Toltarox 50 mg/ml oral suspension for cattle

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Toltrazuril

Sẵn có từ:

Krka, d.d., Novo mesto

Mã ATC:

QP51AJ01

INN (Tên quốc tế):

Toltrazuril

Liều dùng:

50 milligram(s)/millilitre

Dạng dược phẩm:

Oral suspension

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Cattle

Khu trị liệu:

toltrazuril

Chỉ dẫn điều trị:

Coccidiostats

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2013-11-15

Đặc tính sản phẩm

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