Tratol 50 mg/ml Oral Suspension for Pigs, Cattle and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Toltrazuril

Available from:

Krka d.d., Novo Mesto

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Pharmaceutical form:

Oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antiprotozoal anticoccidial

Authorization status:

Expired

Authorization date:

2011-05-06

Summary of Product characteristics

Revised: May 2016
AN: 01191/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tratol 50 mg/ml oral suspension for pigs, cattle and sheep (Austria,
Belgium, France,
Germany, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom)
Tratol vet 50 mg/ml oral suspension for pigs, cattle and sheep
(Denmark, Finland)
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 _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_.
Revised: May 2016
AN: 01191/2015
Page 2 of 6
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.
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 r