SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the Veterinary Medicinal Product
Exspot
2.
Qualitative and Quantitative Composition
Active ingredient
Permethrin (cis:trans 40:60)
3.
706 mg/sachet
Pharmaceutical Form
Cataneous Solution: A clear, amber, ready-to-use topical ectoparasiticide solution.
4.
Pharmacological Properties
Pharmacodynamics
The active ingredient permethrin (cis:trans 40:60) is an insecticidal, synthetic
pyrethroid which selectively disrupts nerve transmission in insects.
Permethrin exerts its activity by causing a change in insect nerve membrane
permeabilities to sodium and potassium.
Permethrin is readily metabolised by man and animals, and is more potently toxic
to ectoparasitic arthropods such as flies, lice, fleas, ticks and mites because of the
much slower rate of metabolism and elimination of the chemical by the
ectoparasites.
5.
Clinical Particulars
5.1
Target Species
Dogs
5.2
Indications for Use
For the treatment and control of fleas and ticks on dogs. Exspot kills fleas
and ticks and provides protection from reinfestation for up to four weeks
after application.
5.3
Contra-indications
Do not use on puppies under 2 weeks of age.
DO NOT USE ON CATS. This product is poisonous to cats.
5.4
Undesirable Effects
Following treatment of a small minority of dogs, a transient, localised
irritation at the site of application or nervous signs have been reported.
Should this occur, then bathe the dog with a detergent-based shampoo and
seek veterinary advice immediately.
5.5
Special Precautions for Use
For external use only.
Do not use in animals known to be hypersensitive to the active substance.
5.6
Use During Pregnancy and Lactation
Teratology studies in laboratory animals indicate that permethrin should
pose no teratogenic risk in pregnant bitches.
5.7
Interaction with other Medicaments and other forms of Interaction
None described.
5.8
Posology and Method of Administration
For dogs weighing up to and including 15 kg:
Part the coat between the shoulder blades until the skin is visible.
Squeeze 1 ml (the contents of one tube) directly onto the skin. Avoid
application to fur. Avoid the contents coming into direct contact with
fingers.
For dogs weighing more than 15 kg:
Part the coat between the shoulder blades until the skin is visible.
Squeeze 1 ml (the contents of one tube) directly onto the skin. Avoid
application to fur. Avoid the contents coming into direct contact with
fingers.
Apply 1 ml in a similar manner at the root of the tail.
The product may be safely applied at intervals of not less than seven
days.
Fleas from pets often infest an animal’s basket, bedding and regular
resting areas such as carpets and soft furnishings, which should be
treated with a suitable insecticide and vacuumed regularly.
5.9
Overdose (symptoms, emergency procedures, antidotes)
Dogs treated with 4 x the recommended dose showed no adverse effects.
5.10
Special Warnings for each Target Species
Do not use on puppies under 2 weeks of age. Avoid application to fur. This
product must not be massaged into the skin.
Treated dogs should not be allowed to go swimming for 12 hours after
treatment.
This product is not suitable for use on the cat. In using insecticide, it is
important to ensure that cats do not groom the site of application on a dog
which has been treated with this product. Should this occur, separate the
animals and seek veterinary advice.
5.11
Withdrawal Period
Not applicable.
5.12
Special Safety Precautions to be taken by the Person Administering the
Product to Animals
Avoid contents coming into direct contact with fingers. Avoid contact with
the skin and eyes. Wash hands after use. Wash off any splashes
immediately.
Users making multiple applications, for example in kennels, should wear
protective gloves made of neoprene or nitrile and of minimum thickness 0.3
mm.
Do not handle the area of application for 3-6 hours after treatment.
It is preferable to treat during the evening.
Treated dogs should not be allowed to sleep with people, particularly
children.
Do not remove container from backing card at any time.
6.
Pharmaceutical Particulars
6.1
Major Incompatibilities
None described.
6.2
Shelf Life
2 years.
6.3
Special Precautions for Storage
Protect from light.
Do not refrigerate.
Do not store above 25°C.
6.4
6.5
Nature and Contents of Container
Size:
:
6 x 1 ml Sachet.
Container/closures
:
Plasticised vinylidene chloride/vinyl chloride
copolymer.
Special Precautions for the Disposal of Unused Medicinal Product or Waste
Materials, if any
None.
Extremely dangerous to fish. Do not contaminate ponds, waterways or
ditches with the product or packaging.
7.
Final Information
Name and Permanent Address of the Holder of the Authorisation to Market the
Product
Schering Plough Animal Health
Division of Schering–Plough Ltd
Welwyn Garden City
AL7 1TW
a)
Marketing Authorisation:
Vm 00201/4086
b)
Legal Category:
GSL