Nexgard Spectra - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

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

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France SCS,

4 Chemin du Calquet,

31000 Toulouse,

FRANCE

• 2. 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 Afoxolaner, milbemycin oxime

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each chewable tablet contains the 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

Mottled red to reddish brown, circular shaped (tablets for dogs 2–3.5 kg) or rectangular shaped (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).

• 4. INDICATION(S)

For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum ), thelaziosis (adult Thelazia callipaeda ) 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 reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus ) in dogs.

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina ), hookworms (Ancylostoma caninum , Ancylostoma braziliense and Ancylostoma ceylanicum ) and whipworm (Trichuris vulpis ).

Treatment of demodicosis (caused by Demodex canis ).

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

Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.

Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum ) with monthly administration.

Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.

• 5. CONTRAINDI­CATIONS

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

• 6. ADVERSE REACTIONS

Clinical studies

Vomiting, diarrhoea, lack of energy, decreased appetite and itching were uncommonly observed.

These occurrences were generally self-limiting and of short duration.

Post-marketing safety experience

Erythema and neurological signs (convulsions, ataxia and muscle tremors) 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 reaction(s)

• – 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 side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For oral use.

Dose:

The veterinary medicinal product should be administered in accordance with the following table:

Bodyweight (kg) of dog	Number and strength of tablet to be administered
	NEXGARD SPECTRA 9 mg/ 2 mg	NEXGARD SPECTRA 19 mg/ 4 mg	NEXGARD SPECTRA 38 mg/ 8 mg	NEXGARD SPECTRA 75 mg/ 15 mg	NEXGARD SPECTRA 150 mg/ 30 mg
2–3.5	1
>3.5–7.5		1
>7.5–15			1
>15–30				1
>30–60					1

For dogs above 60 kg appropriate combinations of chewable tablets should be used.

Method of administration:

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

Treatment schedule:

The treatment schedule should be based on veterinary diagnosis and on the local epidemiological situation.

Treatment of flea and tick infestations and gastrointestinal worms:

NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing a product authorised for the treatment of fleas/ticks only) in dogs with diagnosed concurrent gastrointestinal worm infestations.

A single treatment is effective for gastrointesti­nal worms.

Efficacy of the treatment against flea and tick infestations lasts for one month. Further treatments may be indicated throughout the flea and/or tick season. Ask your veterinarian how to continue flea and tick treatment.

Treatment of demodicosis (caused by Demodex canis ):

Monthly administration of the product until two negative skin scrapings are obtained one month apart. Severe cases may require prolonged monthly treatments. As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

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

Monthly administration of the product for two consecutive months. Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.

Prevention of heartworm disease:

NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes. Therefore, the product should be administered at regular monthly intervals during the time of the year when mosquitoes are present, starting in the month after the first expected exposure to them.

Treatment should continue until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered.

Dogs living in heartworm endemic areas (where heartworm disease is present), or those which have travelled to endemic areas, may be infested with adult heartworms. No therapeutic effect against adult Dirofilaria immitis has been established. It is therefore recommended that all dogs 8 months of age or more, living in heartworm endemic areas, should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.

Prevention of Angiostrongylosis:

In endemic areas, monthly administration of the product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs.

Prevention of thelaziosis:

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

• 9. ADVICE ON CORRECT ADMINISTRATION

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

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Keep the blister in the outer carton in order to protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.

Special warnings for each species:

Fleas and ticks need to start feeding on the host to become exposed to the substance afoxolaner; therefore the risk of the transmission of diseases by fleas and ticks cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in Southeast Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.

Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class. Therefore, the use of this product should be adapted to each individual case based on local information relating to disease status, including current susceptibility of the target parasites to the active substances in this product, in order to limit the possibility of a future selection for resistance.

Heartworm disease prevention is critical. To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment. Only negative animals should be treated.

Special precautions for use in animals:

In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.

In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA. At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms. NEXGARD SPECTRA is not indicated for removal of microfilariae from positive dogs.

The recommended dose should be strictly observed in collies or 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 tablets in the blister packs until required, and keep the blisters in the outer carton.

• – In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.

• – Wash hands after use.

Pregnancy and lactation :

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

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

Interaction with other medicinal products and other forms of interaction:

Milbemycin oxime is a substrate for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.

Overdose (symptoms, emergency procedures, antidotes):

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to

• 5 times the maximum dose.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION