Each ml contains:

For full list of excipients, see 6.1.

Pour-on solution.

Pale yellow oily solution.

Cattle

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

− Cydectin 0.5% w/v Pour-On for Cattle has a persistent effect in preventing against reinfection by:

• Ostertagia ostertagi for 5 weeks

• Dictyocaulus viviparus for 6 weeks.

Not to be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

See Section "Withdrawal period(s)".

None.

For topical application only.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the veterinary medicinal 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.

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

− Avoid direct contact with skin and eyes.

− Wash hands after use.

− Protective clothes and gloves are recommended when using the veterinary medicinal product.

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

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

∙ Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of cattle with the veterinary medicinal product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 weeks and may decrease dung fly abundance during that period. It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no-long term effects. Nevertheless, in case of repeated treatments with moxidectin (as with veterinary medicinal products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.

∙ Moxidectin is inherently toxic to aquatic organisms including fish. The veterinary medicinal product should be used only according to the label instructions. Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.

Not applicable.

Cattle

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Application site reaction Neurological signs (such as ataxia and trembling) Lethargy

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

The safety of moxidectin was established during pregnancy, lactation and in breeding bulls.

See Section "Withdrawal period(s)".

None known.

Pour on use.

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.

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

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

Meat and offal: 14 days.

Milk: 6 days (144 hours).

Pharmacotherapeutic group: endectocide (milbemycin family)

ATCvet code: QP54AB02

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.

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%.

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance. In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:

EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.

NOEC: the concentration in the study at which no effects are observed.

This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life. To mitigate this risk, all precautions for use and disposal must be adhered to.

Aromatic Solvent

Myristal Propoxylate Propionic Ester

Polybutene Polymer

Propylene Glycol

Butylated hydroxyanisole (E320)

Tertiary Butylhydroquinone

Citric Acid Monohydrate (E330)

Fractionated coconut oil

Not to be mixed with other veterinary medicinal products before administration.

Shelf life of the veterinary medicinal product as packaged for sale: 24 months.

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

Keep the container in the outer carton to protect from light.

Do not store above 25°C.

If accidentally frozen, shake vigorously before use.

500, 1000, 2500 and 5000 ml fluorinated high-density polyethylene containers.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The veterinary medicinal product should not enter water courses as moxidectin may be dangerous for fish and other aquatic organisms.

Zoetis UK Limited

1st Floor, Birchwood Building

Springfield Drive

Leatherhead

Surrey

KT22 7LP

Vm 42058/5131

10 January 1997

February 2024

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.