Revised 5 March 2009 – AN 01041/2008
1.Name of the veterinary medicinal product
Armitage Pet Care Flea Shampoo For Dogs
2.Qualitative and quantitative composition
Active Constituent:%w/v
Permethrin (cis:trans 25:75) (95% w/w)1.05
Also contains:
Tartrazine (E102) 0.0022% w/v and Amaranth (E123) 0.0004% w/v as colours.
Formaldehyde solution 0.21% w/v as a preservative.
3.Pharmaceutical form
Shampoo
4.Pharmacological properties
Permethrin, like other synthetic pyrethroids, is a neuropoison acting on the axons in the peripheral and central nervous system by interacting with sodium channels.
Permethrin is readily metabolised by man and animals, and is more potently toxic to ectoparasitic arthropods such as fleas because of the much slower rate of metabolism and elimination of the chemical by the ectoparasites.
ATC Vet Code: QP53AC04
5.Clinical particulars
5.1Target species
Dogs.
5.2Indications for use
For the control of fleas on dogs over 12 weeks of age.
5.3Contra-indications
Do not use on puppies under 12 weeks of age.
Do not use on cats.
Do not use on nursing bitches.
5.4Undesirable effects
None described.
5.5 Special precautions in use
For external use only.
Avoid contact with eyes.
5.6Use during pregnancy or lactation
Teratology studies in laboratory animals indicate that permethrin should pose no teratogenic risk in pregnant bitches. See also 5.8 for nursing bitches.
5.7 Interaction with other medicaments and other forms of interaction
None described.
5.8Posology and method of administration
Wet the coat with tepid water and work in the shampoo to form a good lather, using about 30ml for a medium sized dog. Alternatively, add 30ml shampoo to 600ml water and work the mixture into the dry coat of the dog. Additional water may be added as required when lathering. Leave for two minutes while the dog is held, rinse off with tepid water and allow to dry naturally.
If necessary repeat after seven days or until infestation is cleared.
Remove fleas from young puppies and nursing bitches by careful use of a flea comb.
Fleas from pets often infest animal’s basket and regular resting areas such as carpets and soft furnishings which should be treated with a suitable insecticide and vacuumed regularly.
5.9Overdose
Dogs treated with 3 x the recommended dose showed no signs of clinical toxicity or irritation.
5.10Special warnings
None.
5.11Withdrawal period
Not applicable.
5.12Special precautions to be taken by person administering the product to animals
Avoid contact with eyes and rinse all splashes from eyes with plenty of water.
Avoid prolonged contact with skin. Rinse all splashes from skin with plenty of water.
It is advisable to wear gloves whilst using this product.
Wash hands after use.
Do not contaminate food and drink.
6.Pharmaceutical particulars
6.1Incompatibilities
None described.
6.2Shelf-life
30 months
6.3Special precautions for storage
Protect from frost. Protect from direct sunlight.
Store in an upright position. Store in a dry place.
6.4Nature and contents of container
Size: 100ml and 240ml.
Container:White high density polyethylene bottle with sifter top
Closures:Polypropylene screw cap-closure.
Not all pack sizes may be marketed.
6.5Special precautions for disposal of unused productor waste material, if any
Harmful to fish and crustaceans. Do not contaminate aquaria or fish bowls with the product.
Any unused product or waste material should be disposed of in accordance with national requirements.
7.0Further information
Name and address of authorisation holder
Bio-Tech Solutions Ltd
Windmill Works
Kelleythorpe Industrial Estate
Driffield
East Yorkshire
YO25 9DJ
Marketing Authorisation Number:Vm 20889/4006
Date of last revision of the SPC:5 March 2009
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Date of First Authorisation:4 August 2003