Summary of Product Characteristics

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Revised:June 2010
ATC Vet Code Amended
Summary of Product Characteristics
1.
Name of the veterinary medicinal product
Foot Rot Aerosol – 10% w/w Cutaneous spray solution
2.
Qualitative and Quantitative composition
Active substance: Cetrimide
10%w/w
Excipients: Brilliant Blue (E133)
0.5%w/w
For a full list of excipients, see section 6.1
3.
Pharmaceutical form.
Cutaneous spray solution.
Clear blue liquid
4.
Clinical particulars.
4.1
Target species;
Sheep
4.2
Indications for use, specifying the target species;
As an aid in the treatment of foot rot in sheep.
4.3
Contra indication;
Avoid spraying in or near the eyes.
4.4
Special warnings for each target species;
For external use only.
4.5
Special precautions for use including special precautions to be
taken by the person administering the medicinal product to the
animals;
Highly flammable. Do not smoke when using this product.
Use in a well-ventilated area. Avoid inhaling spray mist.
Wash hands after use.
Avoid contact with the eyes. In the event of eye contact, wash
immediately with copious amounts of clean water. Seek medical advice
in irritation persists
Do not spray on a naked flame, or on incandescent material.
Revised:June 2010
ATC Vet Code Amended
4.6
Adverse reactions (frequency and seriousness);
None reported
4.7
Use during pregnancy, lactation or lay;
No problems expected.
4.8
Interaction with other medicinal products and other forms of
interaction;
Interaction with medicinal products – None reported.
Other - Inactivated by soaps and anionic substances.
4.9
Amounts to be administered and administration route;
Pare the feet thoroughly of each infected sheep, see that only healthy
horn remains. The removal of diseased horn may result in some
bleeding, but this is unavoidable. Spray each pared foot for one or two
seconds and return the sheep to a dry pen for about 1 hour before
returning to pasture. As foot rot is highly contagious, treated sheep
should not be returned to infected ground for at least a week if this can
possibly be avoided.
4.10
Overdose (symptoms, emergency procedures, antidotes) if
necessary;
Not likely
4.11
Withdrawal period for the various foodstuffs, including those for
which the withdrawal period is zero;
Sheep – Meat – Zero days
Milk – Zero hours
5.
Pharmacological Properties.
5.1
Pharmacodynamic properties;
ATCvet code: QD051
Pharmacotherapeutic Group: Products for the treatment of claws and
hoofs
Antiseptic – Cetrimide is chiefly tetradecyltrimethylammonium bromide
with smaller amounts of dodecyl and hexadecyl-trimentylammonium
bromides. It is a cationic surface active agent and is effective against
gram positive and at higher concentrations against some gram
negative bacteria and some fungi.
Revised:June 2010
ATC Vet Code Amended
5.2
Pharmacokinetic properties;
Cetrimide bonds strongly to collagen and keratin to form
cetrimide:protein complexes, consequently there is no significant
absorption after dermal application.
6.
Pharmaceutical particulars
6.1
List of excipients;
Brilliant Blue FCF (E133)
Diethyl phthalate
Denatured Ethanol B 100
Mowilith CT5A50% solution (co polymer of vinyl acetate/crotonic acid)
Carbon dioxide (propellant)
6.2
Incompatibilities
Inactivated by soaps and anionic substances.
6.3
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2
years
6.4
Special precautions for storage.
Pressurised container: protect from sunlight and do not expose to
temperatures exceeding 50°C
6.5
Nature and composition of immediate packaging.
Tinplate aerosol can with suitable PV00691 valve and actuator capable
of producing a discharge rate of 0.7 to 1.1g of product per second.
Contains 150g of concentrate.
6.6
Special precautions for disposal of unused veterinary medicinal
products 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.
7.
Marketing Authorisation holder.
Battle, Hayward and Bower Ltd
Crofton Drive,
Lincoln
LN3 4NP
Revised:June 2010
ATC Vet Code Amended
8.
Marketing Authorisation Number
Vm 00676/4100
9.
Date of the first authorisation
24th April 1992
10.
Date of revision of the text
June 2010
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