Summary of Product Characteristics

Vectocert 1.25% w/v Pour-On Solution for Sheep

Active Substance % w/v

Cypermethrin High:Cis (80:20) 1.25

Excipients

Green s Dye (E142) 0.02

Pour-On Solution.

Clear blue non-aqueous solution.

4. Clinical Particulars

Sheep.

4.2 Indications for use, Specifying the Target Species

For the treatment and control of headflies, and treatment of ticks and biting lice in sheep. For the prevention and treatment of blowfly strike in sheep.

4.3 Contraindications

Not to be used in lambs less than one week old.

For the prevention of blowfly strike; do not administer to animals of less than 12.5 kg bodyweight.

Avoid treating very young lambs if the weather is unseasonably hot.

4.4 Special Warnings for Each Target Species

None

4.5 Special Precautions For Use

i) Special precautions for use in animals

Vectocert 1.25% w/v Pour-On Solution for Sheep minimises mothering-up problems after treatment. However, care must be taken not to apply the product right to the lamb’s tail, as a ewe recognises a young lamb partly by the smell of the tail area.

Blowflies are attracted by dirty, damp wool or open wounds. The more common site for fly strike is the rump due to soiling caused by diarrhoea and urine staining. The efficacy of Vectocert 1.25% w/v Pour-On is reduced in the presence of soiled or dirty wool. Therefore, sheep must be crutched(dagged) regularly and appropriate worm control measures employed.

Take care not to apply product in the sheep’s eyes. This precaution should be observed particularly when treating breeds with little wool on their heads.

Full operating and maintenance instructions, including details on the use of nozzles are supplied with each applicator gun. Please read carefully before use. Maintain applicator gun carefully to ensure accurate dosage.

For external use only.

ii) Special Precautions to be taken by the person administering the product to animals

Make sure when attaching the recommended applicator gun onto the container that the coiled retainer is secured onto the cap and the applicator.

Wear eye protection, protective clothing, rubber gloves and boots when

applying the product.

Wear a disposable mask when applying as a fan-spray for the prevention of blowfly-strike.

Wash splashes from skin and eyes immediately with plenty of clean water. If irritation persists seek medical advice immediately

Remove contaminated clothing immediately and wash exposed skin with plenty of clean water.

Do not eat, drink or smoke whilst using the product.

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

Use in a well-ventilated area and avoid inhaling the vapour.

iii) Other precautions

As a precautionary measure sheep must be kept away from watercourses for at least one hour following treatment (see section 5.3, ‘Environmental properties’).

4.6 Adverse Reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy or lactation

No restrictions. Pregnant ewes must be handled with care.

4.8 Interaction with other medicinal products and other forms of interaction

The product must be applied only with the recommended applicator gun, as the product may have a detrimental effect on certain components of conventional dosing guns.

4.9 Amounts to be administered and administration route

On completion of each treatment cycle of the product and before the dosing gun is stored, immediately expel any remaining product in the dosing gun.

Administer by means of the recommended applicator gun as follows:

Blowflies:

Prevention of blowfly strike

Bodyweight Dose Doses per litre

Up to 25 kg* 20 ml 50

25 to 40 kg 30 ml 33

Over 40 kg 40 ml 25

*Do not administer to animals of less than 12.5 kg bodyweight.

Apply as a fan-spray to the surface of the fleece on the back and hindquarters of the sheep using the Pour-On Gun fitted with the fan-spray nozzle. Half the dose should be applied to the shoulders, back and flanks, and half to the rump. The distance between the nozzle and the fleece should be approximately 20 cm. Each dose will require 2 or 3 sweeps to apply. THE PRODUCT WILL PREVENT BLOWFLY STRIKE ONLY ON AREAS COVERED BY SPRAY. One application will give 6-8 weeks protection. Re-treat as required.

Treatment of blowfly strike

Apply directly to all the affected parts at the rate of 2.5 ml per 100 –150 cm²(roughly the size of a hand). The T-bar nozzle should be used. Most strikes will require 5-10 ml. Ensure that all affected parts are treated. A single application is sufficient to ensure that larvae are expelled and killed within a few hours.

Lice: 5 ml per 20 kg bodyweight up to a maximum of 20 ml.

Bodyweight Dose Doses per litre

Up to 20 kg 5 ml 200

21 to 40 kg 10 ml 100

41 to 60 kg 15 ml 66

Over 60 kg 20 ml 50

Using the straight nozzle on the applicator gun, apply as a pin-stream from the shoulders to the rump along the middle of the backline.

Sheep may be treated off-shears or at any time during the year.

Ticks: Adult sheep and lambs greater than 10 kg: 10 ml per 20 kg bodyweight, up to a maximum of 40 ml. Lambs under 10 kg: 5 ml followed 3 weeks later by a 10 ml application.

Bodyweight Dose Doses per litre

Up to 10 kg 5 ml 200

11 to 20 kg 10 ml 100

21 to 40 kg 20 ml 50

41 to 60 kg 30 ml 33

Over 60 kg 40 ml 25

Using the straight nozzle on the Pour-On Gun, apply as a pin-stream from the crown of the head to the top of the rump.

Headflies: 5 ml per animal irrespective of size.

Apply to the top of the head between the ears using the T-bar nozzle.

Take care not to apply product in the sheep’s eyes.

One application before the start of the headfly season will give up to 4 weeks protection. Re-treat as required.

This product contains a blue dye to aid in the identification of treated animals. The colour is temporary and will fade from the fleece within 48 hours of application.

4.10 Overdose

Toxic signs in mammals are tremors, hyperexcitability, salivation, choreoathetosis and paralysis, rarely leading to death. Usually, 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 Periods

Meat and offal: 8 days.

Milk: Not to be administered to animals producing milk for human consumption.

5. Pharmacological Properties

ATCvet code: QP53AC08

Pharmacotherapeutic group: ectoparasiticides for topical use, incl. Insecticides.

5.1 Pharmacodynamic Properties

Cypermethrin is a neuropoison acting on the axons in the peripheral and central nervous system of insects by interacting with sodium channels.

5.2 Pharmacokinetic Properties

Synthetic pyrethroids are generally metabolised in mammals through ester hydrolysis, oxidation and conjugation and there is no tendency to accumulate in tissues.

5.3 Environmental Properties

Cypermethrin is moderately persistent and non-mobile in soil. It is extremely toxic to aquatic invertebrates. Cypermethrin is toxic to dung insects. Long term effects on dung insects caused by continuous or repeated use of the product cannot be excluded.

None known.

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

24 months.

Shelf life after first opening of the immediate packaging: 3 months.

Do not store above 25°C. Protect from direct sunlight. Store in tightly closed original container.

Store away from food, drink and animal feeding stuffs.

The product is provided in white high-density polyethylene Carrick Flat Bottom Containers with polypropylene closures and induction heat-sealed wadding, at 1 litre, 2.5 litre and 5 litre pack sizes.

Not all pack sizes may be marketed.

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

Extremely dangerous to aquatic invertebrates. Do not contaminate ponds, waterways or ditches with the product or empty container.

Cross Vetpharm Group Ltd.

Broomhill Road

Tallaght

Dublin 24

Ireland

8. Marketing Authorisation Number

Vm 12597/4059

9. Date of First Authorisation

13 April 2012

10. Date of Revision of the Text

April 2012