Tratol 50 mg/ml oral suspension for pigs, cattle and sheep

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

即購入

製品の特徴 製品の特徴 (SPC)
12-06-2017
公開評価報告書 公開評価報告書 (PAR)
19-12-2019

有効成分:

Toltrazuril

から入手可能:

Krka, d.d., Novo mesto

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, Sheep

治療領域:

toltrazuril

適応症:

Coccidiostats

認証ステータス:

Authorised

承認日:

2011-05-13

製品の特徴

                                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.
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