Imidamox 400 mg/100 mg Spot-on Solution for Extra-Large Dogs

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). Efficacy against adult Dirofilaria repens has not been tested
under field conditions.
4.5 Special precautions for use
Special precautions for use in animals
The treatment of animals weighing less than 1 kg should be based on a benefit-risk
assessment.
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.
Care should be taken that the contents 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. When the product is applied

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in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent
the animal licking the application sites.
The product should only be applied to undamaged skin.
This product contains moxidectin (a macrocyclic lactone), therefore special care
should be taken with Collie or Old English Sheep dogs and related breeds or
crossbreeds, to correctly administer the product as described under section 4.9; in
particular, oral uptake by the recipient and/or other animals in close contact should
be prevented.
The safety of the product has only been evaluated in dogs classified as either Class
1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field
study. Therefore the use in dogs with obvious or severe symptoms of the disease
should be based on a careful benefit-risk assessment by the treating veterinarian.
Although experimental overdosage studies have shown that the product may be
safely administered to dogs infected with adult heartworms, it has no therapeutic
effect against adult . It is therefore recommended that all dogs 6
months of age or more, living in areas endemic for heartworm, should be tested for
existing adult heartworm infection before being treated with the product. At the
discretion of the veterinarian, infected dogs should be treated with an adulticide to
remove adult heartworms. The safety of the combination of imidacloprid and
moxidectin has not been evaluated when administered on the same day as an
adulticide.
Imidacloprid is toxic for birds, especially canaries.
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.

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Other precautions
The product should not enter water courses as it has harmful effects on aquatic
organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be
allowed to swim in surface waters for 4 days after treatment.
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 dogs. On rare occasions greasy
hair, 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 sites.
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.
A field study has shown that in heartworm positive dogs with microfilaraemia there is
a risk of severe respiratory signs (coughing, tachypnea and dyspnea) that may
require prompt veterinary treatment. In the study these reactions were common (seen
in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence)
and lethargy are also common adverse reactions following treatment in such dogs.
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).
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 product no other antiparasitic macrocyclic lactone should
be administered. No interactions between imidacloprid/moxidectin combination and

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routinely used veterinary medicinal products or medical or surgical procedures have
been observed. Safety of the product when administered on the same day as an
adulticide to remove adult heartworms has not been evaluated.
4.9 Amounts to be administered and administration route
For external use only (spot-on use).
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5
mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight.
The treatment schedule should be based on individual veterinary diagnosis and on
the local epidemiological situation.
Administer in accordance with the following table:
Dogs
[kg]
Pipette size to be used
Volume
[ml]
Imidacloprid
[mg/kg b.w.]
Moxidectin
[mg/kg b.w.]
>25-
imidacloprid/moxidectin 400
mg/100 mg spot-on solution for
extra-large dogs
410-162.5-4
>40
the appropriate combination of pipettes 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
the 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 biting lice (Trichodectes canis)
A single dose should be administered. A further veterinary examination 30 days after
treatment is recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis)
A single dose of the product should be administered. Loose debris should be gently
removed from the external ear canal at each treatment. 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.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)
A single dose should be administered twice 4 weeks apart.
Prevention of heartworm disease (D. immitis) and cutaneous dirofilariosis (skinworm)
(D. repens)
Dogs in areas endemic for heartworm, or those which

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