Cevazuril 50 mg/ml, oral suspension for piglets and calves

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Toltrazuril

から入手可能:

Ceva Santé Animale

ATCコード:

QP51AJ01

INN（国際名）:

Toltrazuril

投薬量:

50 milligram(s)/millilitre

医薬品形態:

Oral suspension

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Cattle, Pigs

治療領域:

toltrazuril

適応症:

Coccidiostats

認証ステータス:

Authorised

承認日:

2010-06-25

製品の特徴

Health Products Regulatory Authority
23 May 2018
CRN000Y72
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevazuril 50 mg/ml, oral suspension for piglets and calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Toltrazuril.......................... 50.0 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.
White homogeneous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (Piglet 3 - 5 days old).
Cattle (calves on dairy farms).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Piglets:
For the prevention of clinical signs of coccidiosis in neonatal
piglets on farms with a
confirmed history of coccidiosis caused by _Isospora suis_.
Calves:
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 _Eimeria _
_zuernii_.
Health Products Regulatory Authority
23 May 2018
CRN000Y72
Page 2 of 6
4.3 CONTRAINDICATIONS
Do not use in cases of known 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 fattening units such as veal or beef calves.
For more details, see section 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 piglets in a litter and all calves in a
pen.
Hygienic measures may reduce the risk of porcine and bovine
coccidiosis. It is
therefore, recommended to improve concomitantly the hygienic
conditions in the
concerned facility, particularly dryness and cleanliness.
To alter