NexGard Combo
Authorised
This medicine is authorised for use in the European Union
esafoxolaner / eprinomectin / praziquantel
MedicineVeterinaryAuthorised
Overview
NexGard Combo is an antiparasitic veterinary medicine used to treat mixed infections with external parasites (fleas, ticks or mites) and internal parasites (tapeworm and roundworms) in cats.
The medicine should only be used in confirmed mixed infections or if cats are at significant risk of mixed infection with external parasites and roundworms and need treatment against tapeworm at the same time. If there is no risk of co-infestation, a narrower spectrum antiparasitic medicine should be considered.
For external parasites, an application of NexGard Combo can treat flea and tick infestation for one month. It can also be used to treat infestations with ear or skin mites and as part of the management of flea allergy dermatitis (an allergic skin reaction to flea bites).
For internal parasites, NexGard Combo can be used to treat infections with tapeworms and roundworms/hookworms in the gut as well as lungworms and a roundworm that infects the bladder. NexGard Combo can also be used to prevent heartworm disease for one month per application.
NexGard Combo contains the active substances esafoxolaner, eprinomectin and praziquantel.
NexGard Combo can only be obtained with a prescription. The medicine is available as a spot-on solution in applicators of two different volumes. The volume depends on the cat’s bodyweight. The content of the applicator is applied to the cat’s skin in a single spot in the middle of the neck where the cat cannot lick it off. Repeated treatments should be restricted to limited individual situations, with a minimum treatment interval of 4 weeks.
For more information about using NexGard Combo, see the package leaflet or contact your veterinarian or pharmacist.
The active substances in NexGard Combo act in different ways to kill external and internal parasites.
Esafoxolaner is an ectoparasiticide, which means that it kills external parasites that live on or in the skin, in the fur or in the ear of the cat. It interferes with the way signals pass between the parasite’s nerve cells (neurotransmission), resulting in uncontrolled activity of the parasite’s nervous system and death. Fleas and ticks are killed within 24 and 48 hours after treatment, respectively. Esafoxolaner kills fleas before egg production and therefore prevents household contamination.
Praziquantel and eprinomectin are endoparasiticides, which means they kill parasites that live inside the cat’s body. Praziquantel damages the cell membranes of tapeworms, leading to the death of the parasite. Eprinomectin interferes with nerve and muscle cells of roundworms, leading to the paralysis and death of the parasite.
The effectiveness of NexGard Combo was investigated in both laboratory and field studies.
Ectoparasites
In one field study in several EU countries, 557 cats with flea and/or tick infestations were given a single treatment with NexGard Combo or a comparator spot-on medicine containing different active substances (fipronil and (S)-methoprene). The study showed that NexGard Combo was effective in reducing the number of fleas in cats with flea infestations by at least 95% for up to 30 days after treatment; this treatment was at least as effective as the comparator product. No clear conclusion regarding the effectiveness of NexGard Combo against ticks could be drawn from this study, but adequate effectiveness of NexGard Combo against the tick species Ixodes ricinus was shown in dose-confirmation studies.
In another field study in 2 European countries, the effectiveness of a single dose of NexGard Combo was compared with placebo (a dummy treatment) against ear mites in 115 naturally infested cats. The study showed that NexGard Combo was effective in reducing the number of ear mites by at least 90%.
In a laboratory study with naturally and artificially infested cats, the efficacy of NexGard Combo against skin mites (notoedric mange) was compared to a placebo treatment at different time points. At each time point, the efficacy of NexGard Combo was 100%.
Endoparasites
In addition to a number of laboratory studies, a study on the effectiveness of the active substances eprinomectin and praziquantel was also already carried out with the authorised medicine Broadline. This study showed that the active substances are almost 100% effective against tapeworms and intestinal roundworms(Toxocara cati, Ancylostoma spp, Toxascaris leonina).
Echinococcosis caused by Echinococcus multilocularis tapeworms is a risk for humans and therefore medicines against these parasites must be 100% effective. Laboratory studies using artificially infected cats showed that NexGard Combo was effective at treating infections with E. multilocularis. Laboratory data previously submitted for Broadline (which also contains praziquantel, the active substance against this tapeworm) also showed 100% effectiveness.
Laboratory studies in artificially infected cats confirmed the effectiveness of NexGard Combo in preventing heartworm disease caused by Dirofilaria immitis for one month.
The effectiveness of NexGard Combo against different developmental stages of feline lungworm (Aelurostrongylus abstrusus) was demonstrated in a laboratory study. The effectiveness was further supported by studies previously carried out with the authorised medicine Broadline.
A study on the effectiveness of the active substances eprinomectin and praziquantel was previously carried out with the authorised medicine Broadline and showed that the active substances are more than 90% effective against another species of feline lungworm (Troglostrongylus brevior). Laboratory studies previously carried out with Broadline have also shown that the active substances are 100% effective against vesical roundworms (Capillaria plica) that affect the bladder.
The most frequent side effects with NexGard Combo (which may affect between 1 and 10 animals in 1,000) are excessive salivation, diarrhoea, skin reactions at the application site (hair loss, itching), loss of appetite, lethargy and vomiting. These reactions occur shortly after application and are mostly mild, of short duration and self-limiting.
For the full list of side effects of NexGard Combo, see the package leaflet.
Safety information has been included in the summary of product characteristics and the package leaflet for NexGard Combo, including the precautions to be followed by healthcare professionals and animal owners or keepers.
People who are hypersensitive (allergic) to esafoxolaner, eprinomectin or praziquantel should avoid contact with NexGard Combo.
The person who applies the medicine should not smoke, eat or drink during application and should avoid the medicine touching their fingers. They should wash their hands after handling the product.
People should not touch the animal at the site of application until the treated area is no longer noticeable. 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.
In case of skin or eye contact, immediately rinse the affected area with water and remove any contaminated clothes. Seek medical advice and show the package leaflet or the label to the physician.
People with known hypersensitivity to any of the ingredients should avoid contact with the product.
Pregnant women should wear gloves when applying the medicine to avoid direct contact with it.
The European Medicines Agency decided that NexGard Combo’s benefits are greater than its risks and it can be authorised for use in the EU.
NexGard Combo received a marketing authorisation valid throughout the EU on 06 January 2021.
Product information
Latest procedure affecting product information: II/0002/G
29/11/2021
Product details
- Name of medicine
- NexGard Combo
- Active substance
- eprinomectin
- esafoxolaner
- praziquantel
- International non-proprietary name (INN) or common name
- esafoxolaner
- eprinomectin
- praziquantel
- Species
- Cats
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP54AA54
Pharmacotherapeutic group
- Eprinomectin, combinations
- Avermectins
- Antiparasitic products, insecticides and repellents
Therapeutic indication
For cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.
News on NexGard Combo
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