NexGard Combo Cat

COMPOSITION: Esafoxolaner, eprinomectin, praziquantel
Each spot-on applicator contains: Active substances:

Excipients: Butylated hydroxytoluene (E321) 1mg/ml.

Spot-on solution.

Clear, colourless to light yellow to light brown solution.

INDICATIONS:
For cats infected or at risk of being infected with cestodes, nematodes and ectoparasites. The veterinary medicinal product is indicated only when all three groups are targeted at the same time.
Ectoparasites

• Treatment of flea infestations (Ctenocephalides felis). One treatment provides immediate and persistent flea killing activity for one month.
• The product may be part of a treatment strategy for the control of flea allergy dermatitis (FAD).
• Treatment of tick infestations. One treatment provides immediate and persistent tick killing activity against Ixodes scapularis for one month and against Ixodes ricinus for five weeks.
• Treatment of ear mites (Otodectes cynotis).
• Treatment of notoedric mange (caused by Notoedres cati).

Cestodes

• Treatment of infections with flatworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei and Joyeuxiella fuhrmanni).

Nematodes

• Prevention of heartworm disease (Dirofilaria immitis) for one month.
• Treatment of infections with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and Ancyclostoma ceylanicum and adults of Toxascaris leonina and Ancyclostoma braziliense).
• Treatment of infections with feline lungworms (L4 larvae and adults of Troglostrongylus brevior), L3, L4 larvae and adults of Aelurostrongylus abstrusus).
• Prevention of aelurostrongylosis (by reducing the level of infection with L3, L4 larvae of Aelurostrongylus abstrusus).
• Treatment of infections with bladder worms (Capillaria plica).

CONTRAINDICATIONS: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS:

In clinical studies, hypersalivation, diarrhea, transient skin reactions at the application site (local alopecia, pruritus), anorexia, lethargy and emesis were observed less frequently shortly after administration. Most of these reactions are mild, short-lived and self-limited.

The frequency of adverse reactions is defined using the following convention:

- Very common (more than 1 in 10 animals treated displaying adverse reactions)

- 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).

If you notice any adverse reactions, even those not already listed in this leaflet, or you think that the medicinal product has had no effect, please inform your veterinary surgeon.

TARGET SPECIES:

Cats.
METHOD OF ADMINISTRATION:

For topical application to the skin (spot-on administration).

Dosage

The minimum recommended doses are 1.44 mg esafoxolaner, 0.48 10 mg eprinomectin and 10 mg praziquantel per kg body weight.

RECOMMENDATIONS FOR CORRECT ADMINISTRATION:
Use the appropriate size applicator for your cat's weight (0.3 or 0.9 ml, see section “Statement of active substance(s) and other ingredients”)

1. Use scissors to cut the blister along the dotted line.
2. Then peel off the foil.
3. Remove the applicator from the packaging and hold it with the tip pointing upwards. Pull the plunger back slowly.
4. Twist and remove the cap.
5. Make a path through the fur in the middle of the neck, between the base of the skull and the shoulder blades so that the skin is visible. Position the tip of the applicator on the skin and apply the entire content directly to the skin in one spot. The product should be applied to dry skin in an area where the cat cannot lick it. In long-haired breeds, special care should be taken to apply the product directly to the skin and not to the fur to ensure optimal efficacy.
6. Wash hands after use.

Treatment regimen:
For the treatment of flea and/or tick and/or mange infestations and the concomitant treatment of gastrointestinal and/or lungworms and/or bladder and cestode nematodes, a single dose of the product should be applied. The need and frequency of treatment(s) should be in accordance with the advice of the veterinarian and take into account the local epidemiological situation and the animal's lifestyle (e.g. whether it has access to the outdoors).
See also the “special warnings” section.
Areas not endemic for feline cardiopulmonary nematodes:
Cats not at constant risk of infection with heartworm or feline lungworm should be treated according to a schedule prescribed by the veterinarian, adapted to each individual case of reinfection/infestation with parasites. Otherwise, a product with a narrower spectrum of activity that provides adequate treatment against the relevant parasites should be used.
Endemic areas with cardiovascular dirofilariosis:
Cats living in areas endemic for cardiovascular dirofilariosis and recognised as hunters can be treated at monthly intervals to ensure adequate prevention against cardiovascular dirofilariosis and treatment of possible re-infection with cestodes. Otherwise, a product with a narrower spectrum of activity should be used for continued treatment. Prevention of cardiovascular dirofilariosis by killing larvae of Dirofilaria immitis should be started within one month after the first exposure to mosquitoes and continued until 1 month after the last exposure to mosquitoes.
Endemic areas with feline lungworm:
At-risk (hunting) cats living in endemic areas can be treated at monthly intervals to reduce the risk of infestation with adult lungworms, responsible for clinical aelurostrongylosis, and to treat potential reinfections with tapeworms. Otherwise, a product with a narrower spectrum of activity should be used for subsequent treatment.
Lungworm treatment Due to the transit time of the L1 larva from the lungs to the digestive tract, no or little effect on the release of L1 larvae of A. Abstrusus in the faeces can be expected for approximately two weeks after treatment. For this reason, any count of larvae in the faeces to monitor the effectiveness of the treatment (and the decision on the need to use an antiparasitic with a narrower spectrum of activity for a second treatment) should be made at the earliest 2 weeks after treatment).
Ear mites
In the case of ear mites, request a re-examination by your veterinarian 4 weeks after treatment to decide whether additional treatment with a product with a narrower spectrum of action is necessary.

WITHDRAWAL TIME:
Not applicable.

SPECIAL STORAGE PRECAUTIONS:
Keep out of the sight and reach of children.
Keep unused applicator in the original package in order to protect from light. Opened applicators should be discarded immediately.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
SPECIAL WARNINGS:
Special precautions for the target species:
When applying the product, special attention should be paid to long-haired breeds to ensure that the product is applied directly to the skin and not to the fur, otherwise the active substance will have a reduced bioavailability.
Avoid shampooing the animal for 2 days after administration as the efficacy of the product in this case has not been tested.
Ticks and fleas must start feeding on the cat to be exposed to asafoxolaner, therefore the risk of transmitting an arthropod disease cannot be excluded.
Cats living in areas endemic for cardiovascular dirofilariasis or those that have travelled to such areas may be infected with adult heartworms. Although the product can be safely administered to cats infected with adult heartworms, no therapeutic effect against adult heartworms Dirofilaria immitis has been established. Therefore, it is recommended that all cats aged 6 months or older living in areas endemic for cardiovascular heartworm disease be tested for adult heartworm infection before being treated with the product for the prevention of cardiovascular heartworm disease.
Flatworm infection may recur if intermediate hosts such as fleas, mice, etc. are not controlled. Some cats in the patent period of Joyeuxiella spp. or Dipylidium caninum infection may, however, have high proportions of young forms of parasites that may be less sensitive to this product; therefore, post-treatment monitoring is recommended for these infections.
Parasite resistance to a particular class of antiparasitics included in the established combination of a product may develop as a result of repeated use of an antiparasitic from those classes over an extended period of time. Therefore, epidemiological information on the current susceptibility of the target species should be taken into account to limit the possibility of future selection for resistance.
In order to reduce re-infestations with the appearance of new fleas, it is recommended that all cats in the household are treated. Any other species of animals living in the same house should be treated with a product intended for them.
Fleas in any of their stages of development can infest a cat's basket, its bedding and its usual resting areas, such as carpets and soft furnishings. In the case of major infestations and before implementing control measures, these areas should be treated with an appropriate product and vacuumed regularly.
Special precautions for use in animals
For spot-on application only. Do not inject, administer orally or by any other route of administration. Avoid contact with the cat's eyes. In case of accidental eye exposure, rinse the eye area immediately with clean water. If eye irritation persists, seek veterinary advice.
It is very important that the veterinary medicinal product is applied to the skin in an area where the cat cannot lick the product, in the mid-neck area, between the base of the skull and the shoulder blades.
Ensure that the animals do not lick each other until the treated area is no longer visible. Oral ingestion of the veterinary medicinal product has been observed to cause hypersalivation in cats.
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 only be used against confirmed mixed infections or when cats are at significant risk of such mixed infections with ectoparasites and nematodes (including for the prevention of cardiovascular dirofilariasis) and when concomitant treatment against cestodes is indicated. In the absence of risk of co-infestation, an antiparasitic with a narrower spectrum of activity should be used as first-line treatment.
The reason for prescribing and the frequency of use of this product should take into account the individual needs of the cat based on clinical assessment, the animal’s lifestyle and the epidemiological situation (including the zoonotic risk, if relevant) so that the decision to use it is made only in situations of infection or risk of mixed infection.
The veterinary medicinal product should not be used in other cats without prior veterinary advice.
Repeated treatments should be limited to specific individual situations (see treatment application recommendations in the section “Recommendations on correct administration”) with a minimum interval between treatments of 4 weeks. Safety has not been evaluated beyond 6 months (see also sections “Special precautions for the target species” and “Overdose”), therefore a maximum of 6 consecutive months of treatment within a 12-month period is recommended.
Echinococcosis is a risk to humans and is one of the diseases monitored by the World Organisation for Animal Health (OIE). In the case of echinococcosis, specific rules for treatment and monitoring and protection of people should be followed. Experts or institutes in 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 when handling the product. Wash hands immediately after use.
Used applicators should be discarded immediately and kept out of the sight and reach of children.
Avoid contact of fingers with the contents of the applicator. If this happens, wash with soap and water. This veterinary medicinal product may cause eye irritation which, in exceptional cases, may be severe. In case of accidental contact with eyes, rinse immediately and thoroughly with water. Remove contact lenses, if present, within the first 5 minutes and continue rinsing. Seek medical advice and show the package leaflet or the label to the physician.
Make sure that the area to which the product has been applied is no longer visible before touching the application site. Children should not play with treated animals until the application site is no longer visible and it is recommended that recently treated animals do not sleep with their owners, especially children. It is recommended to treat animals in the evening to reduce contact with humans after treatment.
People with known hypersensitivity to esafoxolaner, eprinomectin or praziquantel or to any of the excipients should not handle this veterinary medicinal product.
Since fetotoxic and teratogenic effects have been described in laboratory animals following significant daily exposure to glycerol formal, pregnant women should wear gloves during administration to avoid direct contact with the product.
Pregnancy and lactation:
Can be used in breeding, in cats during pregnancy and lactation.
The safety of the veterinary medicinal product has not yet been established in male reproduction. Laboratory studies in rats and rabbits have not shown any evidence of adverse effects of the active substances on male reproductive capacity. In breeding males, use should only be based on the benefit/risk assessment of the veterinarian.
Overdose (symptoms, emergency procedures, antidotes):
Safety of use has been evaluated in healthy kittens aged 8 weeks or older who received a dose of up to 5 times the maximum recommended dose treated up to 6 times at 4-week intervals. At a dose of 3 times the maximum recommended dose, no adverse reactions were observed. At a dose 5 times the maximum recommended dose, a single severe neurological adverse reaction (ataxia, disorientation, apathy, tremor, hypothermia and pupil dilation) was observed after the third treatment and was reversible after washing the application site, emergency measures and symptomatic treatment. In some animals, at 5 times the maximum recommended dose, dark red subcutaneous areas were observed at the treatment site.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IN CASE
Medicines should not be disposed of via wastewater or household waste. Ask your veterinarian how to dispose of medicines no longer required. These measures help protect the environment. The product or an empty applicator should not enter water courses as this may be dangerous for fish and other aquatic organisms.
OTHER INFORMATION:
Esafoxolaner kills fleas before they lay eggs, thus preventing contamination of the house.