Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ectospec 2.5% Pour-On Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Cypermethrin Technical (93% w/w; cis/trans isomers 50 : 50) 2.5% w/v
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on solution.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle.
4.2 Indications for use, specifying the target species
For control of lice and flies.
4.3 Contraindications
Do not treat calves under 7 days of age.
Not to be used in animals known to be hypersensitive to the active ingredient.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
As per the special safety precautions to be taken by the person administering the product to animals listed in 4.11
below.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Ectospec should be administered in a well-ventilated area. Protective clothing, including rubber gloves, should be worn
and any accidental splashes should be washed off immediately.
Do not eat, drink or smoke when applying Ectospec. Wash hands and any exposed skin immediately after application
has finished.
4.6 Adverse reactions (frequency and seriousness)
Occasionally, slight signs of discomfort may be observed in some cattle during the 48 hours following application.
These side-effects are only temporary and have no long-term implications.
4.7 Use during pregnancy, lactation or lay
The active has a low oral activity and very little transdermal absorption is expected. To date there have been no
reported complications in pregnancy or lactation.
4.8 Interaction with other medicinal products and other forms of interaction
It is not anticipated that Ectospec will interact with any of the medicines commonly administered to cattle.
4.9 Amounts to be administered and administration route
For topical administration as a pour-on
LICE CONTROL
A single 10 ml dose is normally sufficient to control lice. A few lice may survive on a small minority of animals. In
cases of heavy challenge, if necessary, a repeat dose may be applied after 4 weeks.
Remove the cap from the chamber and gently squeeze the required amount into the chamber. Release the pressure
from the container and pour as directed.
The 10 ml dose should be applied at an even rate along the backline from the crown of the head to the top of the rump.
FLY CONTROL
Apply a single 10ml dose at the onset of the fly season and repeat as necessary at 5 to 8 week intervals. Frequency of
administration may, however, have to be varied depending on the level and type of infestation.
The 10 ml dose should be applied at an even rate along the backline from the crown of the head to the top of the rump.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Care should be taken not to overdose. Overdosing may invalidate the stated milk and meat withholding times as
in 4.11 below.
4.11Withdrawal Period(s)
Animals must not be slaughtered for human consumption during treatment. Treated animals should not be slaughtered
for human consumption for a period of 10 days after treatment.
No withdrawal time is necessary for milk, although cows should be treated immediately after milking to allow as long a
time as possible to elapse before the next milking.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Cypermethrin is a synthetic pyrethroid insecticide used for both crop protection and to control ectoparasites on
livestock.
Cypermethrin is a contact poison, having a rapid paralytic action on insects, preceded by muscular excitation and
convulsions. The pyrethroids have sufficient stability to have a prolonged effect when applied to the animal.
Cypermethrin is not systemically active when used as a “pour-on” preparation. When applied in this manner, the
product spreads over the surface of the animal.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Myritol (Triglyceride, Medium-Chain Ph. Eur.)
6.2 Incompatibilities
Incompatible with alkali materials.
6.3 Shelf-life
2 years.
6.4 Special precautions for storage
Do not store above 25oC.
6.5 Nature and composition of immediate packaging
High density polyethylene multi-dose 500 ml (with graduated measuring compartment) and 2.5L container. Each
container is sealed with an aluminium tamper-evident seal and a plastic cap. Both containers contain the relevant
volume of an oily-based clear, pale yellow pour-on solution.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Dangerous to fish and other aquatic life.
Do not contaminate ponds, waterways or ditches with the product or used containers.
Unused product and containers should be disposed of in accordance with current practice for pharmaceutical waste
under national waste disposal regulations.
7 MARKETING AUTHORISATION HOLDER
Bimeda Holdings Plc.,
Broomhill Road,
Tallaght,
Dublin 24.
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10959/10/1
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11th July 2005
10 DATE OF REVISION OF THE TEXT
8th June 2009
