SUMMARY OF PRODUCT CHARACTERISTICS

ZERMEX 20 mg/ml LA Solution for Injection for Sheep

Each ml contains:

Active substances
Moxidectin	20 mg
Excipients Benzyl alcohol (E1519) For the full list of excipients, see section 6.1	70 mg

Solution for injection

Clear yellow liquid.

Sheep.

Sheep above 15 kg body weight.

Treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep.

Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:

- Gastro-intestinal nematodes:

. Haemonchus contortus (adults and L3)

. Ostertagia (Teladorsagia) circumcincta (adults and L3, including inhibited larvae)

. Trichostrongylus axei (adults)

. Trichostrongylus colubriformis (adults and L3)

. Nematodirus spathiger (adults)

. Cooperia curticei (macmasteri) (adults)

. Cooperia punctata (adults)

. Oesophagostomum columbianum (L3)

. Chabertia ovina (adults)

- Respiratory tract nematodes

.Dictyocaulus filaria (adults)

- Larvae of Diptera

.Oestrus ovis: L1, L2, L3

- Mange mites

. Psoroptes ovis

Trials have shown that moxidectin is effective against certain strains of

Haemonchus contortus,Teladorsagia circumcincta andTrichostrongylus spp. resistant to benzimidazoles.

The product has a persistent action and protects sheep against infection or re-infection with the following parasites for the period indicated:

Species Days

Ostertagia (Teladorsagia) circumcincta 97

Haemonchus contortus 111

Trichostrongylus colubriformis 44

Psoroptes ovis 60

Persistent efficacy periods have not been established for parasite species other than those included in the list above. Therefore, re-infection of animals on pasture contaminated by parasites other than these remains possible before the 44 day minimum persistency period demonstrated for specific species.

Do not use in sheep less than 15 kg bodyweight.

Do not inject the product by intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. See item “Special precautions for use in animals”

Do not use in cases of hypersensitivity to the active substance or to any excipients.

• 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.

I) Special precautions for use in animals

This product has been formulated specifically for subcutaneous injection in the base of the ear of sheep and must not be given by any other route of administration or to any other species. In order to prevent abscesses a strict aseptic technique is recommended.

II) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Avoid direct contact with skin and eyes.

Wash hands after use.

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

Take care to avoid self-injection. If this occurs, it is unlikely that any product related symptoms will be observed. In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician. Advice to Medical Practitioners in case of accidental self injection: Treat symptomatically.

Swelling and inflammation may be found at the injection site in some animals. The swelling generally disappears within 7 days of treatment and generally resolves without any medical treatment.

In rare cases, adverse reactions such as transitory salivation, depression, drowsiness and ataxia might occur. No particular treatment is required; these symptoms usually disappear within 24 to 48 hours. There is no specific antidote.

The frequency of adverse reactions is defined using the following convention:

• very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

• common (more than 1 but less than 10 animals in 100 animals)

• uncommon (more than 1 but less than 10 animals in 1,000 animals)

• rare (more than 1 but less than 10 animals in 10,000 animals)

• very rare (less than 1 animal in 10,000 animals, including isolated reports).

Can be used during pregnancy. However, note 4.11. Withdrawal periods.

The effects of GABA agonists are increased by moxidectin.

Dosage is 0.5 ml/10 kg bodyweight to give 1 mg moxidectin/ kg bodyweight. The 50ml vial stoppers must not be broached more than 10 times. Use automatic syringe equipment for the 200 ml and 500ml vials.

Use the following table as a guide :

		Number of doses per pack
Weight of sheep kg	Dose ml	50 ml	200 ml	500 ml
20	1.0	50	200	500
30	1.5	33	133	333
40	2.0	25	100	250
50	2.5	20	80	200
60	3.0	17	67	167
70	3.5	14	57	143
80	4.0	13	50	125
90	4.5	11	44	111
100	5.0	10	40	100

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

The injection should be administered as a single subcutaneous injection at the base of the ear using an 18 gauge, 25 hypodermic needle. With the animal's head under control, the formulation should be administered about 2 cm caudal from the anterior (rostral) edge of the pinna at the base of the ear. The skin at the base of the selected ear should be pinched and the product injected into the subcutaneous tissue. Following subcutaneous administration, the needle should be withdrawn from the skin as pressure is applied with the thumb at the point of insertion for several seconds. If leakage occurs then pressure should be applied for several additional seconds.

Diagram: Ear injection procedure

Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they should be consistent with the mode of action of moxidectin and would be manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment. The signs would usually disappear within 36 to 72 hours without treatment. There is no specific antidote.

Meat and offal: 104 days.

Milk: Not permitted for use in dairy sheep, at any stage of life.

The withdrawal period is based solely on a single injectionat the base of the ear.

Pharmacotherapeutic group : antiparasitic product, endectocide

ATCvet Code QP 54 AB 02, moxidectin

Moxidectin is an endectocide active against a wide range of internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family.

Moxidectin interacts with GABA receptors and chloride channels. 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.

The product has a persistent activity against the second instar larvae of Oestrus Ovis(L2 Larvae only) up to 80 days after treatment.
However, re-infestation with 1st instar larvae is not prevented and clinical signs arising from such re-infestation may be observed during this period.

Moxidectin is absorbed following subcutaneous injection with maximum blood concentrations (C_max24 ng/ml) being achieved 4 to 7 days post injection. Mean AUC _lastis 411 ng.d/ml. The drug is distributed throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. The depletion half life in fat is 30 - 34 days.

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

Benzyl Alcohol (E1519)

Sorbitan Oleate

Propylene glycol dicaprylocaprate

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.
Shelf life after first opening the immediate packaging: 28 days.

Do not store above 25°C. Keep the container in the outer carton in order to protect from light.

Natural high density polyethylene vials with chlorinated butyl rubber stoppers and aluminium flip off seals (50 ml) or aluminium seals (200 ml, 500ml).

Each vial is supplied in a carton.

Not all pack sizes may be marketed

EXTREMELY DANGEROUS FOR FISH AND AQUATIC ORGANISMS. 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.

Zoetis UK Limited

5^thFloor, 6 St. Andrew Street

London

EC4 3AE

Vm42058/4173

07 December 2009

S eptember 2016

Approved: 01 September 2016