SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cydectin* 0.5% w/v Pour-On for Cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Moxidectin 5.00 mg

Excipients:

Butylated hydroxyanisole (E320) 0.10 mg

Tert-butyl hydroquinone (E319) 0.03 mg

Butylated hydroxytoluene (E321) < 0.03 mg

For full list of excipients, see 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

• 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.

4.3 Contraindications

Not to be used in other species as severe adverse reactions, including fatalities in dogs, may occur. See Section 4.11.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use Special precautions for use in animals

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.

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

The veterinary product may cause skin and eye irritation. Avoid direct contact with skin and eyes. Do not smoke, drink or eat while handling the product. Wash hands after use. Personal protective equipment consisting of gloves, protective work clothing and safety glasses should be worn when handling the veterinary medicinal product. If spillage onto clothing occurs, remove any contaminated clothing immediately and wash exposed skin with soap and water.

In case of accidental splash onto the eye or skin, wash with plenty of clean, running water immediately. If irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment

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 nontarget 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.

Other precautions Not applicable.

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation or lay

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

See Section 4.11.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amount(s) to be administered and administration route

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.

To ensure a correct dosage, 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 body weight and dosed accordingly, in order to avoid under- or overdosing. Shake before use.

Directions for using the Squeeze-Pour System (500 ml and 1 litre bottles only):

Step 1: Remove screw cap from dispensing chamber only. Remove foil seal.

Step 2: Gently squeeze the bottle to fill the measuring chamber with the required amount of liquid.

Step 3: Pour the measured volume of fluid from the chamber onto the animal as directed.

Repeat steps 2 and 3 for subsequent animals

Step 4: Reapply the screw cap to the dispensing chamber after use.

Directions for using a pour-on applicator (2.5 and 5 litre backpack):

Connect the pour-on applicator to the backpack as follows:

Attach the open end of the draw-off tubing to the cap with the stem.

Replace shipping cap with the cap that has the draw-off tubing. Tighten the draw-off cap.

Gently prime the pour-on applicator, checking for leaks.

Follow manufacturer’s directions for correct use and care of equipment.

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

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.

4.11 Withdrawal period(s)

Meat and offal: 14 days.

Milk: 6 days (144 hours).

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: endectocide (milbemycin family)

ATCvet 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%.

5.3 Environmental properties

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:

Organism		EC50	NOEC
Algae	S. capricornutum	>86.9 μg/l	86.9 μg/l
Crustaceans (Water fleas)	Daphnia magna (acute)	0.0302 μg/l	0.011 μg/l
	Daphnia magna (reproduction)	0.0031 μg/l	0.010 μg/l
Fish	O. mykiss	0.160 μg/l	Not determined
	L. macrochirus	0.620 μg/l	0.52 μg/l
	P. promelas (early life stages)	Not applicable	0.0032 μg/l
	Cyprinus carpio	0.11 μg/l	Not determined

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Solvent naphta light aromatic

Polyoxypropylene (PPG-2) myristyl ether propionate

Polybutene

Mono- and diglycerides of fatty acids

Propylene glycol

Corn oil

Butylated hydroxyanisole (E320)

Tert-butyl hydroquinone (E319)

Citric acid monohydrate

Butylated hydroxytoluene (E321)

Medium-chain triglycerides

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

6.4 Special precautions for storage

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

Do not store above 25°C.

If accidentally frozen, shake vigorously before use.

6.5 Nature and composition of immediate packaging

500 ml and 1 l fluorinated high-density polyethylene containers with PP screw cap closure and a polyethylene seal.

2.5 l fluorinated high-density polyethylene backpack containers with PP screw cap closure and two PP spouted caps with a nitrile joint.

5 l fluorinated high-density polyethylene backpack containers with PP screw cap closure and a PP spouted cap with a nitrile joint.

Pack sizes:

Container of 500 ml

Container of 1 l

Container of 2.5 l Container of 5 l

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

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 aquaticorganisms.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

1st Floor, Birchwood Building

Springfield Drive

Leatherhead

Surrey

KT22 7LP

8. MARKETING AUTHORISATION NUMBER

Vm 42058/5131

9. DATE OF FIRST AUTHORISATION

10 January 1997

10. DATE OF REVISION OF THE TEXT

August 2026

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

Approved 26 August 2026