NEXGARD SPECTRA

Nexgard Spectra is indicated for the treatment of flea and tick infestations in dogs when the prevention of heartworm, angiostrongylosis, thelaziosis and/or the treatment of gastrointestinal worm infestations is also indicated. It is extremely useful in the treatment of flea and tick infestations.

In the treatment of adult gastrointestinal nematode infestations of the following species: roundworms, hookworms and whipworms.

Nexgard Spectra can be used for: the treatment of canine demodicosis, the treatment of sarcoptic mange, the prevention of heartworm, the prevention of angiostrongylosis, the prevention of thelaziosis.

Each chewable tablet contains the following active ingredients:

Red to reddish brown marbled tablets, 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).

INDICATIONS:

For the treatment of flea and tick infestations in dogs when the prevention of heartworm disease (Dirofilaria immitis larval stage), angiostrongylosis (reduction of Angiostrongylus vasorum infestation in immature adult (L5) and adult stages), thelazia (Thelazia callipaeda adult) and/or the treatment of gastrointestinal worm infestations is also indicated.
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs.
Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs.
Fleas and ticks must be attached to the host and begin feeding to be exposed to the active substance.
Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxocara leonina), hookworms (Ancyclostoma caninum, Ancyclostoma braziliense and Ancyclostoma ceylanicum) and whipworms (Trichuris vulpis)
Treatment of canine demodicosis (caused by Demodex canis).
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Prevention of heartworm disease (Dirofilaria immitis larval stage) when administered monthly.
Prevention of angiostrongylosis (by reducing the level of Angiostrongylus vasorum infestation in the immature adult (L5) and adult stages) when administered monthly.
Prevention of the onset of thelaziasis (adult ocular infection with Thelazia callipaeda) if administered monthly.
CONTRAINDICATIONS

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

ADVERSE REACTIONS

Clinical studies

Vomiting, diarrhoea, lack of energy, decreased appetite and itching have been observed uncommonly. These reactions have generally resolved spontaneously and were of short duration.

Post-marketing safety experience

Erythema and neurological signs (convulsions, ataxia and muscle tremor) have been reported very rarely.

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.

METHOD OF ADMINISTRATION

For oral use.
Dosage:

The product should be administered according to the following table:

For dogs over 60 kg body weight, the required combination of chewable tablets will be used

Method of administration:

The tablets are chewable and palatable to most dogs. If the dog does not accept the tablets directly, they can be administered with food.

Treatment regimen:

The treatment regimen should be established according to the veterinarian's diagnosis and the local epidemiological situation.

Treatment of flea and tick infestations and gastrointestinal nematodes:

NEXGARD SPECTRA can be used as a seasonal treatment against fleas and ticks (replacing a product with activity only against fleas and ticks) in dogs concurrently infested with gastrointestinal worms.

A single treatment is effective against gastrointestinal worms.

The treatment against fleas and ticks remains effective for one month. Additional treatments may be necessary during the flea and/or tick season. Seek veterinary advice on how to continue this treatment.

Treatment of demodicosis (caused by Demodex canis):

Monthly administration of the product until at least 2 consecutive monthly skin scrapings are negative. Severe cases may require prolonged monthly treatments.

Since demodicosis is a disease caused by various factors, it is also recommended to treat all associated diseases appropriately, when possible.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):

Monthly administration of the product for 2 consecutive months. Subsequent monthly administration may be necessary based on clinical evaluation and skin scraping examination.

Prevention of heartworm disease:

NEXGARD SPECTRA kills larvae of Dirofilaria immitis (heartworm) for 1 month after their transmission by mosquitoes. Therefore, the product should be administered at regular monthly intervals throughout the mosquito breeding season, starting in the month following the first exposure to mosquitoes.

Treatment should be continued until the month following the last exposure to mosquitoes. In order to establish a treatment routine, it is recommended to administer the treatment on the same day of the month. When replacing another heartworm prevention product, the first treatment with NEXGARD SPECTRA should be started on the day the previous medication was due.

Dogs living in or having travelled to an area with heartworm disease may be infested with adult heartworms. No therapeutic effect has been established against adult Dirofilaria immitis. It is therefore recommended that all dogs aged 8 months or older living in heartworm endemic areas be tested for adult heartworm infestation before being treated with a heartworm prevention product.

Prevention of Angiostrongylosis:

In endemic areas, monthly administration of the product will reduce infestations with Angiostrongylus vasorum in the immature adult (L5) and adult stages in the heart and lungs.

Prevention of Thelazia:

Monthly administration of the product prevents the establishment of ocular infection with the adult form of Thelazia callipaeda.

RECOMMENDATIONS ON CORRECT ADMINISTRATION

The tablets are chewable and palatable to most dogs. If the dog does not accept the tablets directly, they can be administered with food.

Special precautions for use in animals:

In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs weighing less than 2 kg should only be carried out based on a benefit-risk assessment by the veterinarian.

Dogs living in areas where cardiovascular heartworm disease is present should be tested for adult heartworm infestation before administration of NEXGARD SPECTRA. Infested dogs should be treated with an adulticide of the veterinarian’s choice to eliminate adult heartworms. NEXGARD SPECTRA is not indicated for the elimination of microfilariae in dogs diagnosed as positive.

The recommended dosage should be strictly followed in the case of Collie dogs or other related breeds.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

- This product may cause gastrointestinal disturbances if ingested.

- Keep the tablets in blisters and the blister in the carton until use.

- In case of accidental ingestion, especially by children, seek medical advice immediately and show the label to the physician.

- Wash hands after use.

Pregnancy and lactation:

Laboratory studies in rats and rabbits have not shown any birth defects or any adverse effect on the reproductive capacity of males and females.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. Use according to the benefit-risk assessment of the veterinarian.

Interactions with other medicinal products and other forms of interaction:

Milbemycin oxime is a substrate of p-glycoprotein (P-gp) and may therefore interact with other P-gp substrates (e.g. digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates may lead to increased toxicity.

Overdose (symptoms, emergency procedures, antidotes):

No adverse reactions were observed in healthy chickens over 8 weeks of age after 6 treatments with 5 times the maximum dose.