Zermasect Sheep Pour-On Alphacypermethrin 12.5 G/L Pour-On Solution
Revised: January 2015
AN: 01217/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zermasect Sheep Pour-On Alphacypermethrin 12.5 g/l pour-on solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Alphacypermethrin 12.5 g/l
Excipient(s):
Benzoic acid 1.0 g/l
Copper Chlorophyll Complex (E141) 0.6 g/l
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Pour-on solution.
Clear dark green liquid free from solids.
CLINICAL PARTICULARS
Target species
Sheep and Lambs
Indications for use, specifying the target species
For the control and treatment of blow fly strike, on sheep and lambs and for the treatment of lice and ticks on sheep. Reduces the incidence of headfly strike in sheep and lambs for up to 6 weeks.
Contraindications
Do not treat lambs under one week old and avoid treating animals in very hot weather.
Special warnings
None.
Special precautions for use
Special precautions for use in animals
Because alphacypermethrin is retained in the wool grease of the fleece, it is recommended that the product be applied to sheep with a minimum wool length of 1.0cm.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wear waterproof apron and boots and impervious gloves when applying the product and when handling recently treated animals
Use the product in a well-ventilated area
Washany splashes from the skin and eyes immediately, using plenty of water.
Remove heavily contaminated clothing immediately and wash before re-use
Wash hands and exposed skin with soap and water after treatment and before eating drinking and smoking.
Adverse reactions (frequency and seriousness)
Alphacypermethrin pour-on occasionally causes temporary irritation, lasting between 24 and 72 hours, in cattle. However no significant adverse reactions were recorded with sheep during the field trials for this product.
Discolouration of the fleece may be observed in some sheep from approximately 6 to 8 weeks after treatment.
Use during pregnancy, lactation or lay
Alphacypermethrin has low toxicity to mammals. There have been no tests of the effects of alphacypermethrin on foetal or lamb development.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
The product is applied at a rate of 40 mls for animals weighing 25 kg or more, and 25 mls for animals weighing less than 25 kg. The dose is applied using an adjustable dosing gun fitted with a T-bar with 3 or 4 outlets and is applied directly onto the wool in a band from the back of the head to the base of the tail. For the reduction of headfly strike 5mls per animal is applied between the horns, irrespective of size of the animal.
Blowfly – For the control of blowfly a single application will normally provide 8 to 10 weeks protection. Re-treatment may be necessary after this period. For the treatment of blowfly strike, a single treatment applied to the effected area will ensure blowfly larvae are killed.
Ticks – A single treatment will normally provide control of ticks for 8 to 12 weeks.
Headfly – A single treatment will reduce the incidence for up to 6 weeks.
Lice – A single treatment will normally kill all lice.
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DOSAGE (ml)
PEST
SHEEP (>25KG)
LAMBS (<25KG)
Blowfly
40
25
Lice
40
Ticks
40
Headfly
5
5
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were recorded in double dose exposure trials.
Withdrawal periods
Meat: 49 days
Milk: not for use in sheep producing milk for human consumption.
PHARMACOLOGICAL PROPERTIES
Active ingredient: alphacypermethrin
Therapeutic Group: ectoparasiticides; insecticides and repellents; pyrethrins; cypermethrin
ATCVet Code: QP53AC08
Pharmacological action: insecticide
Substance group: alpha-cyanopyrethroids
Mechanism of action: inhibits neural transmission in insects
Pharmacodynamic properties
Alphacypermethrin is a synthetic pyrethroid, which works as an insecticide and repellent by inhibiting neural transmission in insects.
Pharmacokinetic particulars
Alphacypermethrin is lipophyllic and is retained in the wool grease of the sheep fleece to provide protection from blowflies for up to 8 to 10 weeks.
PHARMACEUTICAL PARTICULARS
List of excipients
Benzoic acid
Copper Chlorophyll Complex (E141)
Phytorob 926/67
Incompatibilities
None known.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25°C.
Store in a dry place.
Store upright in the tightly closed original container.
Protect from direct sunlight.
Do not freeze.
If contents freeze they must be thawed and thoroughly mixed before use.
Store away from food, drink and animal feeding stuffs.
Nature and composition of immediate packaging
The container is a fluorinated HDPE backpack dispenser of 5 litre content.
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
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4168
DATE OF FIRST AUTHORISATION
Date:07 May 2008
DATE OF REVISION OF THE TEXT
Date:January 2015
APPROVED 15/01/15
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