Endectrid 250 mg + 62.5 mg Spot-on Solution for 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

Revised: December 2025
MA split from NI Expiry following AN: 02103/2025
4.5 Special precautions for use
i) 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.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the product is not ingested by animals and does not come
into contact with the mouth of the recipient and/or other animals.
Consider carefully the correct application method described in section 4.9, especially
that the product should be applied at the base of the skull in order to minimise the risk
for the animal to lick the product. When the product is applied in 3 to 4 separate spots
(see section 4.9), specific care should be taken to prevent the animal licking the
application sites.
Do not allow recently treated animals to groom each other. Do not allow treated
animals to come into contact with untreated animals until the application site is dry.
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 this product has not been evaluated when administered on
the same day as an adulticide.
Imidacloprid is toxic for birds, especially canaries.
ii) Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.

Revised: December 2025
MA split from NI Expiry following AN: 02103/2025
In order to prevent children getting access to pipettes, keep the pipette in the original
packaging until ready for use and dispose of used pipettes immediately.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry. This
may be ensured by treating animals in the evening. Do not allow recently treated
animals to sleep with owners, especially children.
In case of accidental spillage onto skin, wash off immediately with soap and water.
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.
If skin or eye symptoms persist or if the product is accidentally swallowed, seek medical
advice immediately and show the package leaflet or label to the physician.
iii) 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)
Vomiting can occur on rare occasions. Use of the product may result in transient
pruritus in dogs. Transient local skin sensitivity reactions including increased itching,
hair loss, greasy fur and redness at application site have been reported in very rare
cases. These signs disappear without further treatment. Neurological signs such as
ataxia and muscle tremor (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))

Revised: December 2025
MA split from NI Expiry following AN: 02103/2025
- 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 in the target species. Therefore, the use of the product is not
recommended in animals intended for breeding or during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
During treatment with this veterinary medicinal product no other antiparasitic
macrocyclic lactone should be administered.
No interactions between this veterinary medicinal product and routinely used veterinary
medicinal products or medical or surgical procedures have been observed.
Safety of this veterinary medicinal 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
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5
mg/kg bodyweight moxidectin, equivalent to 0.1 ml of this product per kg bodyweight.
The treatment schedule should be based on individual veterinary diagnosis and on the
local epidemiological situation.
Weight of dog
[kg]
Pipette size to be usedVolume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
> 10–25 kgEndectrid for large dogs2.510–252.5–