Target species
Dogs
Use the appropriate Advantix Spot-on solution product (see section Amounts to be administered and administration route).
Indications for use, specifying the target species
For dogs with, or at risk from mixed infestations by fleas, biting lice, ticks, sand flies, mosquitos and stable flies. The veterinary medicinal product is only indicated when used against all the following parasite species is required at the same time.
For the treatment and prevention of flea (Ctenocephalides canis, Ctenocephalides felis) infestation.
Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Treatment of biting lice (Trichodectes canis).
The veterinary medicinal product has persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus and Ixodes ricinus for four weeks, and Dermacentor reticulatus for three weeks).
Reduction of the risk of transmission of the vector-borne pathogen Ehrlichia canis, thereby reducing the risk of canine ehrlichiosis by acaricidal and repellent activity on the tick vector Rhipicephalus sanguineus. The reduction in risk has been shown to begin from three days following application of the veterinary medicinal product and to persist for four 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.
Reduction of the risk of transmission infection of the vector-borne pathogen Leishmania infantum thereby reducing the risk of canine leishmaniosis by repellent (anti-feeding) activity on sandflies (vector Phlebotomus papatasi) for up to two weeks and vector Phlebotomus perniciosus for three weeks). The effect is indirect due to veterinary medicinal product’s activity against the vector.
Contraindications
In the absence of available data the veterinary medicinal product should not be used on puppies of less than 7 weeks of age or 1.5 kg of weight. According to the dog’s body weight the corresponding Advantix product must be used, see dosing scheme.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Do not use on cats. (See section – Special precautions for use).
Special warnings for each target species
It is recommended to apply the treatment at least three days before expected exposure to Ehrlichia 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 three days following application of the veterinary medicinal product and to persist for four weeks.
Immediate protection against sandflies bites is not documented. Treated dogs for the reduction of the risk of infection with Leishmania infantum via transmission by sandflies Phlebotomus perniciosus should be kept in a protected environment during the first 24 hours after the initial treatment application.
To reduce re-infestation from emergence of new fleas, it is recommended to treat all dogs in a household. Other animals living in the same household should also be treated with a suitable product. To aid further in reducing environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developmental stages is recommended.
The veterinary medicinal 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 the veterinary medicinal product or at least 2 weeks after application, to optimise efficacy of the veterinary medicinal product.
The possibility that other animals in the same household can be a source of re-infection with fleas, biting lice, ticks, mosquitoes and flies should be considered, and these should be treated as necessary with an appropriate product.
In the absence of risk of co-infection, a narrow spectrum veterinary product should be used. The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.
In Europe, resistance to pyrethroids has been reported in isolated cases of Rhipicephalus sanguineus and Stomoxys calcitrans. Current knowledge suggests that resistance in both parasites is conferred by gene mutations at the target site while other factors like metabolic detoxification may also play a role
Special precautions for use
Special precautions for use in animals
Care should be taken to avoid the content of the pipette coming into contact with the eyes or mouth of the recipient dogs.
Care should be taken to administer the veterinary medicinal product correctly as described under section Amounts to be administered and administration route. In particular oral uptake due to the licking of the application site by treated or in-contact animals should be avoided.
Do not use on cats.
This veterinary medicinal product is extremely poisonous to cats and could be fatal due to the unique physiology of cats which is unable to metabolise certain compounds including permethrin. To prevent cats from being accidentally exposed to the veterinary medicinal product, keep treated dogs away from cats after treatment 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 veterinary medicinal product. Seek veterinary advice immediately if this occurs.
Consult your veterinary surgeon before using the veterinary medicinal product on sick and debilitated dogs.
Ticks will be killed and fall off the host within 24 to 48 hours after infestation without having a blood meal, as a rule. An attachment of single ticks after treatment cannot be excluded. For this reason, a transmission of infectious diseases by ticks cannot be completely excluded if conditions are unfavourable.
After treatment an attachment of single ticks or bites by single sand flies or mosquitoes cannot be excluded or a transmission of infectious diseases cannot be completely excluded since the insect has to attach to the host before achieving the ectoparasiticidal effect. The protection may be insufficient during the first hours/days after the administration of the veterinary medicinal product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact between the veterinary medicinal 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.
People with known hypersensitivity to imidacloprid and permethrin should administer the veterinary medicinal product with caution.
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 veterinary medicinal product gets accidentally into the eyes, the eyes should be thoroughly flushed with water. If skin or if eye irritation persists, seek medical advice immediately and show the package leaflet or the label 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.
Laboratory studies in rabbits and rats with the excipient N-methylpyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.
Special precautions for the protection of the environment:
As the veterinary medicinal 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.
Other precautions
The solvent in this veterinary medicinal product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Adverse events
Uncommon (1 to 10 animals / 1,000 animals treated): | Application site hair change (e.g. greasy fur), Application site itching Vomiting |
Rare (1 to 10 animals / 10,000 animals treated): | Application site erythema, Application site hair loss, Application site inflammation Diarrhoea |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Agitation1,2,4, Restlessness1,2,4, Rolling1,2,4, Whining1,2,4 Hypersalivation1,2,4 Decreased appetite1,2,4, Lethargy1,3 Neurological signs (Abnormal movement and Twitching)1,2,4, Tremor3 Rubbing1,4, Scratching1,4 |
1 Generally self-resolving.
2 In dogs susceptible to permethrin.
3 Following inadvertent oral uptake in dog. There is no known specific antidote; symptomatic treatment recommended.
4 Transient.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Spot-on use. For external use only. Apply only to undamaged skin.
The recommended minimum dose is:
10 mg/kg body weight (bw) imidacloprid and 50 mg/kg body weight (bw) permethrin.
Dosing Scheme: |
Dogs
(kg bw) | Trade name | Volume
(ml) | Imidacloprid
(mg/kg body weight) | Permethrin
(mg/kg body weight) |
≤ 4 kg | Advantix 40mg + 200mg | 0.4 ml | minimum of 10 | minimum of 50 |
>4 kg ≤ 10 kg | Advantix 100mg + 500mg | 1.0 ml | 10 - 25 | 50 - 125 |
>10 kg ≤ 25 kg | Advantix 250mg + 1250mg | 2.5 ml | 10 - 25 | 50 - 125 |
>25 kg ≤ 40 kg | Advantix 400mg + 2000mg | 4.0 ml | 10 - 16 | 50 - 80 |
>40 kg | The appropriate combination of pipettes should be used | | | |
Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Ticks, fleas:
The need and frequency of re-treatment(s) should be based on local epidemiological situation and the animal’s lifestyle.
Biting lice:
In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Sand flies:
To protect a dog over the whole sand fly season, treatment should be compliantly continued throughout.
Method for administration |
Remove one pipette from the package. Hold applicator pipette in an upright position, twist and pull cap off. Turn the cap around and place the other end of cap back on pipette. Twist cap to break seal, then remove cap from pipette. |
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For dogs 10 kg body weight or less: | For dogs of more than 10 kg body weight: |
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. | With the dog standing still, the entire contents of the pipette should be applied evenly to four 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 on 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. |
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Overdose (symptoms, emergency procedures, antidotes), if necessary
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 veterinary medicinal product.
Withdrawal period(s)
Not applicable.