Advantix is a clear yellowish to brownish, non-aqueous solution containing imidacloprid and permethrin. The product is presented in a single use plastic pipette for dermal (spot-on) treatment in dogs. Each pipette contains 0.4ml (40 mg imidacloprid, 200 mg permethrin), 1.0 ml (100 mg imidacloprid, 500 mg permethrin), 2.5 ml (250 mg imidacloprid, 1250 mg permethrin) and 4 ml (400 mg imidacloprid, 2000 mg permethrin) respectively, as listed above. The product also contains 0.1% w/v butylated hydroxytoluene (E321) as a preservative.
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). 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).
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.
Flies, 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.
The recommended minimum dose is 10 mg/kg body weight imidacloprid and 50 mg/kg body weight permethrin. 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.
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. With the dog in a standing position 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. For dermal use only. Apply only to undamaged skin. 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 known hypersensitivity to the active substances. Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient dog. Care should be taken to administer the product correctly as described above, 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 (including 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 under veterinary medical attention. There is no known specific antidote.
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. However, 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).
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.
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 on to 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 eye irritation persists, or if the product is accidentally swallowed, obtain medical attention immediately and show the package insert to the physician. Treated dogs should not be handled, especially by children, until the application site is dry. This may be ensured by treating dogs when children are not present, e.g. in the evening after children have gone to bed. Recently treated dogs should not be allowed to sleep together with their owner, especially children.
Environmental Safety; The product should not be allowed to enter water courses as this may be dangerous for fish and aquatic organisms. Treated dogs must not under any circumstances be allowed to enter any type of surface water for at least 48 hours after treatment. Permethrin containing products are toxic to honey bees.
Pharmaceutical precautions; Do not freeze. After opening the foil pouch do not store above 30°C. Once opened, the entire contents of the pipette has to be applied to the animal's skin. All pipettes should be used within 24 months after opening the foil pouch or before expiry date on the pipette, whichever is shorter.After use, replace cap on tube. Any unused product or waste material should be disposed of in accordance with national requirements.
Legal category; POM-V
Packaging Quantities; Polychlorotrifluoroethylene PCTFE/PVC heat sealed blister packs in an aluminium pouch and a cardboard box, containing 4 white polypropylene pipettes in a sealed aluminium pouch, packed with an instruction sheet into a cardboard box.
Further information; 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 disease transmission (e.g. Borreliosis, Rickettsiosis, Ehrlichiosis, Leishmaniasis). 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.
There is no known interaction with other medicaments or other forms of interaction. No adverse clinical signs were noted in healthy puppies and adult dogs exposed to 5 x overdosage, and for puppies whose mothers were treated with 3 x overdosage of the product. 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.
Advantix marketing authorisation number; Vm 00010/4136 - 4139.