Espacox 50 mg/ml oral suspension for pigs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Toltrazuril

זמין מ:

Industrial Veterinaria, S.A.

קוד ATC:

QP51AJ01

INN (שם בינלאומי):

Toltrazuril

כמות:

50 milligram(s)/millilitre

טופס פרצבטיות:

Oral suspension

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

toltrazuril

סממני תרפויטית:

Coccidiostats

מצב אישור:

Authorised

תאריך אישור:

2014-07-04

מאפייני מוצר

Health Products Regulatory Authority
10 June 2019
CRN008PQK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Espacox 50 mg/ml oral suspension for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each ml contains:
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​
​
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ACTIVE SUBSTANCE:
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​
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Toltrazuril
​50
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mg
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EXCIPIENTS:
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Sodium benzoate (E211)
​2.1
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mg
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Sodium propionate (E281)
​2.1
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mg
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Oral suspension.
White or yellowish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (Piglets, 3 - 5 days old).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_ (_Isospora suis_).
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and prolonged use of an
antiprotozoal of the same class of active substance and
underdosing due to underestimation of the live weight may result in
the development of resistances.
It is recommended to treat all piglets in a litter.
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.
To alter the course of an established clinical coccidial infection, in
individual animals already showing signs of diarrhoea,
additional supportive therapy may be required.
Health Products Regulatory Authority
10 June 2019
CRN008PQK
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the perso