Armitage Pet Care Insecticidal Flea Shampoo And Conditioner
Revised: December 2010
AN: 00868/2010
Name of the veterinary medicinal product
Armitage Pet Care Insecticidal Flea Shampoo & Conditioner
Qualitative and Quantitative Composition
Active Ingredient % w/w
Pyrethrum 25% Extract 0.190
(equivalent to Pyrethrins 0.0475)
Piperonyl Butoxide (100%) 0.490
Other Ingredients % w/w
Bronidox L 0.130
Carmoisine (E122) 0.0032
Pharmaceutical form
Shampoo
Red, clear shampoo, pH 6.0
Clinical Particulars
4.1 Target species
Dogs over 12 weeks of age.
Indications for use, specifying the target species
For the control of fleas on dogs and puppies over 12 weeks of age.
4.3 Contra-indications
Do not use on cats
Do not use on puppies under 12 weeks of age.
Do not use on nursing females.
4.4 Special warnings for each target species
To help prevent re-infestation, dog’s bedding, basket and regular resting areas such as carpets and soft furnishings should be treated with a suitable insecticide and vacuumed regularly. Remove fleas from young puppies and nursing females by careful use of a flea comb. If signs of disease persist or appear, consult a veterinary surgeon.
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals
Special precautions for use in animals
For external use only.
Avoid contact with eyes.
Special precautions to be taken by the person administering the medicinal product to animals
Wash hands and exposed skin after use.
Avoid contact with eyes. In case of accidental eye contact, rinse with clean, fresh water. If eye irritation persists, seek medical advice.
Persons who are hypersensitive (allergic) to pyrethrum extract should handle the product with care.
Treated animals should not be allowed to sleep or play with people especially children until the animal is dry.
Keep away from food and drink including animal feeding stuffs.
Adverse reactions (frequency and seriousness)
None reported.
4.7 Use during pregnancy, lactation or lay
Do not use on nursing females.
Interaction with other medicinal products and other forms of interaction
Other insecticides should not be used concurrently.
Amounts to be administered and administration route
Mix the recommended amount of shampoo with 300ml of lukewarm water. Wet the dog’s coat thoroughly with warm water and apply half of the mixture. Massage well into the coat, using fingertips around the head to avoid eyes, ears and mouth. Rinse and repeat with the remainder of the mixture working up to a good lather. Rinse well with lukewarm water and towel dry, then brush and comb thoroughly. Repeat in 7 days if necessary.
Recommendations:
Use 30ml of shampoo for a small dog (e.g. Terrier)
Use 50ml of shampoo for a medium dog (e.g. Collie).
Use 70ml of shampoo for a large dog (e.g. Alsatian).
Overdose (symptoms, emergency procedures, antidotes) if necessary
In cases of adverse reaction, consult a veterinary surgeon.
Withdrawal period(s)
Not applicable
Pharmacological properties
Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. Insecticides.
ATCvet Code: QP53AC51
5.1 Pharmacodynamic properties
The shampoo is a liquid formulation containing the active ingredient Pyrethrins (from Pyrethrum Pale Extract (25%)). Pyrethrum is rapidly toxic to many insects, including fleas.
5.2 Pharmacokinetic particulars
The pyrethroids possess potent insecticidal activity with much lower mammalian toxicity.
Pharmaceutical particulars
List of excipients
Bronidox L (preservative)
Carmoisine (E122)
Water potable
Sodium lauryl ether sulphate
Coconut Diethanolamide
Sodium Chloride
Solan E50
Perfume
Citric acid monohydrate
Incompatibilities
None
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 1 year
Special precautions for storage
Close the bottle, store it upright. Protect from frost. Protect from direct sunlight.
Keep away from food and drink and animal feeding stuffs.
Nature and contents of immediate packaging
Container: food grade polymer PVC (clear) with HDPE screw cap.
Contents 250ml.
Labelled according to the conditions of the Marketing Authorisation.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Harmful to fish and crustaceans. Do not contaminate aquaria or fish bowls with the product.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing authorisation holder
Sinclair Animal and Household Care Ltd.
Ropery Road
Gainsborough
Lincolnshire
DN21 2QB
Marketing authorisation number
Vm 16516/4034
Date of renewal of the authorisation
5 June 2011
Date of any revision of the text
December 2010
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