Chanil 34 mg/ml oral suspension for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxyclozanide

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AG06

INN (International Name):

Oxyclozanide

Dosage:

34 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

oxyclozanide

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2016-02-19

Summary of Product characteristics

Health Products Regulatory Authority
05 March 2021
CRN009X66
Page 1 of 4
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
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 known cases of hypersensitivity to the active substance
or to any of the excipients.
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.
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and could
ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class,
over an extended period of time
- Underdosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration
of the dosing device (if any).
- Suspected clinical cases of resistance to anthelmintics should be
further investigated using appropriate tests (e.g. Faecal Egg
Count Reduction Test). Where the results of the test(s) strongly
suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different