SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Flypor 40 mg/ml Pour-on Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Permethrin technical (cis:trans 80:20) 40 mg Excipient:

Qualitative composition of excipients and other constituents

Butyl dioxitol

Clear, straw-coloured liquid.

3. CLINICAL INFORMATION

3.1 Target species

Cattle.

3.2 Indications for use for each target species

For the control of flies (particularly biting flies and horn-flies) and lice (including sucking and biting lice), and for the treatment of sarcoptic and chorioptic mange of cattle.

3.3 Contraindications

Do not treat calves under one week old.

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

3.4 Special warnings

As with all insecticides, the degree of fly-killing and repellent activity afforded by the veterinary medicinal product is influenced by prevailing weather conditions and the species of flies involved.

For external use only.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Avoid the eyes when applying to the head.

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

Personal protective equipment consisting of waterproof apron, impervious gloves and boots should be worn when handling the veterinary medicinal product and recently treated animals.

Avoid contact with the eyes. If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.

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

Wash hands and exposed skin before eating, drinking or smoking and after work. Use in a well-ventilated area. Do not inhale the vapour.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Care should be taken when applying this veterinary medicinal product, as it may have an adverse effect on certain plastics.

The veterinary medicinal product must be applied only with the Elanco Cattle Pour-On Gun as the veterinary medicinal product may have a detrimental effect on certain components of conventional dosing guns.

3.6 Adverse events

None known.

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.

3.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy.

Use only according to the benefit/risk assessment of the responsible veterinary surgeon.

3.8 Interaction with other medicinal products and other forms of interaction

No data available.

3.9 Administration routes and dosage

The veterinary medicinal product is a ready-to-use solution which should be applied at the rate of 1 ml per 10 kg bodyweight up to a maximum of 40 ml.

Bodyweight	Dose
Calves up to 100 kg	10 ml
101 to 200 kg	20 ml
201 to 300 kg	30 ml
Over 300 kg	40 ml

The veterinary medicinal product should be applied using either the calibrated dispensing chamber incorporated into the applicator bottle, or the flexi-pack with a Elanco Cattle Pour-On Gun.

Flies: Apply approximately one quarter of the calculated dose to the top of the head; the remainder should be poured along the neck and mid-backline.

A single dose is normally sufficient to control flies for up to 8 weeks. The first treatment should be carried out when the number of flies start to increase. In cases of heavy infestation, the dose may be repeated at 4-week intervals.

Lice: Apply in the same way as fly dosage. A single dose is normally sufficient to control all lice. In certain cases of heavy infestation, the dose may be repeated after 4 weeks.

Sarcoptic and chorioptic mange: The calculated dose should be applied directly to all visibly affected areas; any remaining should be poured along the backline in the normal way. The dose should be repeated after 4 weeks.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Toxic signs in mammals are tremors, hyperexcitability, salivation, chorea, athetosis 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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Meat and offal: 3 days.

Milk: Cattle producing milk for human consumption should be treated immediately after milking to allow as long an interval as possible (at least 6 hours) before the next milking.

There is no need to withhold milk from subsequent milkings.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QP53AC04

4.2 Pharmacodynamics

Permethrin is a neuropoison acting on the axons in the peripheral and central nervous system by interacting with sodium channels in insects. In vitro data obtained using hair from treated animals has demonstrated that the product has the potential to be effective against Culicoides biting midges, although this has not been confirmed by clinical trials.

4.3 Pharmacokinetics

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

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

None known.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

5.3 Special precautions for storage

Do not store above 25 °C.

Store in the original container.

Keep the container tightly closed.

Store away from food, drink and animal feedstuffs.

5.4 Nature and composition of immediate packaging

250 ml, 500 ml & 1 litre	High-density polyethylene bottle with integral graduated dispensing chamber, closed with a urea screw cap and foil induction seal.
1, 2, 2.5, 3, 4 & 5 litre	High-density polyethylene flexi-pack closed with a polypropylene screw cap and foil induction seal. The 3-litre flexi-pack is supplied in a cardboard carton.

Not all pack sizes may be marketed.

5.5 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.

The veterinary medicinal product should not enter water courses as permethrin may be dangerous for fish and other aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Elanco GmbH

7. MARKETING AUTHORISATION NUMBER

Vm 52127/5067

8. DATE OF FIRST AUTHORISATION

11 April 1995

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

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

Approved: 04 August 2026