NexGard Spectra / NexGard Spectra
Name of the veterinary medicinal product
Nexgard Spectra 9 mg/2 mg chewable tablets for dogs 2-3.5 kg
Nexgard Spectra 19 mg/4 mg chewable tablets for dogs >3.5-7.5 kg
Nexgard Spectra 38 mg/8 mg chewable tablets for dogs >7.5-15 kg
Nexgard Spectra 75 mg/15 mg chewable tablets for dogs >15-30 kg
Nexgard Spectra 150 mg/30 mg chewable tablets for dogs >30-60 kg
Afloxolaner, milbemycin oxime
Trade license holder: "Merial" 29, avenue Tony Garnier 69007 Lyon - France
Manufacturer responsible for launching the batch: Merial 4, Chemie du Calquet, 31000 Toulouse - France
Active substance (substances) and other ingredient (ingredients)
Each chewable tablet contains active substances:
| Nexgard Spectra | Afoxolaner (mg) | Milbemycin Oxime (mg) |
| Chewable tablets for dogs 2-3.5 kg | 9.375 | 1.875 |
| Chewable tablets for dogs >3.5-7.5 kg | 18.75 | 3.75 |
| Chewable tablets for dogs >7.5-15 kg | 37.50 | 7.50 |
| Chewable tablets for dogs >15-30 kg | 75.00 | 15.00 |
| Chewable tablets for dogs >30-60 kg | 150.00 | 30.00 |
Red-reddish brown in color, round (tablets for dogs 2-3.5 kg) or rectangular (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg for dogs).
Indications:
For the treatment of flea and tick infestations in dogs when the simultaneous prevention of heartworm disease and/or treatment of gastrointestinal worm infestations is indicated.
Treatment of flea infestations (Ctenocephalides felis and C.canis) in dogs.
Treatment of tick infestations (Dermacentor reticulates, Ixodes ricinus, Rhipicephalus sanguineus) in dogs.
Fleas and ticks must attach to the host and begin feeding in order to be exposed to the active substance.
Treatment of the following species of adult gastrointestinal worms: roundworm (Toxocara canis and Toxascaris leonina), stomach worm (Ancylostoma caninum and Ancylostoma brazilense) and intestinal worm (Trichuris vulpis).
Heartworm Dirofilaria immitis larvae disease prevention by monthly intake.
Contraindications:
Do not use in case of hypersensitivity to the active substance or any of the excipients.
Adverse reactions:
In clinical trials, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. The following adverse reactions have been reported infrequently: vomiting, diarrhea, lack of energy, loss of appetite, and itching. These events were generally self-limiting and of short duration.
The frequency of adverse reactions is determined as follows:
Very common (adverse reaction(s) occurred in more than 1 in 10 animals during treatment)
Common (more than 1 in 100, but less than 10)
Uncommon (more than 1 in 1,000 but less than 10)
Rare (more than 1 in 10,000 but less than 10)
Very rare (less than 1 in 10,000 animals, including isolated cases).
If you notice any serious or other side effects not listed in this leaflet, tell your vet
Target species:
dogs.
Dosage for each species, administration method:
Used only orally.
Dosage: The veterinary medicinal product is taken according to the following table:
| Dog body weight (kg) | Acceptable tablet quantity and potency | ||||
| Nexgard Spectra 9mg/2mg | Nexgard Spectra19 mg/4 mg | Nexgard Spectra 38mg/8mg | Nexgard Spectra75 mg/15 mg | Nexgard Spectra150mg/30mg | |
| 2-3.5 | 1 | ||||
| >3.5-7.5 | 1 | ||||
| >7.5-15 | 1 | ||||
| >15-30 | 1 | ||||
| >30-60 | 1 | ||||
Acceptance rule
Tablets are chewable and palatable to most dogs. If the dog does not take the tablet directly, it can be given with food.
Treatment mode:
The treatment scheme should be based on the veterinarian's diagnosis and the local epidemiological situation.
Nexgard Spectra is used as part of a seasonal flea and tick treatment (replacing an approved flea/tick product only) in dogs diagnosed with gastrointestinal worm infestations.
A single treatment is effective for gastrointestinal worms.
The effectiveness of the treatment against flea and tick infestations lasts for one month. Subsequent treatments may be indicated throughout the flea and/or tick season.
Ask your veterinarian how to proceed with flea and tick treatment.
Heartworm:
Nexgard Spectra kills Dirofilaria immitis larvae (heartworm) up to one month after they are transmitted by mosquitoes. Therefore, the product should be applied regularly at monthly intervals during the period of the year when mosquitoes are present. Treatment begins within the first month of the first expected exposure.
Treatment should be continued for up to 1 month after the last exposure to mosquitoes. It is recommended to choose the same day or date every month to stick to the treatment schedule. When switching to another heartworm preventive product, Nexgard Spectra should be started on the same day as the previous drug.
Dogs that live in or are exposed to heartworm-endemic environments may develop adult heartworms. The therapeutic effect against Dirofilaria immitis has not been established. Therefore, it is recommended that all dogs 8 months of age or older living in heartworm endemic areas be tested for adult heartworm infestation before starting treatment with this product for heartworm prevention.
Advice on proper administration of the drug:
Tablets are chewable and enjoyable for most dogs. If the dog does not take the tablet directly, it can be mixed with food.
Withdrawal period:
does not match
Special storage conditions:
Keep out of the reach of children.
Keep the blister in the outer carton in order to protect from light.
Do not use this veterinary product after the expiry date which is stated on the carton after EXP.
Special warnings:
Special warnings for each species:
Fleas and ticks must start feeding on the host to expose them to the substance afoxolaner; Therefore, the risk of disease transmission by fleas and ticks is not excluded.
Parasite resistance to any particular class of parasiticides can develop after frequent repeated use of that class of product. Therefore, the use of this product should be adapted to each individual case based on local information on disease status, including the current susceptibility of the target parasite to the active substance of this product, in order to limit the possibility of selection for resistance in the future.
Prevention of heartworm disease is critical. To reduce the risk of resistant celiac disease, it is recommended to check dogs for both circulating antigens and blood microfilariae at the beginning of each preventive treatment season. Only animals with negative results should be treated.
Special precautions for use in animals:
In the absence of data, treatment of puppies under 8 weeks of age and dogs weighing less than 2 kg should be based on a benefit-risk assessment by the responsible veterinarian.
In areas where heartworm disease is present, it is necessary to check dogs for heartworm infestation before starting the use of Nexgard Spectra. At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms. Nexgard Spectra has not been shown to eliminate microfilariae in dogs with positive results.
It is necessary to strictly follow the recommended doses in sheep or related species.
Special Precautions for Persons Administering Veterinary Medicines to Animals:
This product may cause gastrointestinal upset when taken internally.
Before use, the tablets should be kept in the blister packs, and the blisters in the outer carton.
In case of accidental ingestion, especially by children, seek medical attention immediately and show the package leaflet or label to the doctor.
It is necessary to wash hands after use
Laboratory studies in rats and rabbits did not show birth defects or any adverse effects on reproductive potential in males or females.
The safety of the veterinary medicinal product during pregnancy and lactation or in sexually mature dogs has not been established. To be used only according to benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction:
Milbemycin oxime is a P-glycoprotein (P-gp) substrate and, therefore, may interact with other P-gp substrates (eg digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates may result in increased toxicity.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions were observed in healthy eight-week-old puppies after 6 treatments at doses 5 times the maximum.
Special Precautions for Use of Unused Product or Waste Material
Ask your veterinarian how to dispose of medications you no longer need. The mentioned measures will help to protect the environment.
Date of last approval of insert sheet:
01/2015
Detailed information about this product can be obtained on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Other information:
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family. Active against adult fleas, as well as some ticks such as: Rhipicephalus sanguineus, Dermacentor reticulates and D.variabilis, lxodes ricinus and l.scapularis, Amblyomma americanum and Haemaphysalis longicomis.
Afoxolaner kills fleas before they lay eggs and therefore prevents the risk of infecting the family. Can be used as part of a flea allergy dermatitis control treatment strategy.
Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones.
Active against some gastrointestinal worms (such as: Toxacara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Trichuris vulpis) and Dirofilaria immitis larvae.
The following pack sizes of chewable tablets are available for each potency:
Box with 1 thermoformed blister containing 1, 3 or 6 chewable tablets.
Not all pack sizes are available in the market.
