SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zermex 0.5% w/v Pour-On Solution for Cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Moxidectin 0.5 % w/v

Excipient(s):

Butylated hydroxyanisole (E320) 0.010 % w/v

Tert butyl hydroquinone 0.003 % w/v

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Pour-on solution

Pale yellow oily solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle

4.2 Indications for use, specifying the target species

Infections of cattle with parasites sensitive to moxidectin.

For the treatment of infections caused by:

- Adult and larval gastro-intestinal nematodes:

Haemonchus placei

Ostertagia ostertagi (including inhibited larvae)

Trichostrongylus axei

Nematodirus helvetianus

Cooperia oncophora

Cooperia punctata (adults)

Oesophagostomum radiatum (adults)

Bunostomum phlebotomum (adults)

- Adult respiratory tract nematode

Dictyocaulus viviparus

- Warbles (migrating larvae)

Hypoderma bovis

Hypoderma lineatum

- Lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Bovicola bovis (Damalinia bovis)

- Mange Mites

Sarcoptes scabiei

Psoroptes ovis

Chorioptes bovis

- Horn Flies

Haematobia irritans

In cattle it has a persistent effect in preventing against reinfection by:

Ostertagia ostertagi for 5 weeks

Dictyocaulus viviparusfor 6 weeks.

4.3 Contraindications

None

4.4 Special warnings

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:

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.

To date, no resistance to moxidectin in cattle parasites has been reported. The use of this product should be based on local (regional, farm) epidemiological information about susceptibility of the nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use

i. Special precautions for use in animals

All animals in a group should be treated.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of fly activity and before the larvae reach their resting sites: consult the veterinarian to know the correct treatment period.

For external use only.

For topical application only.

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid direct contact with skin and eyes.

If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.

Seek medical advice if irritation persists.

Wear protective clothes and impermeable gloves when applying the product.

Do not eat, drink or smoke whilst handling the product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Moxidectin has been shown to be safe for use in pregnant and lactating animals and breeding bulls.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

500 µg moxidectin/kg body weight (1 ml for 10 kg) as a single topical application.

To be administered along the midline of the back of the animal from the withers to the tailhead.

Apply to clean healthy skin.

To ensure administration of a correct dose, bodyweight 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 over dosing.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No symptoms of overdosage have been observed with the product given at ten times the recommended dose.

They are manifested as transient salivation, depression, drowsiness and ataxia. There is no specific antidote.

4.11 Withdrawal period(s)

Meat and offal: 14 days.

Milk: 6 days (144 hours).

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code: QP54AB02

5.1 Pharmacodynamic properties

Moxidectin is a parasiticide active against a wide range of important internal and external parasites. It is a second generation macrocyclic lactone of the milbemycin family. Its principal mode of action is interference with the GABA (gamma amino butyric acid) receptors involved with neuromuscular transmission.

Moxidectin stimulates the release of GABA and increases its binding to the postsynaptic receptors. The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This results in flaccid paralysis and eventual death of parasites exposed to the drug.

5.2 Pharmacokinetic particulars

Following pour-on application, the drug is distributed throughout the body tissues (except muscle) but due to its lipophilicity the concentrations in fat are 5-15 times those in other tissues.

Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only significant route of excretion is the faeces, where the parent compound accounts for approximately 50%.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylated hydroxyanisole (E320)

Tert butyl hydroquinone

Solvesso 100

Myristyl Propoxylate Propionic Ester

Polybutene Polymer

Propylene Glycol

Citric Acid Monohydrate

Fractionated Coconut Oil

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 6 months.

6.4. Special precautions for storage

Do not store above 25°C.

Keep the container in the outer carton.

Protect from light.

If accidentally frozen, shake vigorously before use.

6.5 Nature and composition of immediate packaging

Fluorinatedhigh-density polyethylene containers, in pack sizes of 500 ml and 1 litre squeeze-measure-pour system or 2.5 and 5 litre backpacks.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4170

9. DATE OF FIRST AUTHORISATION

Date:02-Feb-2000

10. DATE OF REVISION OF THE TEXT

Date:July 2013

Approved: 01/08/2013