Medine.co.uk

Vetzyme Jds 1% W/W Insecticidal Dog Shampoo

Revised: June 2011

AN: 02161/2010


SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF VETERINARY MEDICINAL PRODUCT


Vetzyme JDS 1% w/w Insecticidal Dog Shampoo


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Active Substance(s) % w/w

Permethrin (Technical) 1.000

Cis:trans 40:60


Excipients

Sodium Propyl Hydroxybenzoate 0.100 Antimicrobial preservative

Phenoxyethanol 0.800 Antimicrobial preservative

Green colourant 0.005 Colourant

{As Green Colouring W178680 OR :

Percol F731 Colourant

[Containing Patent Blue (E131) , Tartrazine (E102),

Sunset Yellow ((E110) and Sodium Chloride]}

For a full list of excipients, see section 6.1


3. PHARMACEUTICAL FORM


Shampoo

Green viscous liquid


CLINICAL PARTICULARS


4.1 Target Species


Dogs


4.2 Indications for use, specifying the target species


For the control of fleas on dogs.


4.3 Contra-indications


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 infest 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


Topical


Dosage Schedule


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.


Dosage Levels


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)


Not applicable.


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

Phenoxyethanol

Green Colouring [containing Patent Blue V (E131), Tartrazine (E102), Sunset Yellow (E110) & Sodium Chloride]

Triethanolamine Lauryl Sulphate Solution

Coconut Diethanolamide

SOS Bouquet 440860

Hydrogenated Castor Oil

Sodium Hydroxide 10%w/v (for pH adjustment)

Citric Acid Monohydrate 10%w/v (for pH adjustment)

Potable Water


6.2 Incompatibilities


None known.


6.3 Shelf-life


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.


iv) Protect from direct sunlight.

v) Protect from frost.


6.5 Nature and composition of immediate packaging


Vetzyme JDS 1% w/w Insecticidal Dog Shampoo 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


Harmful to fish and crustaceans. Do not contaminate aquaria or fish bowls with the product. Dispose of any waste water onto soil not used for growing vegetables.


Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


7. MARKETING AUTHORISATION HOLDER

Bob Martin (UK) Ltd.

Wemberham Lane

Yatton

Somerset

BS49 4BS

U.K.

8. MARKETING AUTHORISATION NUMBER


Vm00715/4098


9. DATE OF THE FIRST AUTHORISATION


Date:01 April 1992


10. DATE OF REVISION OF THE TEXT


Date:June 2011


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