Medine.co.uk

Rearguard 6% W/V Cutaneous Solution

Revised: December 2015

AN. 01134/2015


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 6.00


Other ingredients

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


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 25C.

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

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL


8. MARKETING AUTHORISATION NUMBER


Vm00879/4009


9. DATE OF FIRST AUTHORISATION


20 June 2002


10. DATE OF REVISION OF THE TEXT


December 2015


Approved: 15 December 2015


Page 4 of 4