Zanil Fluke Drench 34 mg/ml Oral Suspension 5L.
Cattle and sheep.
Indications for use
For the treatment and control of chronic fascioliasis in cattle and sheep.
It removes practically all flukes (Fasciola spp.) present in the bile ducts of the liver.
Do not use in cases of hypersensitivity to the active substance.
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.
Special precautions for use
Special precautions for use in animals
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 should be used.
To date no resistance to oxyclozanide has been reported. Use of the product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Care should be taken when administering by dosing gun.
Due regard must be given to the physical condition of the animals undergoing treatment, particularly those in advanced pregnancy and / or under stress from adverse weather conditions, poor nutrition, penning, handling etc.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke when using this product.
Wash splashes from eyes and skin immediately.
Take off any contaminated clothing immediately.
User should wear chemical resistant gloves during administration of the product.
Wash hands and exposed skin before meals and after work.
Adverse reactions (frequency and seriousness)
At normal oxyclozanide dose levels, cattle may show slight softening of the faeces with the occasional animal showing increased frequency of defecation and transient inappetence. The effects of oxyclozanide overdosage are dullness and some loosening of faeces in sheep and possible diarrhoea, inappetance and loss of weight in cattle. These effects are occasionally enhanced in animals with severe liver damage and/or dehydration at the time of dosing.
Use during pregnancy, lactation or lay
The product may be given to young, pregnant and lactating animals.
Amounts to be administered and administration route
The product can be given to young, pregnant and lactating animals and those in debilitated condition (in the absence of inter current disease).
Give as an oral drench. Shake the product well before use.
The body weight of animals should be assessed as accurately as possible before calculating the dosage. The accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.
Dose according to body weight at the rate of 10 mg oxyclozanide per kg body weight for cattle and 15 mg oxyclozanide per kg body weight for sheep as follows:
The effects of oxyclozanide overdosage are dullness and some loosening of faeces in sheep and possible diarrhoea, inappetence and loss of weight in cattle. These effects are occasionally enhanced in animals with severe liver damage and/or dehydration at the time of dosing.
Meat and offal: 13 days.
Milk: 108 hours (4.5 days).
Meat and offal: 14 days.
Milk: 7 days
Pharmacotherapeutic group: Anthelmintics, Oxyclozanide
ATCvet code: QP52AG06
Oxyclozanide is an anthelmintic of the salicylanilide group. It is effective against Fasciola species, acting as an uncoupler of oxidative phosphorylation. It may act at more than one site to decrease levels of ATP leading to metabolic malfunction and death of the parasite.
Oxyclozanide is slowly absorbed after oral administration with peak plasma levels 24 hours after dosing. Excretion is predominantly faecal, biliary excretion being the most important route of elimination (cattle studies only).
Sodium metabisulphite (antioxidant) E223, Methyl hydroxybenzoate (preservative) E218, Propyl hydroxybenzoate (preservative), Sodium laurilsulphate, Aluminium magnesium silicate, Carmellose sodium, Sodium citrate and Purified water.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25 °C. Protect from light. Do not freeze.
An off-white, smooth uniform suspension in the following packs:
- 5 and 10 litre high density polyethylene flexipacks with polypropylene or urea formaldehyde screw caps with wads of PVDC-faced paper or a pulpboard liner.
- 1, 2.5, 5 litre high density polyethylene back packs with polypropylene screwcaps.
Not all pack sizes may be marketed.
Do not contaminate ponds, waterways or ditches with the product or used container.
Harmful to aquatic life.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.