SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Z-Itch

40 mg/ml Pour-on Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Permethrin (80:20) technical 40.0 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Pour-on solution.

A clear, colourless to pale yellow, non-aqueous solution.

4. CLINICAL PARTICULARS

4.1 Target species

Horses and donkeys.

4.2 Indications for use, specifying the target species

For the control of the biting insect Culicoidesspp. This product may be used as an aid in the control of sweet itch

4.3 Contraindications

Do not administer to horses and donkeys intended for human consumption.

Do not treat the saddle area.

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

4.4 Special warnings for each target species

Sweet itch is believed to be caused by hypersensitivity to the bites of flying insects e.g. Culicoides species. In addition to treatment, other measures should be taken to reduce exposure to such insects where practicable. It may be appropriate for owners to seek veterinary advice on management of horses with sweet itch. It is also recommended thatowners seek veterinary advice in severe cases of sweet itch and in cases of sweet itch which do not respond to treatment.

4.5 Special precautions for use

Special precautions for use in animals

For external use only.

The product must not be applied forward of the ears.

Take care to avoid eye contact.

In case of accidental splashing into the horse's eye, the affected eye should be washed thoroughly and immediately with copious quantities of clean water and veterinary attention sought.

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

The product may cause transient skin and eye irritation.

Wear protective clothing, boots and chemically resistant gloves such as rubber, PVC or nitrile when applying the product. Wash splashes from skin and eyes immediately.

When using the product do not eat, drink or smoke.

Wash hands and exposed skin before eating, drinking or smoking and after work.

Use in a well ventilated area.

Keep away from food, drink and animal feeding stuffs.

4.6 Adverse reactions (frequency and seriousness)

A few horses, particularly those of the fine-skinned Arab type, may react adversely to treatment with the product. In such individuals a small patch test at the base of the neck is recommended. If adverse reactions should occur, treatment should be stopped immediately. Any resulting skin irritation is short lived.

Procedure for patch testing

Using protective gloves apply a small quantity of the product (about 1 ml) to an identifiable area at the base of the animal’s neck and rub onto the skin with a swab. Wrap the used swab in the gloves and dispose of safely. At 24 and 48 hours after application, examine the area to which the product was applied and observe the skin for signs of reaction (redness, swelling, flaking or exudation). If a reaction occurs, do not use the product on the animal.

4.7 Use during pregnancy, lactation or lay

No special precautions required.

4.8 Interaction with other medicinal products and other forms of interaction

Care should be taken when applying the product as it may have an adverse effect on certain plastics.

4.9 Amounts to be administered and administration route

Horses and donkeys: 4 mg/kg body weight, equivalent to 1.0 ml per 10 kg bodyweight

to a maximum of 4 0 ml.

Dosage guidelines

Body weight (kg)	100	200	250	300	>400
Dose volume (ml)	10	20	25	30	40

Apply the measured dose in approximately equal proportions to the mane and rump avoiding the saddle area. Treatment should be started at the beginning of the sweet itch season and repeated as necessary - treatment once weekly should be sufficient for most horses.

If horses and donkeys are to be groomed, apply the product after grooming.

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

Toxic signs in mammals are tremors, hyperexcitability, salivation, choreoathetosis and paralysis. The signs disappear rapidly and the animals recover, generally within a week. There is no specific antidote but symptomatic therapy can be given if considered necessary.

4.11 Withdrawal period(s)

Not to be used in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under the national horse passport legislation.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticide.

ATCvet code: QP53AC04.

5.1 Pharmacodynamic properties

Permethrin is a neurotoxin affecting the axons in the insect peripheral and central nervous system by interaction with sodium channels.

5.2 Pharmacokinetic particulars

The product is indicated for cutaneous administration. Following topical application to the animal, the solution is distributed over the skin.

Synthetic pyrethroids are generally metabolised in mammals through ester hydrolysis, oxidation and conjugation and there is no tendency for tissue accumulation.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butyl dioxitol.

6.2 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.

6.4. Special precautions for storage

Do not store above 25°C.

Store in tightly closed original container in a dry place.

Protect from light.

6.5 Nature and composition of immediate packaging

Container size:	250 ml.
Container material:	Natural, high density polyethylene.
Closure:	White, polypropylene screw fit cap with induction seal.
Dosing device:	Integral graduated dispensing chamber.

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

Dangerous to fish and other aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Floris Veterinaire Produkten BV

Kempenlandstraat 33 / 35

5262 GK Vught

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 36057/4000

9. DATE OF FIRST AUTHORISATION

27 January 2011

10. DATE OF REVISION OF THE TEXT

August 2016

16 August 2016