SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Rearguard

6% w/v Cutaneous solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient	% w/v
Cyromazine Other ingredients	6.00
Methyl parahydroxybenzoate	0.081
Ethyl parahydroxybenzoate	0.017
Propyl parahydroxybenzoate	0.016

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous solution

Clear, pale yellow solution

4. CLINICAL PARTICULARS

4.1 Target species

Rabbit

4.2 Indications for use, specifying the target species

For the prevention of blowfly strike (Lucilia sericata) in domestic rabbits for up to 10 weeks after dosing

4.3 Contraindications

Not to be used on rabbits less than 10 weeks of age. Do not apply to broken skin.

4.4 Special warnings for each target species

If the rabbit is continually attractive to flies, this may be due to an underlying disease e.g. diarrhoea or incontinence, or a lack of hygiene within it’s housing. In such cases further advice should be sought from your veterinary surgeon.

4.5 Special precautions for use

i. Special precautions for use in animals

Care should be taken in the treatment of old, sick or debilitated rabbits.

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

Wash hands and exposed skin after use.

Wash splashes from skin and eyes immediately. Do not smoke whilst using the product.

4.6 Adverse reactions (frequency and seriousness)

Treated rabbits may show a transient reduction in appetite in the 24-48 hours following treatment.

4.7 Use during pregnancy, lactation or lay

Not to be used in pregnant or breeding females.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

Rearguard comes supplied ready-to-use in a bottle with built-in applicator sponge. Gently depress the sponge to break the valve before applying.

Apply the product using the sponge applicator, ensuring that the rabbit’s fur is thoroughly wetted with the solution from the middle of the back to the tip of the tail. Special attention should be paid to the areas under the tail and between the back legs. Do not allow the product to run off the animal.

Rabbits should be first treated in early summer before any flies are seen. Rearguard will not kill adult maggots but works by preventing any eggs laid by flies developing.

Rabbits should be treated at 8-10 week intervals under conditions of repeated blowfly challenge. Bathing or washing the rabbit after application may result in a reduction of efficacy.

In cases of existing flystrike, adult maggots should be removed by mechanical means and appropriate supportive treatment given. Rearguard should then be applied to the fur to prevent development of new larvae and re-strike.

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

Not applicable.

4.11 Withdrawal period(s)

Not to be used on rabbits intended for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents Other ectoparasiticides for topical use

ATC Vet Code: QP53AX

5.1 Pharmacodynamic properties

Cyromazine is an insect growth regulator. It is not pharmacologically active in mammals.

5.2 Pharmacokinetic particulars

Dermal absorption rate a maximum of 10% of dose over 8 hours. Cyromazine rapidly excreted in mammals and birds.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl parahydroxybenzoate

Ethyl parahydroxybenzoate

Propyl parahydroxybenzoate

Lactic acid edible 80

Acetic acid glacial

Propylene glycol

Macrogol cetostearyl ether

Silicone emulsion

Water de-ionised

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of veterinary medicinal product as packaged for sale: 3 years

6.4 Special precautions for storage

Do not store above 25°C.

Protect from frost.

Protect from direct sunlight.

Shake the container before use.

Store in tightly closed original container.

Store away from food and drink.

6.5 Nature and composition of immediate packaging

A white pigmented HDPE bottle with a blue LDPE valve and white LDPE sponge applicator, closed with a white LDPE push cap containing 25ml of product.

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

Any unused veterinary medicinal product or waste materials derived from the use of the veterinary medicinal product should be disposed of in accordance with local requirements

7. MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd

Form 2, Bartley Way

Bartley Wood Business Park

Hook

RG27 9XA

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 00879/4009

9. DATE OF FIRST AUTHORISATION

20 June 2002

10. DATE OF REVISION OF THE TEXT

October 2020

Approved 16 October 2020