient:
TOLTRAZURIL
Available from:
Krka, d.d., Novo mesto
ATC code:
QP51AJ01
INN (International Name):
TOLTRAZURIL
Dosage:
50 Mg/Ml
Pharmaceutical form:
Oral Suspension
Prescription type:
POM
Therapeutic group:
Bovine, Ovine, Porcine
Therapeutic area:
Toltrazuril
Therapeutic indications:
Coccidiostats
Authorization status:
Authorised
Authorization date:
2011-05-13
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tratol 50 mg/ml oral suspension for pigs, cattle and sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 _Isospora 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 known hypersensitivity to the active substance or any of the excipients.
Cattle (for environmental reasons):
Do not use in calves weighing more than 80 kg body weight.
Do not use in veal or beef calves.
For more details see sections 4.5, other precautions and section 5, environmental properties.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 10/06/2016_
_CRN 7022329_
_page number: 1_
4.4 SPECIAL WARNING
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