NexGard Combo Spot-on Solution for Cats 2.5-7.5 kg

When applying the veterinary medicinal product, special attention should be paid to long
hair breeds in order to ensure that the product is applied directly to the skin and not on the
hair, as this could lead to a lower bioavailability of the active substance.
Ticks and fleas need to start feeding on the cat to become exposed to esafoxolaner;
therefore, the risk of transmission of arthropod borne diseases cannot be excluded.
Cats in endemic areas for heartworm, or those which have travelled to endemic areas,
may be infected with adult heartworms. Although the veterinary medicinal product may be
safely administered to cats infected with adult heartworms, no therapeutic effect against

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adult Dirofilaria immitis has been established. It is, therefore, recommended that all cats 6
months of age or older, living in endemic areas for heartworm, should be tested for
existing adult heartworm infection before being treated with the product for heartworm
disease prevention.
Tapeworm infection may reoccur unless control of intermediate hosts such as fleas, mice
etc. is undertaken. Some cats with patent Joyeuxiella spp. or Dipylidium caninum infection
may nevertheless harbour a high proportion of juvenile worms, which may be less
susceptible to the product; therefore, a post-treatment follow-up is recommended in case
of such infections.
In certain individual cats Notoedres cati infestation may be severe or complicated by
bacterial infections. In these severe cases concomitant treatment may be necessary.
Parasite resistance to any particular class of antiparasitics included in the fixed
combination product may develop following repeated use of antiparasitics of those classes
over an extended period of time. Therefore, epidemiological information about current
susceptibility of the target species should be taken into account in order to limit the
possibility of a future selection for resistance.
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 infestation based on its epidemiological features, for each individual animal.
In the absence of risk of co-infection, a narrow spectrum product should be used.
The possibility that other animals in the same household can be a source of re-infection
with fleas or worms should be considered, and these should be treated as necessary with
an appropriate product.
Avoid shampooing the animal within the 2 days following application because the
effectiveness of the product in this case has not been tested.
To reduce re-infestation from emergence of new fleas, it is recommended that all cats in a
household are treated. Other animal species living in the same household should also be
treated with a suitable product.
All stages of fleas can infest the cat’s basket, bedding and regular resting areas such as
carpets and soft furnishings. In case of massive flea infestation and at the beginning of the
control measures, these areas should be treated with a suitable environmental product
and then vacuumed regularly.

Special precautions for safe use in the target species:
Spot-on application only. Do not inject, do not administer orally or via any other route.
Avoid contact with the cat's eyes. If accidental ocular contact occurs, flush the eyes
immediately with clean water. If eye irritation persists, seek veterinary advice.

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It is important to apply the veterinary medicinal product to a skin area where the cat
cannot lick it off: on the midline of the neck, between the base of the skull and the
shoulder blades. Ensure that animals do not lick each other until the treated area is no
longer noticeable.
Oral ingestion of the veterinary medicinal product has been observed to lead to
hypersalivation.
The safety of the veterinary medicinal product has not been tested in kittens under 8
weeks of age. The product is for use in cats weighing at least 0.8 kg and from 8 weeks of
age.
The veterinary medicinal product should exclusively be used in confirmed mixed infections
or where cats are at significant risk of such mixed infection with ectoparasites and
nematodes (including for heartworm disease prevention) and where concurrent treatment
against cestodes is indicated. In the absence of risk of co-infestation, the use of a narrow
spectrum parasiticide should be considered as a first line therapy.
The rationale for prescription and frequency of use should be tailored to the individual
needs of the cat, based on clinical assessment, the animal’s lifestyle and on the local
epidemiological situation (including zoonotic risks, where relevant) in order to address
exclusively situations of mixed infections/risk of infection.
The veterinary medicinal product should not be used in other cats without prior veterinary
consultation.
Target animal safety has not been evaluated beyond 6 consecutive monthly treatments
and accumulation of esafoxolaner and eprinomectin was observed up to the 5th monthly
administration (see also sections 3.10 and 4.3). Repeated treatments beyond 6
consecutive months should be restricted to limited individual situations (see section 3.9 for
treatment guidance), with a minimum treatment interval of 4 weeks, according to a benefit-
risk evaluation by the responsible veterinarian.
Echinococcosis represents a hazard for humans and is a notifiable disease to the World
Organisation for Animal Health (WOAH). In case of echinococcosis, specific guidelines on
the treatment and follow up and on the safeguard of persons have to be followed. Experts
or institutes of parasitology should be consulted.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Do not smoke, drink or eat during application. Wash hands immediately after use.
Used applicators should be disposed of immediately and not left within the sight or reach
of children.
Avoid contact of the applicator content with the fingers. If this occurs, wash off with soap
and water. This veterinary medicinal product can cause eye irritation, which might be in
exceptional cases severe. In case of accidental eye exposure, flush the eyes immediately
and thoroughly with water. Remove contact lenses, if present, after the first 5 minutes, and
then continue rinsing. Seek medical advice and show the package leaflet or the label to
the physician.

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Ensure that the treated area is no longer noticeable before resuming contact with the site
of application. Children should not be allowed to play with treated animals until the
application site is no longer noticeable and it is recommended that recently treated
animals do not sleep with owners, especially children.
It is recommended to treat animals in the evening to reduce contact with people after
treatment.
People with a known hypersensitivity to esafoxolaner, eprinomectin or praziquantel or to
any of the excipients should avoid contact with the veterinary medicinal product.
Since foetotoxic and teratogenic effects are described in laboratory animals after
significant daily exposure to glycerol formal, pregnant women should wear gloves during
the administration to avoid direct contact with the product.
Special precautions for the protection of the environment:
Not applicable.