Zanil Fluke Drench

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Oxyclozanide
Available from:
Intervet Ireland Limited
ATC code:
QP52A
INN (International Name):
Oxyclozanide
Dosage:
3.4 percent weight/volume
Pharmaceutical form:
Oral suspension
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle, Sheep
Therapeutic area:
ANTHELMINTICS
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10996/262/001
Authorization date:
1999-10-01

Read the complete document

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 1 of 6

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Zanil Fluke Drench

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance

Oxyclozanide

% 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 animals with known hypersensitivity to the active ingredient.

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.

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 2 of 6

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 byspreading 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

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 3 of 6

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 bodyweightFor 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

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 4 of 6

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.

4.11 Withdrawal period(s)

Cattle:

Meat and offal: 13 days.

Milk: 108 hours (4.5 days).

Sheep:

Meat and offal: 14 days.

Milk: 7 days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics; Oxyclozanide

ATCvet code: QP52AG06.

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 particulars

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

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 5 of 6

6.2 Major 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: 3 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 derived from the use of such products

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.

Health Products Regulatory Authority

24 November 2017

CRN000TVF

Page 6 of 6

7 MARKETING AUTHORISATION HOLDER

Intervet Ireland Limited

Magna Drive

Magna Business Park, Citywest Road

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA: 10996/262/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

October 1989

Date of latest renewal: 12

November 2010

10 DATE OF REVISION OF THE TEXT

November 2017

Similar products

Search alerts related to this product

View documents history

Share this information