Animal Health Division
Bayer House, Strawberry Hill,
Berkshire RG14 1JA
Incorporating the data sheets for the following products:
Advantix Spot-On Solution for dogs, up to 4 kg
Advantix Spot-On Solution for dogs, of 4 kg up to 10 kg
Advantix Spot-On Solution for dogs, of 10 kg up to 25 kg
Advantix Spot-On Solution for dogs, of 25 kg and over
A clear yellowish to brownish, non-aqueous solution containing imidacloprid and permethrin. The product is presented
in a single use plastic tube for dermal (spot-on) treatment in dogs. Each tube 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
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,
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.
One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus papatasi
for two weeks and
for three weeks), against mosquitoes (Aedes aegypti
for two weeks and Culex pipiens
four weeks) and against stable flies (Stomoxys calcitrans
) for four weeks.
Dosage and administration
Please refer to Table 1.
TABLE 1Dosage and Treatment Schedule
The recommended minimum dose is:10 mg/kg bodyweight (bw) imidacloprid and 50 mg/kg bw 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 duration of activity may be reduced. In these cases do not re-treat
more frequently than once weekly. If the dog requires shampooing, it is better to do so before applying Advantix or at
least two weeks after application so as to ensure satisfactory 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. See
Administration to dogs weighing under 10 kg
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. See figure 2.
Figure 2: Administration to dogs under 10kg
Administration to dogs weighing 10 kg and over
With the dog in a standing position, the entire contents of the Advantix® pipette(s) should be applied evenly to four
spots on the midline 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
Figure 3: Administration to dogs 10kg and over
The dog should be standing for easy application.
For dermal use only. Apply only to undamaged skin.
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.
Each product also has a minimum weight limit:
Advantix® Spot-on solution- for dogs up to 4 kg
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
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 rare occasions, reactions in dogs may include transient skin sensitivity (including increased pruritus, alopecia and
erythema 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
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.
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 human 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
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, eg in the evening after children have gone to bed. In this case, recently
treated dogs should not be allowed to sleep together with their owner, especially children.
After use, replace cap on tube. Any unused product or waste material should be disposed of in accordance with
Advantix® Spot-on 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. Do not, under any circumstances, allow treated dogs
to enter any type of surface water, such as ponds, for at least 48 hours after treatment.
Permethrin containing products are toxic to honey bees.
Do not freeze.
After opening the foil pouch do not store above 30°C.
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
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
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
Marketing authorisation number
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Case 0:04-cv-03500-MJD-SRN Document 128-2 Filed 04/24/2008 Page 1 of 31and for minor J.S., Alan and Laurissa Chilson,Leigh Ann Engh, Darcene and Greg Lensing, SECOND AMENDED CLASS ACTION COMPLAINT JURY TRIAL DEMANDED I. INTRODUCTION Plaintiffs bring this action, pursuant to Rule 23 of the Federal Rules of CivilProcedure, individually and as representatives of a class of individu