Oxyfluke 34 mg/ml Oral Suspension for Cattle and Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxyclozanide

Available from:

Norbrook Laboratories (Ireland) 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 area:

oxyclozanide

Authorization status:

Authorised

Authorization date:

2017-09-26

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008TS7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxyfluke 34 mg/ml Oral Suspension for Cattle and Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of product contains:
ACTIVE SUBSTANCE:
​
Oxyclozanide
34.0 mg
EXCIPIENTS:
​
Methyl Parahydroxybenzoate
1.5 mg
Propyl Parahydroxybenzoate
0.15 mg
Sodium Metabisulphite
1.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
An off white to beige suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of chronic fascioliasis caused by the adult stage of
_Fasciola hepatica _susceptible to Oxyclozanide.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to oxyclozanide 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 occasionally show a
reduction in yield 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 a 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 investigates 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 pharmaceutical class and having a different mode
of action sho