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Advantix Spot-on for Dogs - Pet Health Direct
Advantix Spot-on for Dogs - Pet Health Direct
Advantix Spot-on for Dogs - Pet Health Direct
Advantix Spot-on for Dogs - Pet Health Direct
Advantix Spot-on for Dogs - Pet Health Direct
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Advantix Spot-on for Dogs

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Advantix is the parasite treatment for dogs which has been shown to provide the highest degree of protection against fleas, ticks, mosquitoes, sandflies and stable flies. It is supplied in small pipettes containing imidacloprid and permethrin. Advantix can be used for dogs in the UK where both flea and tick control is required. However it is intended more for dogs living or travelling in Europe. Several serious diseases can be transmitted to dogs, especially in Southern Europe/ Mediterranean countries, by biting insects and similar pests. Regular application of Advantix has been shown to be effective in controlling diseases such as Ehrlichiosis and Leishmaniasis in dogs living in areas where these disease occur naturally. A single, monthly application is all that is required to provide safe protection to dogs. This product should not be used on cats.

40 For Small Dogs Up To 4kg (Pack Of 4 Pipettes) 

Advantix

Presentation

A clear yellowish to brownish, solution containing imidacloprid and permethrin (40/60) as active substances and 1.0 mg/ml butylhydroxytoluene (E321) as an antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) treatment in dogs. Each pipette contains either 0.4 ml (40 mg imidacloprid, 200 mg permethrin (40/60)), 1.0 ml (100 mg imidacloprid, 500 mg permethrin (40/60)), 2.5 ml (250 mg imidacloprid, 1250 mg permethrin (40/60)) or 4.0 ml (400 mg imidacloprid, 2000 mg permethrin (40/60)).

Uses

For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestations in dogs only.

Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

For the treatment of biting lice (Trichodectes canis).

The product has a persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus, Ixodes ricinus for four weeks, and Dermacentor reticulatus for three weeks).

By repelling and killing the tick vector Rhipicephalus sanguineus, the product reduces the likelihood of transmission of the pathogen Ehrlichia canis, thereby reducing the risk of canine ehrlichiosis. The reduction in risk has been shown in studies to commence from 3 days following application of the product and to persist for 4 weeks.

Ticks already on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal.

One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus papatasi for two weeks and Phlebotomus perniciosus for three weeks), against mosquitoes (Aedes aegypti for two weeks and Culex pipiens for four weeks) and against stable flies (Stomoxys calcitrans) for four weeks.

Sand flies Phlebotomus papatasi 2 weeks
Phlebotomus perniciosus 3 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stables flies Stomoxys calcitrans 4 weeks

Dosage and administration

The recommended minimum dose is:

10 mg/kg body weight imidacloprid and 50 mg/kg body weight permethrin.

For dermal use only. Apply only to undamaged skin.

Please refer to Table 1 for the dosing scheme for Advantix Spot-on.

To reduce re-infestation from emergence of new fleas it is recommended that all dogs in a household be treated. Other pet animals living in the same household should also be treated with a suitable product. To further aid in reducing environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developmental stages is recommended.

The product remains effective if the animal becomes wet. However, prolonged, intense exposure to water should be avoided. In cases of frequent water exposure the persistent efficacy may be reduced. In these cases do not retreat more frequently than once weekly. If a dog requires a shampoo, it should be administered before applying Advantix or at least 2 weeks after application, to optimise efficacy of the product.

In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of Administration

Remove one pipette from the package. Hold pipette in an upright position, twist and pull cap off. Turn the cap around and place the other end of the cap back on the pipette. Twist cap to break seal, then remove cap from pipette. See Figure 1.

Figure 1: Opening a pipette

Figure 1: Opening a pipette

Administration to dogs weighing up to 10 kg

With the dog standing still, part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. See Figure 2.

Figure 2: Administration to dogs up to 10kg

Figure 2: Administration to dogs up to 10kg

Administration to dogs weighing over 10 kg

With the dog standing still, the entire contents of the Advantix pipette(s) should be applied evenly to several spots on the top of the back from the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to expel a portion of the solution onto the skin. Do not apply an excessive amount of solution at any one spot that could cause some of the solution to run off the side of the dog. See Figure 3.

Figure 3: Administration to dogs over 10 kg

Figure 3: Administration to dogs over 10 kg

Use during pregnancy and lactation

The product may be used during pregnancy and lactation.

Contra-indications, warnings, etc

Do not use on cats.This product is extremely poisonous to cats and could be fatal due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product. Seek veterinary advice immediately if this occurs.

In the absence of available data, the product should not be used on puppies of less than 7 weeks of age or 1.5 kg of weight.

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

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient dogs.

Care should be taken to administer the product correctly as described under Method of Administration. In particular, oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.

Consult your veterinary surgeon before using the product on sick and debilitated dogs.

On very rare occasions reactions in dogs may include transient skin sensitivity (increased local itching, scratching and rubbing, hair loss and redness at the application site) or lethargy that are generally self-resolving.

In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching in dogs susceptible to the ingredient permethrin. These signs are generally transient and self-resolving.

Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic. There is no known specific antidote.

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).

There may be an attachment of single ticks, or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable.

It is recommended to apply the treatment at least 3 days before expected exposure to E. canis. With regard to E. canis, studies have demonstrated a reduced risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis from 3 days following application of the product and to persist for 4 weeks.

No adverse clinical signs were noted in healthy puppies or adult dogs exposed to 5x overdosage or for puppies whose mothers were treated with 3x overdosage of the product.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

The solvent in Advantix Spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact between the product and skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with known skin sensitivity may be particularly sensitive to this product.

The predominant clinical symptoms that in extremely rare case may be shown are transient sensory irritations of the skin like tingling, burning sensation or numbness.

If the product gets accidentally into the eyes, they should be thoroughly flushed with water. If skin or if eye irritation persists obtain medical attention immediately and show the package insert to the physician.

Do not ingest. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Treated dogs should not be handled especially by children until the application site is dry. This may be ensured by treating the dogs e.g. in the evening. Recently treated dogs should not be allowed to sleep together with their owner, especially children.

In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.

Environmental Safety

The product should not be allowed to enter water courses, as this may be dangerous for fish and aquatic organisms.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

Permethrin-containing products are toxic to honey bees.

After use, replace cap on tube. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not freeze.

After opening the foil pouch store in a dry place at a temperature not above 30°C.

After use, replace cap on tube.

Shelf-life of product in foil pouch: 5 years

Shelf-life of product after opening foil pouch: 2 years (all pipettes should be used within 2 years after opening the foil pouch or before expiry date on the pipette, whichever is shorter).

Shelf-life of the broached pipette: Not applicable, once opened, the entire contents of the pipette has to be applied to the animal's skin.

Legal category

Packaging quantities

Polychlorotrifluoroethylene PCTFE/PVC heat-sealed blister packs in an aluminium pouch, containing 4 white polypropylene pipettes with white polypropylene caps, packed with an instruction sheet into a cardboard box.

Further information

Pharmacotherapeutic group: antiparasitic agent, ATC vet code: QP53AC54

Advantix Spot-on is an ectoparasiticide for topical use containing imidacloprid and permethrin. This combination acts as an insecticide, acaricide and as a repellent.

Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the dog`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Permethrin belongs to the type I class of pyrethroid acaricides and insecticides and also acts as repellent. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non-vertebrates. Pyrethroids are so called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties thus leading to hyperexcitability and death of the parasite.

In the combination of both substances, it has been shown Imidacloprid functions as the activator of arthropod ganglion and therefore increases the efficacy of permethrin.

The product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing the repelled parasites from taking a blood meal and thus reducing the risk of Canine Vector-Borne Disease (CVBD) transmission (e.g. borreliosis, rickettsiosis, ehrlichiosis, leishmaniosis). However, there may be an attachment of single ticks or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. The product provides repellent (anti-feeding) activity against stable flies thereby assisting in the prevention of fly-bite dermatitis.

The product is indicated for dermal administration. Following topical application in dogs, the solution rapidly distributes over the body surface of the animal. Both active substances remain detectable on the skin and hair of the treated animal for 4 weeks. Acute dermal studies in the rat and target animal, overdose and serum kinetic studies have established that systemic absorption of both active substances after application on intact skin is low, transient and not relevant for the clinical efficacy.

Marketing Authorisation Number

Advantix Spot-on Solution for Dogs up to 4 kgVm 00879/4111Advantix Spot-on Solution for Dogs over 4 kg up to 10 kgVm 00879/4109Advantix Spot-on Solution for Dogs over 10 kg up to 25 kgVm 00879/4107Advantix Spot-on Solution for Dogs over 25 kg up to 40 kgVm 00879/4108

100 For Medium Dogs 4-10kg (Pack Of 4 Pipettes) 

Advantix

Presentation

A clear yellowish to brownish, solution containing imidacloprid and permethrin (40/60) as active substances and 1.0 mg/ml butylhydroxytoluene (E321) as an antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) treatment in dogs. Each pipette contains either 0.4 ml (40 mg imidacloprid, 200 mg permethrin (40/60)), 1.0 ml (100 mg imidacloprid, 500 mg permethrin (40/60)), 2.5 ml (250 mg imidacloprid, 1250 mg permethrin (40/60)) or 4.0 ml (400 mg imidacloprid, 2000 mg permethrin (40/60)).

Uses

For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestations in dogs only.

Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

For the treatment of biting lice (Trichodectes canis).

The product has a persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus, Ixodes ricinus for four weeks, and Dermacentor reticulatus for three weeks).

By repelling and killing the tick vector Rhipicephalus sanguineus, the product reduces the likelihood of transmission of the pathogen Ehrlichia canis, thereby reducing the risk of canine ehrlichiosis. The reduction in risk has been shown in studies to commence from 3 days following application of the product and to persist for 4 weeks.

Ticks already on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal.

One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus papatasi for two weeks and Phlebotomus perniciosus for three weeks), against mosquitoes (Aedes aegypti for two weeks and Culex pipiens for four weeks) and against stable flies (Stomoxys calcitrans) for four weeks.

Sand flies Phlebotomus papatasi 2 weeks
Phlebotomus perniciosus 3 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stables flies Stomoxys calcitrans 4 weeks

Dosage and administration

The recommended minimum dose is:

10 mg/kg body weight imidacloprid and 50 mg/kg body weight permethrin.

For dermal use only. Apply only to undamaged skin.

Please refer to Table 1 for the dosing scheme for Advantix Spot-on.

To reduce re-infestation from emergence of new fleas it is recommended that all dogs in a household be treated. Other pet animals living in the same household should also be treated with a suitable product. To further aid in reducing environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developmental stages is recommended.

The product remains effective if the animal becomes wet. However, prolonged, intense exposure to water should be avoided. In cases of frequent water exposure the persistent efficacy may be reduced. In these cases do not retreat more frequently than once weekly. If a dog requires a shampoo, it should be administered before applying Advantix or at least 2 weeks after application, to optimise efficacy of the product.

In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of Administration

Remove one pipette from the package. Hold pipette in an upright position, twist and pull cap off. Turn the cap around and place the other end of the cap back on the pipette. Twist cap to break seal, then remove cap from pipette. See Figure 1.

Figure 1: Opening a pipette

Figure 1: Opening a pipette

Administration to dogs weighing up to 10 kg

With the dog standing still, part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. See Figure 2.

Figure 2: Administration to dogs up to 10kg

Figure 2: Administration to dogs up to 10kg

Administration to dogs weighing over 10 kg

With the dog standing still, the entire contents of the Advantix pipette(s) should be applied evenly to several spots on the top of the back from the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to expel a portion of the solution onto the skin. Do not apply an excessive amount of solution at any one spot that could cause some of the solution to run off the side of the dog. See Figure 3.

Figure 3: Administration to dogs over 10 kg

Figure 3: Administration to dogs over 10 kg

Use during pregnancy and lactation

The product may be used during pregnancy and lactation.

Contra-indications, warnings, etc

Do not use on cats.This product is extremely poisonous to cats and could be fatal due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product. Seek veterinary advice immediately if this occurs.

In the absence of available data, the product should not be used on puppies of less than 7 weeks of age or 1.5 kg of weight.

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

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient dogs.

Care should be taken to administer the product correctly as described under Method of Administration. In particular, oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.

Consult your veterinary surgeon before using the product on sick and debilitated dogs.

On very rare occasions reactions in dogs may include transient skin sensitivity (increased local itching, scratching and rubbing, hair loss and redness at the application site) or lethargy that are generally self-resolving.

In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching in dogs susceptible to the ingredient permethrin. These signs are generally transient and self-resolving.

Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic. There is no known specific antidote.

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).

There may be an attachment of single ticks, or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable.

It is recommended to apply the treatment at least 3 days before expected exposure to E. canis. With regard to E. canis, studies have demonstrated a reduced risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis from 3 days following application of the product and to persist for 4 weeks.

No adverse clinical signs were noted in healthy puppies or adult dogs exposed to 5x overdosage or for puppies whose mothers were treated with 3x overdosage of the product.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

The solvent in Advantix Spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact between the product and skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with known skin sensitivity may be particularly sensitive to this product.

The predominant clinical symptoms that in extremely rare case may be shown are transient sensory irritations of the skin like tingling, burning sensation or numbness.

If the product gets accidentally into the eyes, they should be thoroughly flushed with water. If skin or if eye irritation persists obtain medical attention immediately and show the package insert to the physician.

Do not ingest. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Treated dogs should not be handled especially by children until the application site is dry. This may be ensured by treating the dogs e.g. in the evening. Recently treated dogs should not be allowed to sleep together with their owner, especially children.

In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.

Environmental Safety

The product should not be allowed to enter water courses, as this may be dangerous for fish and aquatic organisms.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

Permethrin-containing products are toxic to honey bees.

After use, replace cap on tube. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not freeze.

After opening the foil pouch store in a dry place at a temperature not above 30°C.

After use, replace cap on tube.

Shelf-life of product in foil pouch: 5 years

Shelf-life of product after opening foil pouch: 2 years (all pipettes should be used within 2 years after opening the foil pouch or before expiry date on the pipette, whichever is shorter).

Shelf-life of the broached pipette: Not applicable, once opened, the entire contents of the pipette has to be applied to the animal's skin.

Legal category

Packaging quantities

Polychlorotrifluoroethylene PCTFE/PVC heat-sealed blister packs in an aluminium pouch, containing 4 white polypropylene pipettes with white polypropylene caps, packed with an instruction sheet into a cardboard box.

Further information

Pharmacotherapeutic group: antiparasitic agent, ATC vet code: QP53AC54

Advantix Spot-on is an ectoparasiticide for topical use containing imidacloprid and permethrin. This combination acts as an insecticide, acaricide and as a repellent.

Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the dog`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Permethrin belongs to the type I class of pyrethroid acaricides and insecticides and also acts as repellent. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non-vertebrates. Pyrethroids are so called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties thus leading to hyperexcitability and death of the parasite.

In the combination of both substances, it has been shown Imidacloprid functions as the activator of arthropod ganglion and therefore increases the efficacy of permethrin.

The product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing the repelled parasites from taking a blood meal and thus reducing the risk of Canine Vector-Borne Disease (CVBD) transmission (e.g. borreliosis, rickettsiosis, ehrlichiosis, leishmaniosis). However, there may be an attachment of single ticks or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. The product provides repellent (anti-feeding) activity against stable flies thereby assisting in the prevention of fly-bite dermatitis.

The product is indicated for dermal administration. Following topical application in dogs, the solution rapidly distributes over the body surface of the animal. Both active substances remain detectable on the skin and hair of the treated animal for 4 weeks. Acute dermal studies in the rat and target animal, overdose and serum kinetic studies have established that systemic absorption of both active substances after application on intact skin is low, transient and not relevant for the clinical efficacy.

Marketing Authorisation Number

Advantix Spot-on Solution for Dogs up to 4 kgVm 00879/4111Advantix Spot-on Solution for Dogs over 4 kg up to 10 kgVm 00879/4109Advantix Spot-on Solution for Dogs over 10 kg up to 25 kgVm 00879/4107Advantix Spot-on Solution for Dogs over 25 kg up to 40 kgVm 00879/4108

250 For Large Dogs 10-25kg (Pack Of 4 Pipettes) 

Advantix

Presentation

A clear yellowish to brownish, solution containing imidacloprid and permethrin (40/60) as active substances and 1.0 mg/ml butylhydroxytoluene (E321) as an antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) treatment in dogs. Each pipette contains either 0.4 ml (40 mg imidacloprid, 200 mg permethrin (40/60)), 1.0 ml (100 mg imidacloprid, 500 mg permethrin (40/60)), 2.5 ml (250 mg imidacloprid, 1250 mg permethrin (40/60)) or 4.0 ml (400 mg imidacloprid, 2000 mg permethrin (40/60)).

Uses

For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestations in dogs only.

Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

For the treatment of biting lice (Trichodectes canis).

The product has a persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus, Ixodes ricinus for four weeks, and Dermacentor reticulatus for three weeks).

By repelling and killing the tick vector Rhipicephalus sanguineus, the product reduces the likelihood of transmission of the pathogen Ehrlichia canis, thereby reducing the risk of canine ehrlichiosis. The reduction in risk has been shown in studies to commence from 3 days following application of the product and to persist for 4 weeks.

Ticks already on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal.

One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus papatasi for two weeks and Phlebotomus perniciosus for three weeks), against mosquitoes (Aedes aegypti for two weeks and Culex pipiens for four weeks) and against stable flies (Stomoxys calcitrans) for four weeks.

Sand flies Phlebotomus papatasi 2 weeks
Phlebotomus perniciosus 3 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stables flies Stomoxys calcitrans 4 weeks

Dosage and administration

The recommended minimum dose is:

10 mg/kg body weight imidacloprid and 50 mg/kg body weight permethrin.

For dermal use only. Apply only to undamaged skin.

Please refer to Table 1 for the dosing scheme for Advantix Spot-on.

To reduce re-infestation from emergence of new fleas it is recommended that all dogs in a household be treated. Other pet animals living in the same household should also be treated with a suitable product. To further aid in reducing environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developmental stages is recommended.

The product remains effective if the animal becomes wet. However, prolonged, intense exposure to water should be avoided. In cases of frequent water exposure the persistent efficacy may be reduced. In these cases do not retreat more frequently than once weekly. If a dog requires a shampoo, it should be administered before applying Advantix or at least 2 weeks after application, to optimise efficacy of the product.

In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of Administration

Remove one pipette from the package. Hold pipette in an upright position, twist and pull cap off. Turn the cap around and place the other end of the cap back on the pipette. Twist cap to break seal, then remove cap from pipette. See Figure 1.

Figure 1: Opening a pipette

Figure 1: Opening a pipette

Administration to dogs weighing up to 10 kg

With the dog standing still, part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. See Figure 2.

Figure 2: Administration to dogs up to 10kg

Figure 2: Administration to dogs up to 10kg

Administration to dogs weighing over 10 kg

With the dog standing still, the entire contents of the Advantix pipette(s) should be applied evenly to several spots on the top of the back from the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to expel a portion of the solution onto the skin. Do not apply an excessive amount of solution at any one spot that could cause some of the solution to run off the side of the dog. See Figure 3.

Figure 3: Administration to dogs over 10 kg

Figure 3: Administration to dogs over 10 kg

Use during pregnancy and lactation

The product may be used during pregnancy and lactation.

Contra-indications, warnings, etc

Do not use on cats.This product is extremely poisonous to cats and could be fatal due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product. Seek veterinary advice immediately if this occurs.

In the absence of available data, the product should not be used on puppies of less than 7 weeks of age or 1.5 kg of weight.

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

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient dogs.

Care should be taken to administer the product correctly as described under Method of Administration. In particular, oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.

Consult your veterinary surgeon before using the product on sick and debilitated dogs.

On very rare occasions reactions in dogs may include transient skin sensitivity (increased local itching, scratching and rubbing, hair loss and redness at the application site) or lethargy that are generally self-resolving.

In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching in dogs susceptible to the ingredient permethrin. These signs are generally transient and self-resolving.

Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic. There is no known specific antidote.

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).

There may be an attachment of single ticks, or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable.

It is recommended to apply the treatment at least 3 days before expected exposure to E. canis. With regard to E. canis, studies have demonstrated a reduced risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis from 3 days following application of the product and to persist for 4 weeks.

No adverse clinical signs were noted in healthy puppies or adult dogs exposed to 5x overdosage or for puppies whose mothers were treated with 3x overdosage of the product.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

The solvent in Advantix Spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact between the product and skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with known skin sensitivity may be particularly sensitive to this product.

The predominant clinical symptoms that in extremely rare case may be shown are transient sensory irritations of the skin like tingling, burning sensation or numbness.

If the product gets accidentally into the eyes, they should be thoroughly flushed with water. If skin or if eye irritation persists obtain medical attention immediately and show the package insert to the physician.

Do not ingest. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Treated dogs should not be handled especially by children until the application site is dry. This may be ensured by treating the dogs e.g. in the evening. Recently treated dogs should not be allowed to sleep together with their owner, especially children.

In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.

Environmental Safety

The product should not be allowed to enter water courses, as this may be dangerous for fish and aquatic organisms.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

Permethrin-containing products are toxic to honey bees.

After use, replace cap on tube. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not freeze.

After opening the foil pouch store in a dry place at a temperature not above 30°C.

After use, replace cap on tube.

Shelf-life of product in foil pouch: 5 years

Shelf-life of product after opening foil pouch: 2 years (all pipettes should be used within 2 years after opening the foil pouch or before expiry date on the pipette, whichever is shorter).

Shelf-life of the broached pipette: Not applicable, once opened, the entire contents of the pipette has to be applied to the animal's skin.

Legal category

Packaging quantities

Polychlorotrifluoroethylene PCTFE/PVC heat-sealed blister packs in an aluminium pouch, containing 4 white polypropylene pipettes with white polypropylene caps, packed with an instruction sheet into a cardboard box.

Further information

Pharmacotherapeutic group: antiparasitic agent, ATC vet code: QP53AC54

Advantix Spot-on is an ectoparasiticide for topical use containing imidacloprid and permethrin. This combination acts as an insecticide, acaricide and as a repellent.

Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the dog`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Permethrin belongs to the type I class of pyrethroid acaricides and insecticides and also acts as repellent. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non-vertebrates. Pyrethroids are so called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties thus leading to hyperexcitability and death of the parasite.

In the combination of both substances, it has been shown Imidacloprid functions as the activator of arthropod ganglion and therefore increases the efficacy of permethrin.

The product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing the repelled parasites from taking a blood meal and thus reducing the risk of Canine Vector-Borne Disease (CVBD) transmission (e.g. borreliosis, rickettsiosis, ehrlichiosis, leishmaniosis). However, there may be an attachment of single ticks or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. The product provides repellent (anti-feeding) activity against stable flies thereby assisting in the prevention of fly-bite dermatitis.

The product is indicated for dermal administration. Following topical application in dogs, the solution rapidly distributes over the body surface of the animal. Both active substances remain detectable on the skin and hair of the treated animal for 4 weeks. Acute dermal studies in the rat and target animal, overdose and serum kinetic studies have established that systemic absorption of both active substances after application on intact skin is low, transient and not relevant for the clinical efficacy.

Marketing Authorisation Number

Advantix Spot-on Solution for Dogs up to 4 kgVm 00879/4111Advantix Spot-on Solution for Dogs over 4 kg up to 10 kgVm 00879/4109Advantix Spot-on Solution for Dogs over 10 kg up to 25 kgVm 00879/4107Advantix Spot-on Solution for Dogs over 25 kg up to 40 kgVm 00879/4108

400 For X-Large Dogs Over 25kg (Pack Of 4 Pipettes) 

Advantix

Presentation

A clear yellowish to brownish, solution containing imidacloprid and permethrin (40/60) as active substances and 1.0 mg/ml butylhydroxytoluene (E321) as an antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) treatment in dogs. Each pipette contains either 0.4 ml (40 mg imidacloprid, 200 mg permethrin (40/60)), 1.0 ml (100 mg imidacloprid, 500 mg permethrin (40/60)), 2.5 ml (250 mg imidacloprid, 1250 mg permethrin (40/60)) or 4.0 ml (400 mg imidacloprid, 2000 mg permethrin (40/60)).

Uses

For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestations in dogs only.

Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

For the treatment of biting lice (Trichodectes canis).

The product has a persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus, Ixodes ricinus for four weeks, and Dermacentor reticulatus for three weeks).

By repelling and killing the tick vector Rhipicephalus sanguineus, the product reduces the likelihood of transmission of the pathogen Ehrlichia canis, thereby reducing the risk of canine ehrlichiosis. The reduction in risk has been shown in studies to commence from 3 days following application of the product and to persist for 4 weeks.

Ticks already on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore the removal of ticks already on the dog at the time of treatment is recommended, in order to prevent them from attaching and having a blood meal.

One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus papatasi for two weeks and Phlebotomus perniciosus for three weeks), against mosquitoes (Aedes aegypti for two weeks and Culex pipiens for four weeks) and against stable flies (Stomoxys calcitrans) for four weeks.

Sand flies Phlebotomus papatasi 2 weeks
Phlebotomus perniciosus 3 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stables flies Stomoxys calcitrans 4 weeks

Dosage and administration

The recommended minimum dose is:

10 mg/kg body weight imidacloprid and 50 mg/kg body weight permethrin.

For dermal use only. Apply only to undamaged skin.

Please refer to Table 1 for the dosing scheme for Advantix Spot-on.

To reduce re-infestation from emergence of new fleas it is recommended that all dogs in a household be treated. Other pet animals living in the same household should also be treated with a suitable product. To further aid in reducing environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developmental stages is recommended.

The product remains effective if the animal becomes wet. However, prolonged, intense exposure to water should be avoided. In cases of frequent water exposure the persistent efficacy may be reduced. In these cases do not retreat more frequently than once weekly. If a dog requires a shampoo, it should be administered before applying Advantix or at least 2 weeks after application, to optimise efficacy of the product.

In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of Administration

Remove one pipette from the package. Hold pipette in an upright position, twist and pull cap off. Turn the cap around and place the other end of the cap back on the pipette. Twist cap to break seal, then remove cap from pipette. See Figure 1.

Figure 1: Opening a pipette

Figure 1: Opening a pipette

Administration to dogs weighing up to 10 kg

With the dog standing still, part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. See Figure 2.

Figure 2: Administration to dogs up to 10kg

Figure 2: Administration to dogs up to 10kg

Administration to dogs weighing over 10 kg

With the dog standing still, the entire contents of the Advantix pipette(s) should be applied evenly to several spots on the top of the back from the shoulder to the base of the tail. At each spot, part the hair until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to expel a portion of the solution onto the skin. Do not apply an excessive amount of solution at any one spot that could cause some of the solution to run off the side of the dog. See Figure 3.

Figure 3: Administration to dogs over 10 kg

Figure 3: Administration to dogs over 10 kg

Use during pregnancy and lactation

The product may be used during pregnancy and lactation.

Contra-indications, warnings, etc

Do not use on cats.This product is extremely poisonous to cats and could be fatal due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product. Seek veterinary advice immediately if this occurs.

In the absence of available data, the product should not be used on puppies of less than 7 weeks of age or 1.5 kg of weight.

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

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient dogs.

Care should be taken to administer the product correctly as described under Method of Administration. In particular, oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.

Consult your veterinary surgeon before using the product on sick and debilitated dogs.

On very rare occasions reactions in dogs may include transient skin sensitivity (increased local itching, scratching and rubbing, hair loss and redness at the application site) or lethargy that are generally self-resolving.

In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (vomiting, diarrhoea, hypersalivation, diminished appetite) and neurological signs such as unsteady movement and twitching in dogs susceptible to the ingredient permethrin. These signs are generally transient and self-resolving.

Poisoning following inadvertent oral uptake in dogs is unlikely but may occur in very rare cases. In this event, neurological signs such as tremor and lethargy can occur. Treatment should be symptomatic. There is no known specific antidote.

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).

There may be an attachment of single ticks, or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable.

It is recommended to apply the treatment at least 3 days before expected exposure to E. canis. With regard to E. canis, studies have demonstrated a reduced risk of canine ehrlichiosis in dogs exposed to Rhipicephalus sanguineus ticks infected with E. canis from 3 days following application of the product and to persist for 4 weeks.

No adverse clinical signs were noted in healthy puppies or adult dogs exposed to 5x overdosage or for puppies whose mothers were treated with 3x overdosage of the product.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

The solvent in Advantix Spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

User Safety

Avoid contact between the product and skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with known skin sensitivity may be particularly sensitive to this product.

The predominant clinical symptoms that in extremely rare case may be shown are transient sensory irritations of the skin like tingling, burning sensation or numbness.

If the product gets accidentally into the eyes, they should be thoroughly flushed with water. If skin or if eye irritation persists obtain medical attention immediately and show the package insert to the physician.

Do not ingest. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Treated dogs should not be handled especially by children until the application site is dry. This may be ensured by treating the dogs e.g. in the evening. Recently treated dogs should not be allowed to sleep together with their owner, especially children.

In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.

Environmental Safety

The product should not be allowed to enter water courses, as this may be dangerous for fish and aquatic organisms.

As the product is dangerous to aquatic organisms, treated dogs must not under any circumstances be allowed into any type of surface water for at least 48 hours after treatment.

Permethrin-containing products are toxic to honey bees.

After use, replace cap on tube. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Do not freeze.

After opening the foil pouch store in a dry place at a temperature not above 30°C.

After use, replace cap on tube.

Shelf-life of product in foil pouch: 5 years

Shelf-life of product after opening foil pouch: 2 years (all pipettes should be used within 2 years after opening the foil pouch or before expiry date on the pipette, whichever is shorter).

Shelf-life of the broached pipette: Not applicable, once opened, the entire contents of the pipette has to be applied to the animal's skin.

Legal category

Packaging quantities

Polychlorotrifluoroethylene PCTFE/PVC heat-sealed blister packs in an aluminium pouch, containing 4 white polypropylene pipettes with white polypropylene caps, packed with an instruction sheet into a cardboard box.

Further information

Pharmacotherapeutic group: antiparasitic agent, ATC vet code: QP53AC54

Advantix Spot-on is an ectoparasiticide for topical use containing imidacloprid and permethrin. This combination acts as an insecticide, acaricide and as a repellent.

Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the dog`s immediate surroundings are killed following contact with a treated animal. It has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) in insects. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death of the parasite.

Permethrin belongs to the type I class of pyrethroid acaricides and insecticides and also acts as repellent. Pyrethroids affect the voltage-gated sodium channels in vertebrates and non-vertebrates. Pyrethroids are so called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties thus leading to hyperexcitability and death of the parasite.

In the combination of both substances, it has been shown Imidacloprid functions as the activator of arthropod ganglion and therefore increases the efficacy of permethrin.

The product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing the repelled parasites from taking a blood meal and thus reducing the risk of Canine Vector-Borne Disease (CVBD) transmission (e.g. borreliosis, rickettsiosis, ehrlichiosis, leishmaniosis). However, there may be an attachment of single ticks or bites by single sand flies or mosquitoes. For this reason, a transmission of infectious diseases by these parasites cannot be completely excluded if conditions are unfavourable. The product provides repellent (anti-feeding) activity against stable flies thereby assisting in the prevention of fly-bite dermatitis.

The product is indicated for dermal administration. Following topical application in dogs, the solution rapidly distributes over the body surface of the animal. Both active substances remain detectable on the skin and hair of the treated animal for 4 weeks. Acute dermal studies in the rat and target animal, overdose and serum kinetic studies have established that systemic absorption of both active substances after application on intact skin is low, transient and not relevant for the clinical efficacy.

Marketing Authorisation Number

Advantix Spot-on Solution for Dogs up to 4 kgVm 00879/4111Advantix Spot-on Solution for Dogs over 4 kg up to 10 kgVm 00879/4109Advantix Spot-on Solution for Dogs over 10 kg up to 25 kgVm 00879/4107Advantix Spot-on Solution for Dogs over 25 kg up to 40 kgVm 00879/4108

Datasheets:

Advantix 40 Dog Up To 4 kg (4pk)

Advantix 100 Dog 4-10 kg (4pk)

Advantix 250 Dog 10-25 kg (4pk)

Advantix 400 Dog >25kg (4pk)