SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zermex 0.1% w/v Oral Solution for Sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Moxidectin 0.100 g

Excipients:

Benzyl Alcohol 4.000 g

Butylated Hydroxy Toluene 0.250 g

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral Solution

A pale, yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Sheep

4.2 Indications for use, specifying the target species

Infections of sheep with parasites sensitive to moxidectin.

- Adult and immature (L4) gastro-intestinal nematodes:

. Haemonchus contortus (including inhibited larvae)

. Ostertagia circumcincta (including inhibited larvae)

. Ostertagia trifurcata

. Trichostrongylus axei (including inhibited larvae)

. Trichostrongylus colubriformis

. Trichostrongylus vitrinus

. Nematodirus battus

. Nematodirus spathiger

. Nematodirus filicolis(adults only)

. Strongyloides papillosus (larval stages only)

. Cooperia curticei (adults only)

. Cooperia oncophora

. Oesophagostomum columbianum

. Oesophagostomum venulosum (adults only)

. Chabertia ovina

. Trichuris ovis (adults only)

-Adult respiratory tract nematode

.Dictyocaulus filaria

- for 5 weeks by Ostertagia circumcincta and Haemonchuscontortus

- for 4 weeks by Oesophagostomumcolumbianum.

- Haemonchus contortus

- Ostertagia circumcincta

- Trichostrongylus colubriformis

- Cooperia curticei

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 anthelmintics, an anthelmintics belonging to another pharmacological class and having a different mode of action should be used.

Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2008, throughout Europe, moxidectin resistance is very rare; it has been reported in a single case involving a levamisole-, benzimidazole and ivermectin-resistant strain of Teladorsagia circumcincta. Therefore the use of moxidectin should be based on local (regional, farm) epidemiological information about susceptibility of nematodes, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to anthelmintics. These precautions are especially important when moxidectin is being used to control resistant strains.

4.5 Special precautions for use

i. Special precautions for use in animals

None known.

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

Wear protective impermeable gloves during use.

Avoid direct contact with skin and eyes.

In case of contact with skin and eyes wash affected area with clean water. Seek medical advice if irritation persists.

Do not smoke, drink or eat while handling the veterinary medicinal product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Should be given as a single oral drench of 1 ml/5 kg live bodyweight, equivalent to 200 µg moxidectin/kg live bodyweight, using any standard drenching equipment.

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.

Do not mix with other products.

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

Symptoms generally do not occur at less than 5 times the recommended dose. They are manifested as transient salivation, depression, drowsiness and ataxia 8 to 12 hours post-treatment. Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours. There is no specific antidote.

4.11 Withdrawal period(s)

Meat & offal – 14 days.

Milk – 5 days.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code: QP 54 AB 02

Moxidectin is a parasiticide active against a wide range of economically important internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family. Its principal mode of action is interfering with neuromuscular transmission of the GABA (gamma amino butyric acid)-gated or glutamate-gated chloride channels.

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 flacid paralysis and eventual death of parasites exposed to the drug.

Moxidectin is 22% absorbed following oral dosing with maximum blood concentrations being achieved 9 hours post treatment. The drug is distributed throughout the body tissues but due to its lipophilicity the target tissue is fat where concentrations are 10 to 20 times higher than those found in other tissues. The depletion half life in fat is 23-28 days.

Moxidectin undergoes limited biotransformation by hydroxylation. The only significant route of excretion is the faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl Alcohol

Butylated Hydroxytoluene

Disodium Edetate

Polysorbate 80

Propylene Glycol

Sodium Phosphate Dodecahydrate

Sodium Acid Phosphate Monohydrate

Phosphoric Acid and/or Sodium Hydroxide (For pH adjustment)

Water for injections

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: 2 years

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

6.4. Special precautions for storage

Protect from light.

Do not store above 25°C.

6.5 Nature and composition of immediate packaging

Carton containing one high-density polyethylene container of 1 litre, 2.5 litres or 5 litres, with a moulded handle and a polypropylene cap (screw fit).

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

Vm42058/4169

9. DATE OF FIRST AUTHORISATION

02-Feb-2000

10. DATE OF REVISION OF THE TEXT

July 2013

Approved: 01/08/2013