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Date: Friday, May 3, 2024 16:26

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.38
Flypor 4% w/v Pour-on Solution
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cattle
Active ingredient: Permethrin
Product:Flypor 4% w/v Pour-on Solution
Product index: Flypor 4% w/v Pour-on Solution
Cattle - milk: 6 hours
Cattle - meat: 3 days
Incorporating:
Qualitative and quantitative composition
Active ingredient
Permethrin tech. (cis:trans 80:20) 4.0%w/v
For a full list of excipients see Pharmaceutical Particulars.
Pharmaceutical form
Pour-on Solution.
Clear, straw coloured solution.
Clinical particulars
Target species
Cattle.
Indications for use, specifying the 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.
Contraindications
Do not treat calves under one week old.
Special warnings for each target species
As with all insecticides, the degree of fly-killing and repellent activity afforded by the product is influenced by prevailing weather conditions and the species of flies involved.
For external use only.
Special precautions for use
i. Special precautions for use in animals
Avoid the eyes when applying to the head.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wear protective clothing, rubber gloves and boots when applying the product.
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 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.
iii. Other precautions
Care should be taken when applying this product, as it may have an adverse effect on certain plastics.
The products must be applied only with the Elanco Cattle Pour-On Gun as the product may have a detrimental effect on certain components of conventional dosing guns.
Adverse reactions (frequency and seriousness)
None.
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.
Interaction with other medicinal products and other forms of interaction
No data available.
Amounts to be administered and administration route
Flypor 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 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Withdrawal period(s)
Meat: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 3 days from the last treatment.
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.
Pharmacological particulars
Pharmacotherapeutic group: Ectoparasiticides for topical use
ATC Vet code: QP53AC04
Pharmacodynamic properties
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.
Pharmacokinetic particulars
Synthetic pyrethroids are generally metabolized in mammals through ester hydrolysis, oxidation and conjugation and there is no tendency to accumulate in tissues.
Pharmaceutical particulars
List of excipients
Butyl dioxitol.
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Store in tightly closed original container.
Do not store above 25°C.
Store away from food, drink and animal feedstuffs.
Nature and composition of immediate packaging
250 ml, 500 ml & 1 litre pack
A natural, high density polyethylene bottle with integral graduated dispensing chamber, closed with a white, urea screw cap and foil induction seal.
1, 2, 2.5, 3, 4 & 5 litre flexi-pack
A white, opaque, high density polyethylene flex-pack closed with a white, polypropylene screw cap and foil induction seal.
Not all pack sizes may be marketed.
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 such veterinary medicinal products should be disposed of in accordance with local requirements.
Dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4008
Significant changes
Date of the first authorisation or date of renewal
11 April 1995
Date of revision of the text
January 2017
Any other information
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Flypor 4% w/v Pour-on Solution 1L
GTIN:05037694002787
GTIN description:Flypor 4% w/v Pour-on Solution 3L
GTIN:05037694002794
GTIN description:Flypor 4% w/v Pour-on Solution 4 x 3L
GTIN:05037694021573