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Zanil fluke drench is an orally adminstered drench for the treatment and control of liver and Tapeworms in cattle and sheep. Zanil's active ingredient, Oxyclozanide, has shown to have a  high impact on rumen fluke that are present in the bile duct of the animal. Zanil is appropriate for use on both sheep and cattle all year round, although in housed animals the treatment should be re-administered 8 to 12 weeks later to control the threat of immature fluke that may have been present at the time of housing.Zanilalso boast a very short withdrawal time for dairy cattle.

Active Ingredient: Oxyclozanide

Target Species: Cattle, sheep

Treats and Controls: Liver fluke, tapeworm

Administration Method: Oral drench

Withdrawal Time: 28 days for cattle intended for meat and offal, 72 hours for cattle producing milk for human consumption. 28 days for sheep intended for meat and offal, not permitted for use on sheep producing milk for human consumption

Dosage for cattle: 15 ml per 50 kg of bodyweight

Dosage for sheep:4.5ml per 10kg Bodyweight

Always read the label and all enclosed information for Zanil Oral Suspension before administering to animals!

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zanil Fluke Drench

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance
Oxyclozanide 3.4 % w/v
Excipients
Methyl Parahydroxybenzoate E218 0.15 % w/v
Propyl Parahydroxybenzoate E216 0.015 % w/v
Sodium Metabisulphite E223
Sodium Citrate E331

3 PHARMACEUTICAL FORM
Oral suspension.
A smooth off-white suspension.

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle and Sheep.

4.2 Indications for use, specifying the target species
Indications: For the treatment and control of fascioliasis in cattle and sheep.
It removes practically all adult flukes (Fasciola spp.) present in the bile ducts of the liver. Tapeworm segments
(Moniezia) are also removed.

4.3 Contraindications
Do not use in sheep producing milk for human consumption.
Do not use in animals with known hypersensitivity to the active ingredient.
Active Substance
Oxyclozanide 3.4 % w/v
Excipients
Methyl Parahydroxybenzoate E218 0.15 % w/v
Propyl Parahydroxybenzoate E216 0.015 % w/v
Sodium Metabisulphite E223
Sodium Citrate E331

4.4 Special warnings for each target species
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 mode of action should be used.
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.

4.5 Special precautions for use
Special precaution(s) for use in animals
Care should be taken when administering by dosing gun.
Due regard must always be given to the physical condition of 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
When using, do not eat, drink or smoke.
Wash splashes immediately from eyes and skin immediately.
Take off any contaminated clothing immediately.
Wash hands and exposed skin before meals and after work.

4.6 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 defaecation and transient inappetence.
These effects are occasionally enhanced in animals suffering from severe liver damage and/or
dehydration at the time of dosing.

4.7 Use during pregnancy, lactation or lay
The product may be given to pregnant and lactating animals. However, due regard must always be given to physical
condition, particularly of any animals in advanced pregnancy, and/or under stress from adverse weather conditions,
poor nutrition, penning, handling etc.

4.8 Interaction with other medicinal products and other forms of interaction
None known.

4.9 Amounts to be administered and administration route
Give as an oral drench. Shake the product well before use.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; 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 bodyweight at the rate of 10 mg oxyclozanide per kg bodyweight (cattle) and 15 mg oxyclozanide
per kg bodyweight (sheep).
Cattle : 3 ml per 10 kg bodyweight;
For example:-
Bodyweight Dose
50 kg (approx 1 cwt) 15 ml
100 kg (approx 2 cwt) 30 ml
150 kg (approx 3 cwt) 45 ml
200 kg (approx 4 cwt) 60 ml
250 kg (approx 5 cwt) 75 ml
300 kg (approx 6 cwt) 90 ml
350 kg and over (7 cwt and over) 105 ml
Drench can be given in the feed to cattle which are fed individually. Pour the recommended dose onto their
concentrate ration. Molasses or salt may be added for shy feeders.
Sheep: 4.5 ml per 10 kg bodyweight
For example:-
Bodyweight Dose
10 kg (approx 22 lb) 4.5 ml
20 kg (approx 44 lb) 9 ml
30 kg (approx 66 lb) 13.5 ml
40 kg (approx 88 lb) 18 ml
45 kg and over (approx. 100 lb and over) 20 ml
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.

4.11Withdrawal Period(s)
Cattle:
Meat and offal: 28 days.
Milk: 72 hours.
Sheep:
Meat and offal: 28 days.
Milk: Do not use in sheep producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics; Oxyclozanide
ATCvet code: QP52AG06.
Irish Medicines Board

5.1 Pharmacodynamic properties
Oxyclozanide is a salicylanide anthelmintic. The mechanism of action is by uncoupling of oxidative phosphorylation
in liver fluke.

5.2 Pharmacokinetic properties
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).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium Laurilsulphate
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Aluminium Magnesium Silicate
Carmellose Sodium
Sodium Metabisulphite (E223)
Sodium Citrate
Purified Water

6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary
medicinal products.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4 Special precautions for storage
Store below 25°C.
Protect from light.
Do not freeze.

6.5 Nature and composition of immediate packaging
High density polyethylene bottles of 1, 2.5, 5 and 10 litre nominal volume, and high density polyethylene back-packs
of 1, 2.5 and 5 litre nominal volume.
Closure: Polypropylene or urea formaldehyde screw cap with wads of PVDC-faced paper on a pulpboard liner.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste
under national waste disposal regulations.
Do not contaminate ponds, waterways or ditches.

7 MARKETING AUTHORISATION HOLDER
Schering Plough Ltd.
Shire Park
Welwyn Garden City
Hertfordshire
AL7 1TW
England

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10277/043/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12th November 2010
 

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