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Clinical particulars
Target species
Cats and pet rabbits
Indications for use for each target species
Prevention and treatment of flea infestations on cats.
Treatment of flea infestations on pet rabbits.
Fleas are killed within one day following treatment. One treatment prevents further flea infestation on cats for 3-4 weeks and on rabbits for one week.
Contraindications
Do not treat unweaned kittens of less than 8 weeks of age.
Do not use on pet rabbits of less than 10 weeks of age.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. To aid reduction in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended. In order to reduce further the environmental challenge, it is recommended that all dogs, cats and rabbits in the household are treated, as necessary, with an appropriate product. Treatment of nursing bitches and queens controls flea infestations on both dam and offspring.
The veterinary medicinal product remains effective if the animal becomes wet, for example after exposure to heavy rain or after swimming (dogs). However, re treatment may become necessary, depending on the presence of fleas in the environment. In these cases do not treat more frequently than once weekly.
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.
Special precautions for use
Special precautions for safe use in the target species:
This veterinary medicinal product is for topical use and should not be administered orally.
Apply only to undamaged skin.
Care should be taken to avoid the contents of the tube coming into contact with the eyes or mouth of the recipient animal.
Do not allow recently treated animals to groom each other.
Any collar should be removed prior to application of the veterinary medicinal product. Prior to re-fitting the collar, the treated area should be visually assessed to ensure it is dry.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Keep stored tubes in the original packaging until ready to use. In order to prevent children from getting access to used tubes, dispose of used tubes immediately. People with known hypersensitivity to imidacloprid should avoid contact with the veterinary medicinal product.
This product contains benzyl alcohol and may cause sensitisation or transient skin reactions (e.g. irritation, tingling).
Avoid contact between the veterinary medicinal product and skin, eyes or mouth.
Do not massage the application site.
If the veterinary medicinal product gets into eyes, flush thoroughly with water. If skin or eye irritation persists or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
Wash off any skin contamination with soap and water.
After application, do not stroke or groom treated animals until the application site is dry (typically within an hour or so). It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
Special precautions for the protection of the environment:
Imidacloprid is toxic to aquatic organisms. To avoid adverse effects on aquatic organisms, treated dogs should not be allowed to enter surface water for 48 hours after treatment.
Other precautions:
The solvent in this veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
Adverse events
Cats and rabbits.
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Agitation
Diarrhoea1, Hypersalivation2, Vomiting3
Neurologial disorders (e.g. Depression, Incoordination, Tremor)
Application site reaction (e.g. Hair loss, Itching, Reddening of the skin, Skin lesion)
1May occur after oral ingestion.
2May occur if the cat licks the application site immediately after treatment due to the bitter taste. This is not a sign of intoxication and disappears within some minutes without treatment.
3 May occur after oral ingestion, in cats.
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
No reproductive toxic effects have been observed in rats and no primary embryotoxic or teratogenic toxic effects have been observed during the studies on rats and rabbits. Studies on pregnant and lactating bitches, queens and does together with their offspring are limited. Evidence so far suggests that no adverse effects are to be expected in these animals.
Interaction with other medicinal products and other forms of interaction
No incompatibility has been observed between this veterinary medicinal product at twice the recommended dose and the following commonly used veterinary medicinal products: lufenuron, febantel, pyrantel and praziquantel (dogs) and lufenuron, pyrantel and praziquantel (cats). The compatibility of the veterinary medicinal product was also demonstrated with a wide range of routine treatments under field conditions including vaccination.
Administration routes and dosage
Spot-on use.
This product is for external use only and should not be administered orally. Underdosing could result in ineffective use and may favour resistance development. To ensure correct dosage, body weight should be determined as accurately as possible.
Dosage and treatment schedule
Cat
Product
Number of Tubes
mg/kg bw
Less than 4kg body weight
Advantage 40 mg Spot- On Solution for Small Cats, Small Dogs and Pet Rabbits
1 x 0.4 ml
Minimum of 10
4kg body weight and greater
Advantage 80 mg Spot On Solution for Large Cats and Pet Rabbits
1 x 0.8 ml
Maximum of 20
Cats & Pet Rabbits of less than 4 kg body weight should receive 1 tube of the appropriate Advantage product.
Cats of 4 kg body weight and greater should receive 1 tube Advantage 80 mg Spot-On Solution for Large Cats & Pet Rabbits.
Rabbit
Product
Number of Tubes
mg/kg bw
Adult (greater than 10 weeks) less than 4 kg body weight
Advantage 40 mg Spot- On Solution for Small Cats, Small Dogs and Pet Rabbits
1 x 0.4 ml
Minimum of 10
Rabbits of 4 kg body weight and greater should receive 1 tube Advantage 80 mg Spot-On Solution for Large Cats & Pet Rabbits
Method of administration
Remove one tube from the package. Hold tube in an upright position, twist and pull off cap. Use reversed cap to twist and remove seal from tube.
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Administration to the cat
Part the hair on the cat's neck at the base of the skull until the skin is visible. Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin.
Description: {5D40CA2A-3D12-474E-8AD2-D2968974591E}
Administration to the Rabbit
Part the hair on the rabbit’s neck at the base of the skull until the skin is visible. Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin.
Description: {76803507-11D1-4D25-B615-CFF0B11447E2}
All Species
Correct application will minimise the opportunity for the animal to lick off the product. Apply only to undamaged skin. Do not allow recently treated animals to groom each other.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In cats, no adverse clinical signs were produced using doses of five times the therapeutic level weekly for eight consecutive weeks.
In rabbits, no adverse clinical signs were seen using doses of up to 45 mg/kg body weight (4 times the therapeutic level) weekly for 4 consecutive weeks.
In rare cases of overdose or licking of treated fur, nervous system disorders (such as twitching, tremors, ataxia, mydriasis, miosis, lethargy) can occur, in cats. Poisoning following inadvertent oral uptake in animals is unlikely. In this event, treatment should be symptomatic – under veterinary medical attention. There is no known specific antidote but administration of activated charcoal may be beneficial.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Do not use on rabbits intended for human consumption.