CHANIL 34 MG/ML ORAL SUSPENSION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-09-2016
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Active ingredient:
OXYCLOZANIDE BP (VET)
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QP52AG06
INN (International Name):
OXYCLOZANIDE BP (VET)
Dosage:
34 Mg/Ml
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Oxyclozanide
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2016-02-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Chanil 34 mg/ml oral suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxyclozanide
34.0 mg
EXCIPIENT:
Methyl Parahydroxybenzoate (E218) 2.0 mg
Propyl Parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
A smooth uniform off-white to yellow suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
INDICATIONS:
Treatment of chronic fascioliasis caused by the adult stage of _Fasciola hepatica_, sensitive to oxyclozanide.
Elimination of gravid tapeworm segments (_Moniezia _spp).
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/09/2016_
_CRN 7024383_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
At normal dose levels, oxyclozanide is not active against immature flukes present in liver tissue.
Milking cattle, particularly high yielders, may show a reduction in yield, occasionally of 5 % or more, for about 48
hours after handling. The effect of this small loss may be minimised by spreading herd dosing over a period of about
one week.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 09/09/2016_
_CRN 7024383_
_page number: 2_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When a dosing gun is used to administer the product, care must be taken to avoid damage to the pharyngeal region.
Adverse effects
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