Bob Martin Permethrin 1% W/W Flea Shampoo For Dogs
Revised: July 2012
AN: 00196/2012 & 00198/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF VETERINARY MEDICINAL PRODUCT
Bob Martin Permethrin 1% w/w Flea Shampoo for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance(s) % w/w
Permethrin (Technical) 1.000
Sodium Propyl Hydroxybenzoate………………...0.100
(As Green Colouring W178680 or Percol F731
Patent blue (E131)………………………………....0.0018
Sunset Yellow (E110)……………………………..0.0010)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Green viscous liquid
4.1 Target Species
4.2 Indications for use, specifying the target species.
For the control of fleas on dogs.
i) Do not use on cats
ii) Do not use on puppies under 12 weeks of age
iii) Do not use on nursing bitches
4.4 Special warnings for each target species
Remove fleas from young puppies and from nursing females by careful use of a flea comb.
4.5 Special precautions for use
i. Special Precautions for use in animals.
For external use only
Avoid contact with animal’s eyes
Wash any containers used thoroughly
Fleas from pets often infect animals’ baskets, bedding and regular resting areas such as carpets and soft furnishings. As part of a flea control programme these areas should also be treated with a suitable insecticide and vacuumed regularly.
ii. Special Precautions to be taken by the person administering the medicinal product to animals
Avoid prolonged contact with the skin. It is advisable to wear gloves whilst using this product.
Avoid contact with eyes. In case of accidental eye contact, rinse with clean, fresh water. If eye irritation persists, seek medical advice.
Treated animals should not be allowed to sleep or play with people, particularly children, until the animal is dry.
Keep away from food and drink including animal feeding stuffs.
Wash hands and exposed skin after use.
4.6 Adverse reactions (frequency and seriousness)
There are no recorded undesirable effects for this product.
4.7 Use during pregnancy, lactation or lay
Do not use on nursing bitches.
4.8. Interaction with other medicinal products and other forms of interaction
There are no recorded cases of any interaction with other medicinal products.
4.9 Amounts to be administered and administration route
Soak coat with warm water, apply about two-thirds of the shampoo, work in well avoiding eyes. Rinse, repeat application with the remaining volume of shampoo, working up lather. Rinse thoroughly. Dry with towel or hairdryer.
Small Breeds 20 – 30 ml
Medium Breeds 40 – 50 ml
Large Breeds 50 – 60 ml
Depending on the length of coat
4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary
There is very little likelihood of any acute overdosage
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES
ATCvet Code: QP53AC04
5.1 Pharmacodynamic properties
Permethrin is well recognised as a veterinary insecticide and has actions and uses similar to those of pyrethrum flower. The synthetic pyrethroids exert their action by unbalancing the parasite nerve fibres causing initial excitement followed by paralysis. Permethrin acts as a contact insecticide with rapid knockdown effect and some repellence against the flea
5.2 Pharmacokinetic properties
Not applicable as this product is for topical use.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Propyl Hydroxybenzoate
Green Colouring [containing Patent Blue V (E131), Tartrazine (E102), Sunset Yellow (E110) & Sodium Chloride]
Triethanolamine Lauryl Sulphate Solution
Hydrogenated Castor Oil
Sodium Hydroxide (for pH adjustment)
Citric Acid (for pH adjustment)
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special Precautions for Storage
i) Do not store above 25°C.
ii) Protect from light.
iii) Do not refrigerate.
from direct sunlight.
v) Protect from frost.
6.5 Nature and composition of immediate packaging
Bob Martin Permethrin 1% w/w Flea Shampoo for Dogs is packed in PVC or HDPE containers with high density polyethylene or polypropylene caps in 125 ml, 150 ml, 250 ml, 400 ml, 2, 2.25, 4, 4.5 and 22.5 litre sizes.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused medicinal products or waste materials derived from the use of such products if appropriate.
EXTREMELY DANGEROUS 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:
Bob Martin (UK) Ltd.
8. MARKETING AUTHORISATION NUMBER:
9. DATE OF THE FIRST AUTHORISATION:
Date:31 May 2001
10. DATE OF REVISION OF THE TEXT:
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