Ridamax 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 veterinary medicinal product.
Unnecessary use of antiparasitics or use deviating from the instructions given in the
SPC may increase the resistance selection pressure and lead to reduced efficacy.
The decision to use the product should be based on confirmation of the parasitic
species and burden, or of the risk of infection/infestation based on its epidemiological
features, for each individual animal.
The use of the veterinary medicinal 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.

Issued: April 2024
AN: 01892/2022
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 veterinary medicinal product in sick and
debilitated animals, thus the veterinary medicinal product should only be used based
on a risk-benefit 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 veterinary medicinal product is not ingested by animals
and does not come into contact with the eyes or mouth of the recipient and/or other
animals.
Consider carefully the correct application method described in section 4.9, especially
that the veterinary medicinal product should be applied to the site specified in order
to minimise the risk for the animal to lick the veterinary medicinal product.
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.
In case of accidental oral uptake, symptomatic treatment should be administered.
There is no known specific antidote. The use of activated charcoal may be beneficial.
When the veterinary medicinal 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.
This veterinary medicinal product contains moxidectin (a macrocyclic lactone),
therefore special care should be taken with Collies, Old English Sheepdogs and related
breeds or crossbreeds, to correctly administer the veterinary medicinal product as
described under section 4.9; in particular, oral uptake by Collie or Old English Sheep
dogs and related breeds or crossbreeds should be prevented.
The veterinary medicinal 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 safety of an alternative veterinary medicinal product (of equivalent composition)
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 of the veterinary medicinal product 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 an alternative veterinary
medicinal product (of equivalent composition) may be safely administered to dogs
infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria
immitis. It is therefore recommended that all dogs 6 months of age or more, living in

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areas endemic for heartworm, should be tested for existing adult heartworm infection
before being treated with the veterinary medicinal product. At the discretion of the
veterinarian, infected dogs should be treated with an adulticide to remove adult
heartworms. The safety of the veterinary medicinal product 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
People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin
should administer this product with caution. In very rare cases the veterinary
medicinal product may cause skin sensitisation or transient skin reactions (for
example numbness, irritation, or burning/tingling sensation).
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.
In very rare cases this product may cause respiratory irritation in sensitive individuals.
Avoid contact with skin, eyes, or mouth.
Do not eat, drink, or smoke during application.
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.
If the product accidentally gets into eyes, they should be thoroughly flushed with
water.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical
advice immediately and show the package leaflet or label to the physician.
Special precautions for the protection of the environment
Treated dogs should not be allowed to enter surface water for 48 hours after
treatment to avoid adverse effects on aquatic organisms.
Other precautions
The solvent in this 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)
Dogs
Rare (1 to 10 animals / 10,000 animals
treated):
VomitingVery rare
(<1 animal / 10,000 animals treated,
including
isolated reports):
Application site itching
, Application site
hair loss
, Application site greasy fur
,
Application site eythema
Neurological signs
Lethargy
, Inappetence
Agitation
‘Undetermined frequency (cannot be
estimated from the available data):
Pruritus
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These signs are transient and disappear without further treatment.
These signs are mostly transient and can occur if the animal licks the application site
after treatment.
Transient.
Heartworm positive dogs with microfilaraemia:
Common (1 to 10 animals / 100 animals
treated):
Respiratory tract disorders (Cough,
Tachypnoea, Dyspnoea)
Digestive tract disorders (Vomiting,
Diarrhoea) Inappetence
Lethargy
May require prompt veterinary treatment.
The veterinary medicinal 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.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also section 16 of the
package leaflet for contact details.
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 the veterinary medicinal product no other antiparasitic
macrocyclic lactone should be administered.
No interactions are expected between the veterinary medicinal product and routinely
used veterinary medicinal products or medical or surgical procedures.
Safety of the veterinary medicinal product when administered on the same day as an
adulticide to remove adult heartworms has not been evaluated.
4.9 Amount(s) 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/kg bodyweight of the veterinary
medicinal product.
Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as
possible. For infestations/infections with the indicated parasites, the need for and

Issued: April 2024
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frequency of re-treatment(s) should be based on professional advice and should take
into account the local epidemiological situation and the animal’s lifestyle.
Weight of
dog [kg]
Pipette size to be usedVolume
[ml]
Imidacloprid
[mg/kg bw]
Moxidectin
[mg/kg bw]
> 10–25 kgRidamax for large dogs2.510–252.5–