Toltranil 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:

Authorized

Authorization date:

2011-09-27

Summary of Product characteristics

Revised: April 2020
AN: 01882/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltranil 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 _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:
Revised: April 2020
AN: 01882/2019
Page 2 of 6
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 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 resistance.
It is recommended to treat all calves or lambs in a pen. Hygienic
measures may reduce
the risk of coccidiosis. It is therefore, recommended to improve
concomitantl