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NexGard Spectra

NexGard Spectra
2-3.5kg Extra Small Dog Chewable Tablet » Pack of 3
3.5-7.5kg Small Dog Chewable Tablet » Pack of 3
15-30kg Large Dog Chewable Tablet » Pack of 3
30-60kg Extra Large Dog Chewable Tablet » Pack of 3

  • 2-3.5kg Extra Small Dog Chewable Tablet » Pack of 3 £21.49
  • 3.5-7.5kg Small Dog Chewable Tablet » Pack of 3 £22.49
  • 7.5-15kg Medium Dog Chewable Tablet » Pack of 3 £25.49
  • 15-30kg Large Dog Chewable Tablet » Pack of 3 £29.99
  • 30-60kg Extra Large Dog Chewable Tablet » Pack of 3 £34.49

Selection of 5 products from

£21.49 to £34.49

Description

NexGard Spectra is supplied in the form of a chewable, beef-flavoured tablet to be given once per month to dogs. It controls fleas, ticks, heartworm and gastro-intestinal roundworms. This is a very wide range of major parasites to be controlled safely and effectively with simple once monthly dosing.

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Medication Datasheets

15-30kg Large Dog Chewable Tablet » Pack of 3

NexGard Spectra Chewable Tablets for Dogs

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see below.

Pharmaceutical form

Mottled red to reddish brown circular shaped (for dogs 2–3.5 kg) or rectangular shaped (for dogs >3.5–7.5 kg, >7.5–15 kg, >15–30 kg and >30‑60 kg) chewable tablets.

Clinical particulars

Target species

Dogs

Indications for use

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) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.

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).

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.

Contra-indications

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

Special warnings for each target species

Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in South-East 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 based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 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 heartworm endemic areas, 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 microfilariae clearance.

The recommended dose should be strictly observed in collies or related breeds.

Special precautions to be taken by the person administering the product to animals

Adverse reactions

In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. Adverse reactions such as vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. These occurrences were generally self-limiting and of short duration.

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).

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, 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.

Interactions 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.

Amounts to be administered and administration route

For oral use.

Dose: The product should be administered at a dose of 2.50–5.36 mg/kg bodyweight of afoxolaner and 0.50–1.07 mg/kg bodyweight of milbemycin oxime in accordance with the following table:

Weight (kg) Dosage
2 - 3.5 1 x NexGard Spectra (XS) 9 mg/2 mg tablet
> 3.5 - 7.5 1 x NexGard Spectra (S) 19 mg/4 mg tablet
>7.5 - 15 1 x NexGard Spectra (M) 38 mg/8 mg tablet
>15 - 30 1 x NexGard Spectra (L) 75 mg/15 mg tablet
>30 - 60 1 x NexGard Spectra (XL) 150 mg/30 mg tablet

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 nematodes:

NexGard Spectra can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.

Prevention of heartworm disease:

NexGard Spectra kills Dirofilaria immitis larvae 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 vectors are present, starting in the month after the first expected exposure to mosquitoes. 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, 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.

Overdose

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.

Pharmacological particulars

Pharmacodynamic properties

Afoxolaner:

Afoxolaner is an insecticide and acaricide of the isoxazoline family. Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA). Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors.

It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.

Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Milbemycin oxime:

Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. Milbemycin oxime contains two major factors, A3 and A4 (ratio of 20:80 for A3:A4). It is a fermentation product of Streptomyces milbemycinicus. Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates. Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell. This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.

Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).

Pharmaceutical particulars

Excipients

Maize starch, Soy protein, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides, Citric acid monohydrate (E330), Butyl-hydroxytoluene (E321).

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 2 years.

Special precautions for storage

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

Immediate packaging

The product is individually packaged in plastic blisters. One carton contains one blister of 1, 3 or 6 chewable tablets. Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Merial

29, avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/14/177/001-015

Legal category

7.5-15kg Medium Dog Chewable Tablet » Pack of 3

NexGard Spectra Chewable Tablets for Dogs

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see below.

Pharmaceutical form

Mottled red to reddish brown circular shaped (for dogs 2–3.5 kg) or rectangular shaped (for dogs >3.5–7.5 kg, >7.5–15 kg, >15–30 kg and >30‑60 kg) chewable tablets.

Clinical particulars

Target species

Dogs

Indications for use

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) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.

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).

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.

Contra-indications

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

Special warnings for each target species

Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in South-East 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 based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 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 heartworm endemic areas, 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 microfilariae clearance.

The recommended dose should be strictly observed in collies or related breeds.

Special precautions to be taken by the person administering the product to animals

Adverse reactions

In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. Adverse reactions such as vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. These occurrences were generally self-limiting and of short duration.

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).

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, 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.

Interactions 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.

Amounts to be administered and administration route

For oral use.

Dose: The product should be administered at a dose of 2.50–5.36 mg/kg bodyweight of afoxolaner and 0.50–1.07 mg/kg bodyweight of milbemycin oxime in accordance with the following table:

Weight (kg) Dosage
2 - 3.5 1 x NexGard Spectra (XS) 9 mg/2 mg tablet
> 3.5 - 7.5 1 x NexGard Spectra (S) 19 mg/4 mg tablet
>7.5 - 15 1 x NexGard Spectra (M) 38 mg/8 mg tablet
>15 - 30 1 x NexGard Spectra (L) 75 mg/15 mg tablet
>30 - 60 1 x NexGard Spectra (XL) 150 mg/30 mg tablet

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 nematodes:

NexGard Spectra can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.

Prevention of heartworm disease:

NexGard Spectra kills Dirofilaria immitis larvae 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 vectors are present, starting in the month after the first expected exposure to mosquitoes. 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, 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.

Overdose

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.

Pharmacological particulars

Pharmacodynamic properties

Afoxolaner:

Afoxolaner is an insecticide and acaricide of the isoxazoline family. Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA). Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors.

It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.

Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Milbemycin oxime:

Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. Milbemycin oxime contains two major factors, A3 and A4 (ratio of 20:80 for A3:A4). It is a fermentation product of Streptomyces milbemycinicus. Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates. Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell. This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.

Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).

Pharmaceutical particulars

Excipients

Maize starch, Soy protein, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides, Citric acid monohydrate (E330), Butyl-hydroxytoluene (E321).

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 2 years.

Special precautions for storage

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

Immediate packaging

The product is individually packaged in plastic blisters. One carton contains one blister of 1, 3 or 6 chewable tablets. Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Merial

29, avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/14/177/001-015

Legal category

3.5-7.5kg Small Dog Chewable Tablet » Pack of 3

NexGard Spectra Chewable Tablets for Dogs

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see Pharmaceutical particulars.

Pharmaceutical form

Mottled red to reddish brown circular shaped (for dogs 2–3.5 kg) or rectangular shaped (for dogs >3.5–7.5 kg, >7.5–15 kg, >15–30 kg and >30‑60 kg) chewable tablets.

Clinical particulars

Target species

Dogs

Indications for use

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) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.

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.

Contra-indications

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

Special warnings for each target species

Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in South-East 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 based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 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 heartworm endemic areas, 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 microfilariae clearance.

The recommended dose should be strictly observed in collies or related breeds.

Special precautions to be taken by the person administering the product to animals

Adverse reactions

In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. Adverse reactions such as vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. These occurrences were generally self-limiting and of short duration.

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).

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, 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.

Interactions 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.

Amounts to be administered and administration route

For oral use.

Dose: The product should be administered at a dose of 2.50–5.36 mg/kg bodyweight of afoxolaner and 0.50–1.07 mg/kg bodyweight of milbemycin oxime in accordance with the following table:

Weight (kg) Dosage
2 - 3.5 1 x NexGard Spectra (XS) 9 mg/2 mg tablet
> 3.5 - 7.5 1 x NexGard Spectra (S) 19 mg/4 mg tablet
>7.5 - 15 1 x NexGard Spectra (M) 38 mg/8 mg tablet
>15 - 30 1 x NexGard Spectra (L) 75 mg/15 mg tablet
>30 - 60 1 x NexGard Spectra (XL) 150 mg/30 mg tablet

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 nematodes:

NexGard Spectra can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.

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 administration of the product may be required based on clinical assessment and skin scrapings.

Prevention of heartworm disease:

NexGard Spectra kills Dirofilaria immitis larvae 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 vectors are present, starting in the month after the first expected exposure to mosquitoes. 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, 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.

Overdose

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.

Pharmacological particulars

Pharmacodynamic properties

Afoxolaner:

Afoxolaner is an insecticide and acaricide of the isoxazoline family. Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA). Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors.

It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.

Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Milbemycin oxime:

Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. Milbemycin oxime contains two major factors, A3 and A4 (ratio of 20:80 for A3:A4). It is a fermentation product of Streptomyces milbemycinicus. Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates. Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell. This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.

Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).

Pharmaceutical particulars

Excipients

Maize starch, Soy protein, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides, Citric acid monohydrate (E330), Butyl-hydroxytoluene (E321).

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 2 years.

Special precautions for storage

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

Immediate packaging

The product is individually packaged in plastic blisters. One carton contains one blister of 1, 3 or 6 chewable tablets. Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Merial

29, avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/14/177/001-015

Legal category

30-60kg Extra Large Dog Chewable Tablet » Pack of 3

NexGard Spectra Chewable Tablets for Dogs

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see Pharmaceutical particulars.

Pharmaceutical form

Mottled red to reddish brown circular shaped (for dogs 2–3.5 kg) or rectangular shaped (for dogs >3.5–7.5 kg, >7.5–15 kg, >15–30 kg and >30‑60 kg) chewable tablets.

Clinical particulars

Target species

Dogs

Indications for use

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) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.

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.

Contra-indications

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

Special warnings for each target species

Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in South-East 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 based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 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 heartworm endemic areas, 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 microfilariae clearance.

The recommended dose should be strictly observed in collies or related breeds.

Special precautions to be taken by the person administering the product to animals

Adverse reactions

In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. Adverse reactions such as vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. These occurrences were generally self-limiting and of short duration.

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).

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, 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.

Interactions 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.

Amounts to be administered and administration route

For oral use.

Dose: The product should be administered at a dose of 2.50–5.36 mg/kg bodyweight of afoxolaner and 0.50–1.07 mg/kg bodyweight of milbemycin oxime in accordance with the following table:

Weight (kg) Dosage
2 - 3.5 1 x NexGard Spectra (XS) 9 mg/2 mg tablet
> 3.5 - 7.5 1 x NexGard Spectra (S) 19 mg/4 mg tablet
>7.5 - 15 1 x NexGard Spectra (M) 38 mg/8 mg tablet
>15 - 30 1 x NexGard Spectra (L) 75 mg/15 mg tablet
>30 - 60 1 x NexGard Spectra (XL) 150 mg/30 mg tablet

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 nematodes:

NexGard Spectra can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.

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 administration of the product may be required based on clinical assessment and skin scrapings.

Prevention of heartworm disease:

NexGard Spectra kills Dirofilaria immitis larvae 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 vectors are present, starting in the month after the first expected exposure to mosquitoes. 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, 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.

Overdose

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.

Pharmacological particulars

Pharmacodynamic properties

Afoxolaner:

Afoxolaner is an insecticide and acaricide of the isoxazoline family. Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA). Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors.

It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.

Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Milbemycin oxime:

Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. Milbemycin oxime contains two major factors, A3 and A4 (ratio of 20:80 for A3:A4). It is a fermentation product of Streptomyces milbemycinicus. Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates. Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell. This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.

Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).

Pharmaceutical particulars

Excipients

Maize starch, Soy protein, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides, Citric acid monohydrate (E330), Butyl-hydroxytoluene (E321).

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 2 years.

Special precautions for storage

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

Immediate packaging

The product is individually packaged in plastic blisters. One carton contains one blister of 1, 3 or 6 chewable tablets. Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Merial

29, avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/14/177/001-015

Legal category

2-3.5kg Extra Small Dog Chewable Tablet » Pack of 3

NexGard Spectra Chewable Tablets for Dogs

Qualitative and quantitative composition

Active substance:

Each chewable tablet contains:

For the full list of excipients, see below.

Pharmaceutical form

Mottled red to reddish brown circular shaped (for dogs 2–3.5 kg) or rectangular shaped (for dogs >3.5–7.5 kg, >7.5–15 kg, >15–30 kg and >30‑60 kg) chewable tablets.

Clinical particulars

Target species

Dogs

Indications for use

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) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.

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).

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.

Contra-indications

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

Special warnings for each target species

Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.

Ancylostoma ceylanicum is reported as being endemic only in South-East 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 based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 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 heartworm endemic areas, 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 microfilariae clearance.

The recommended dose should be strictly observed in collies or related breeds.

Special precautions to be taken by the person administering the product to animals

Adverse reactions

In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner and milbemycin oxime. Adverse reactions such as vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. These occurrences were generally self-limiting and of short duration.

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).

Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, 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.

Interactions 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.

Amounts to be administered and administration route

For oral use.

Dose: The product should be administered at a dose of 2.50–5.36 mg/kg bodyweight of afoxolaner and 0.50–1.07 mg/kg bodyweight of milbemycin oxime in accordance with the following table:

Weight (kg) Dosage
2 - 3.5 1 x NexGard Spectra (XS) 9 mg/2 mg tablet
> 3.5 - 7.5 1 x NexGard Spectra (S) 19 mg/4 mg tablet
>7.5 - 15 1 x NexGard Spectra (M) 38 mg/8 mg tablet
>15 - 30 1 x NexGard Spectra (L) 75 mg/15 mg tablet
>30 - 60 1 x NexGard Spectra (XL) 150 mg/30 mg tablet

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 nematodes:

NexGard Spectra can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a monovalent flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infestations. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.

Prevention of heartworm disease:

NexGard Spectra kills Dirofilaria immitis larvae 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 vectors are present, starting in the month after the first expected exposure to mosquitoes. 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, 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.

Overdose

No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.

Pharmacological particulars

Pharmacodynamic properties

Afoxolaner:

Afoxolaner is an insecticide and acaricide of the isoxazoline family. Afoxolaner acts as an antagonist at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA). Isoxazolines, among the chloride channel modulators, bind to a distinct and unique target site within the insect GABACls, thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors.

It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.

Afoxolaner kills fleas before egg production and therefore prevents the risk of household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Milbemycin oxime:

Milbemycin oxime is an antiparasitic endectocide belonging to the group of macrocyclic lactones. Milbemycin oxime contains two major factors, A3 and A4 (ratio of 20:80 for A3:A4). It is a fermentation product of Streptomyces milbemycinicus. Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates. Milbemycin oxime increases glutamate binding with consequent enhanced chloride ion flow into the cell. This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.

Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).

Pharmaceutical particulars

Excipients

Maize starch, Soy protein, Braised beef flavouring, Povidone (E1201), Macrogol 400, Macrogol 4000, Macrogol 15 hydroxystearate, Glycerol (E422), Medium-chain triglycerides, Citric acid monohydrate (E330), Butyl-hydroxytoluene (E321).

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the product as packaged for sale: 2 years.

Special precautions for storage

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

Immediate packaging

The product is individually packaged in plastic blisters. One carton contains one blister of 1, 3 or 6 chewable tablets. Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Merial

29, avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/14/177/001-015

Legal category

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews (9)

Q & A

Below are some recent questions we've received regarding NexGard Spectra, including answers from our team.

18 December 2015 at 12:42pm

Is it 2 in 1?

Myrto Geranopoulou

  • VioVet customer since 2012
  • From: ATTICA, Greece

My dog is 16,5 kg.
Do I give him a chewable NexGard Spectra, instead of a pipette once a month and a Drontal once every 3 months?

  • Non-Executive Director

Yes this would be good, though theoretically you only need to give a Droncit, not a Drontal, every 3 months. (Droncit is just for tapeworms and that is all you need along with NexGard. Drontal has an extra ingredient to control roundworms, which are covered by the NexGard anyway.) It would be safe enough either way, but ideally you avoid giving unnecessary medication.