Imidamox 80 mg/8 mg Spot-on Solution for Large Cats

Brief contact of the animal with water on one or two occasions between monthly
treatments is unlikely to significantly reduce the efficacy of the product. However,
frequent shampooing or immersion of the animal in water after treatment may reduce
the efficacy of the product.
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class. Therefore, the use of this
product should be based on the assessment of each individual case and on local
epidemiological information about the current susceptibility of the target species in
order to limit the possibility of a future selection for resistance.
The use of the product should be based on the confirmed diagnosis of mixed
infection (or risk of infection, where prevention applies) at the same time (see also
sections 4.2 and 4.9).
4.5 Special precautions for use
Special precautions for use in animals
There is limited experience on the use of the product in sick and debilitated animals,
thus the product should only be used based on a benefit-risk assessment for these
animals.
The product should only be applied to undamaged skin.
Care should be taken that the content of the pipette or the applied dose does not
come into contact with the eyes or mouth of the recipient and/or other animals. Do
not allow recently treated animals to groom each other. Oral uptake by Collie or Old
English Sheep dogs and related breeds or crossbreeds should be prevented.
It is recommended that cats living in, or travelling to areas endemic for heartworm are
treated monthly with the product to protect them from heartworm disease.
Whilst the accuracy of diagnosis of heartworm infection is limited, it is recommended
that attempts be made to check the heartworm status of any cat aged over 6 months,
before beginning prophylactic treatment, as use of the product on cats which have
adult heartworms may cause serious adverse effects, including death. If adult
heartworm infection is diagnosed, the infection should be treated in accordance with
current scientific knowledge.
In certain individual cats Notoedres cati infestation may be severe. In these severe
cases concomitant supportive treatment is necessary as treatment with the product
alone may not be sufficient to prevent death of the animal.
Imidacloprid is toxic for birds, especially canaries.

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Special precautions to be taken by the person administering the veterinary medicinal
product to animals
In order to prevent children from getting access to pipettes, keep the pipette in the
original packaging until ready for use and dispose of used pipettes immediately.
Do not ingest. In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the label to the physician.
People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin
should administer the product with caution. In very rare cases the product may cause
skin sensitisation or transient skin reactions (for example numbness, irritation or
burning/tingling sensation).
In very rare cases the product may cause respiratory irritation in sensitive individuals.
If the product accidentally gets into eyes, they should be thoroughly flushed with
water.
Avoid contact with skin, eyes or mouth.
In case of accidental spillage onto skin, wash off immediately with soap and water.
Wash hands thoroughly after use.
If skin or eye symptoms persist, seek medical advice immediately and show the
package leaflet or label to the physician.
Do not eat, drink or smoke during application.
Treated animals should not be handled, especially by children, until the application
site is dry. Therefore, it is recommended to apply the product in the evening.
Recently treated animals should not be allowed to sleep in the same bed as their
owner, especially children.
The solvent in the product may stain or damage certain materials including leather,
fabrics, plastics and finished surfaces. Allow the application site to dry before
permitting contact with such materials.
4.6 Adverse reactions (frequency and seriousness)
Use of the product may result in transient pruritus in cats. On rare occasions greasy
fur, erythema and vomiting can occur. These signs disappear without further
treatment. The product may, in rare cases, cause local hypersensitivity reactions. If
the animal licks the application site after treatment, neurological signs (most of which
are transient) may be observed in very rare cases (see section 4.10).
The product tastes bitter. Salivation may occasionally occur if the animal licks the
application site immediately after treatment. This is not a sign of intoxication and
disappears within some minutes without treatment. Correct application will minimise
licking of the application site.
The product may in very rare cases cause at the application site a sensation resulting
in transient behavioural changes such as lethargy, agitation, and inappetence.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not
produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Use only according to the benefit-risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
During treatment with the veterinary medicinal product no other antiparasitic
macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used
veterinary medicinal products or medical or surgical procedures have been observed.
4.9 Amounts to be administered and administration route
For external use only (spot-on use).
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 1.0
mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary
medicinal product.
The treatment schedule should be based on individual veterinary diagnosis and on
the local epidemiological situation.
Administer in accordance with the following table:
Cats
[kg]
Pipette size to be used
Volume
[ml]
Imidacloprid
[mg/kg b.w.]
Moxidectin
[mg/kg b.w.]
>4-8
imidacloprid/moxidectin 80 mg/8
mg spot-on solution for cats
0.810-201-2
>8
the appropriate combination of pipettes of 0.8 ml and 0.4 ml (intended for
use in cats ≤ 4 kg) to provide the recommended dose (the minimum
recommended dose is 0.1 ml product/kg bodyweight)
Flea treatment and prevention (Ctenocephalides felis):
One treatment prevents future flea infestation for 4 weeks. Existing pupae in the
environment may emerge for 6 weeks or longer after treatment is initiated, depending
upon climatic conditions. Therefore, it may be necessary to combine treatment with
this veterinary medicinal product with environmental treatments aimed at breaking
the flea life cycle in the surroundings. This can result in a more rapid reduction in the
household flea population. The product should be administered at monthly intervals
when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of ear mite infestation (Otodectes cynotis):
A single dose of the product should be administered. A further veterinary examination
30 days after treatment is recommended as some animals may require a second
treatment. Do not apply directly to the ear canal.

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Treatment of notoedric mange (Notoedres cati
A single dose of the product should be administered.
Treatment of the lungworm Eucoleus aerophilus (syn. Capillaria aerophila) (adults):
A single dose of the product should be administered.
Prevention of :
The product should be administered monthly.
Treatment of Aelurostrongylus abstrusus:
The product should be administered monthly for three consecutive months.
Treatment of the eye worm Thelazia callipaeda (adults):
A single dose of the product should be administered.
Heartworm prevention (Dirofilaria immitis):
Cats in areas endemic for heartworm, or those which have travelled to endemic
areas, may be infected with adult heartworms. Therefore prior to treatment with the
product, the advice provided in section 4.5 should be considered.
For prevention of heartworm disease, the product must be applied at regular monthly
intervals during the time of the year when mosquitoes (the intermediate hosts which
carry and transmit heartworm larvae) are present. The product may be administered
throughout the year or at least 1 month before the first expected exposure to
mosquitoes. Treatment should continue at regular monthly intervals until 1 month
after the last exposure to mosquitoes. To establish a treatment routine, it is
recommended that the same day or date be used each month. When replacing
another heartworm preventative product in a heartworm prevention programme, the
first treatment with the product must be given within 1 month of the last dose of the
former medication.
In non-endemic areas there should be no risk of cats having heartworm. Therefore
they can be treated without special precautions.
Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme):
In areas endemic for heartworm, monthly treatment may significantly reduce the risk
of re-infection caused by the respective roundworms and hookworms. In areas non-
endemic for heartworm, the product can be used as part of a seasonal preve

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