Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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产品特点 产品特点 (SPC)
02-10-2021
公众评估报告 公众评估报告 (PAR)
02-10-2021

有效成分:

Toltrazuril

可用日期:

Elanco GmbH

ATC代码:

QP51AJ01

INN(国际名称):

Toltrazuril

剂量:

50 milligram(s)/millilitre

药物剂型:

Oral suspension

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

toltrazuril

授权状态:

Authorised

授权日期:

2016-11-25

产品特点

                                Health Products Regulatory Authority
01 October 2021
CRN00C7NZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml 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.
White or yellowish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves: dairy calves, beef suckler, bull beef), Pigs (Piglets,
3-5 days old), Sheep (lambs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle: For the prevention of clinical signs of coccidiosis and
reduction of coccidia shedding in calves on farms with a confirmed
history of coccidiosis caused by Eimeria bovis or Eimeria zuernii.
Pigs: For the prevention of clinical signs of coccidiosis in neonatal
piglets (3‑5 days old) on farms with a confirmed history of
coccidiosis caused by Cystoisospora suis.
Sheep: For the prevention of clinical signs of coccidiosis and
reduction of coccidia 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 hypersensitivity to the active substance or to
any of the excipients. For further information on use in
cattle please refer to the table in section 4.5 Special precautions
for use, Other precautions.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended to treat all animals in a pen.
Hygienic measures may reduce the risk of 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.
Health Products Regulatory Authority
01 October 2021
CRN00C7NZ
Page 2 of 5
To alter the course of a
                                
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