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Date: Wednesday, April 17, 2024 21:57

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.35
Advantix Spot-on solution for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Imidacloprid, Permethrin
Product:Advantix Spot-on solution for dogs
Product index: Advantix Spot-on solution for dogs
Incorporating:Advantix Spot-on solution for dogs up to 4 kg
Advantix Spot-on solution for dogs over 4 kg up to 10 kg
Advantix Spot-on solution for dogs over 10 kg up to 25 kg
Advantix Spot-on solution for dogs over 25 kg up to 40 kg
Qualitative and quantitative composition
Each pipette contains:
Pipette
Active substances
Excipient(s)
Imidacloprid
Permethrin (40/60)
N-methyl
pyrrolidone
Butylhydroxytoluene (E321)
Advantix Spot-on solution for dogs up to 4 kg
0.4 ml
40.0 mg
200.0 mg
194 mg
0.4 mg
Advantix Spot-on solution for dogs over 4 kg up to 10 kg
1.0 ml
100.0 mg
500.0 mg
484 mg
1.0 mg
Advantix Spot-on solution for dogs over 10 kg up to 25 kg
2.5ml
250.0 mg
1250.0 mg
1210 mg
2.5 mg
Advantix Spot-on solution for dogs over 25 kg up to 40 kg
4.0 ml
400.0 mg
2000.0 mg
1936 mg
4.0 mg
For dogs more than 40 kg the appropriate combination with other sized pipettes should be used.
Pharmaceutical form
Spot-on solution
Clear yellowish to brownish solution
Clinical particulars
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 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 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 persistent acaricidal and repellent efficacy against tick infestations (Rhipicephalus sanguineus and 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.
Reduction of the risk of infection with Leishmania infantum via transmission by sandflies (Phlebotomus perniciosus) for up to 3 weeks. The effect is indirect due to product’s activity against the vector.
Contraindications
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. 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. (Refer to section – Special precautions for use).
Special warnings for each target species
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.
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 P. perniciosus should be kept in a protected environment during the first 24 hours after the initial treatment application.
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 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.
Description: Do Not Use on Cats
This 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 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 product. Seek veterinary advice immediately if this occurs.
Consult your veterinary surgeon before using the product on sick and debilitated dogs.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
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.
Other precautions
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.
Adverse reactions (frequency and seriousness)
Application site itching and hair change (e.g. greasy fur) and vomiting were uncommonly observed in clinical studies. Other reactions like redness, inflammation and hair loss at the application site and diarrhoea were reported rarely.
On very rare occasions reactions in dogs including transient skin sensitivity (scratching and rubbing) or lethargy were reported in spontaneous (pharmacovigilance) reports. These reactions are generally self-resolving.
In very rare cases dogs may show behaviour changes (agitation, restlessness, whining or rolling), gastro-intestinal symptoms (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).
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.
Amounts to be administered and administration route
The recommended minimum dose is:
10 mg/kg body weight (bw) imidacloprid and 50 mg/kg body weight (bw) permethrin.
Dosing Scheme for Advantix Spot-on:
Dogs
(kg body weight)
Trade name
Volume
(ml)
Imidacloprid
(mg/kg body weight)
Permethrin
(mg/kg body weight)
≤ 4 kg
Advantix Spot-on for dogs up to 4 kg
0.4 ml
minimum of 10
minimum of 50
>4 kg ≤ 10 kg
Advantix Spot-on for dogs over 4 kg up to 10 kg
1.0 ml
10 - 25
50 - 125
>10 kg ≤ 25 kg
Advantix Spot-on for dogs over 10 kg up to 25 kg
2.5 ml
10 - 25
50 - 125
>25 kg ≤ 40 kg
Advantix Spot-on for dogs over 25 kg up to 40 kg
4.0 ml
10 - 16
50 - 80
>40 kg
The appropriate combination of pipettes should be used
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 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.
To protect a dog over the whole sand fly season, treatment should be compliantly continued throughout.
For dermal use only. Apply only to undamaged skin.
Method for administration for short-neck tubes
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.
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.
Description: short neck 300
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 Advantix 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.
Description: small dog 300
Description: big dog 300
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 product.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
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.
Pharmacodynamic properties
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 provides repellent activity (anti-feeding activity) against Phlebotomus perniciosus (> 80% for 3 weeks), mosquitoes and ticks. Field data from an endemic area showed that the product indirectly reduces the risk of transmission of Leishmania infantum from infected sandflies (Phlebotomus perniciosus) for up to 3 weeks, thereby reducing the risk of canine leishmaniosis in treated dogs.
Pharmacokinetic particulars
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.
Environmental properties
The product should not be allowed to enter water courses as this may be dangerous for fish and aquatic organisms. For treated dogs, please see section Special precautions for use.
Permethrin containing products are toxic to honey bees.
Pharmaceutical particulars
List of excipients
Butylhydroxytoluene (E321)
N-Methylpyrrolidone
Miglyol 812
Citric acid (E330)
Major incompatibilities
None known.
Shelf life
Blistered tubes in pouch
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 content of the pipette has to be applied to the animal’s skin.
Special precautions for storage
Do not freeze.
After opening the foil pouch store in a dry place at a temperature not above 30°C.
Nature and composition of immediate packaging
Fill volume:
Fill Volume
imidacloprid (mg)
permethrin (mg)
Advantix Spot-on solution for dogs up to 4 kg
0.4 ml clear yellowish to brownish, non-aqueous solution per 1 ml pipette
40
200
Advantix Spot-on solution for dogs over 4 kg up to 10 kg
1.0 ml clear yellowish to brownish, non-aqueous solution per 1 ml pipette
100
500
Advantix Spot-on solution for dogs over 10 kg up to 25 kg
2.5 ml clear yellowish to brownish, non-aqueous solution per 2.5 ml pipette
250
1250
Advantix Spot-on solution for dogs over 25 kg up to 40 kg
4.0 ml clear yellowish to brownish, non-aqueous solution per 4 ml pipette
400
2000
Type of the container:
White polypropylene pipette.
White polypropylene cap.
Material of the secondary packaging:
Polychlorotrifluoroethylene PCTFE/PVC heat sealed blister packs in one or more aluminium pouch(es) and a cardboard box.
Package sizes:
Packs containing 1, 2, 3, 4, 6 and 24 unit dose pipettes. Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Advantix Spot-on solution for dogs up to 4 kg: 00879/4111
Advantix Spot-on solution for dogs over 4 kg up to 10 kg: 00879/4109
Advantix Spot-on solution for dogs over 10 kg up to 25 kg: 00879/4107
Advantix Spot-on solution for dogs over 25 kg up to 40 kg: 00879/4108
Significant changes
Date of the first authorisation or date of renewal
23 December 2003
Date of revision of the text
March 2024
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Advantix Spot-on solution for dogs up to 4 kg
GTIN:4007221047773
GTIN description:Advantix Spot-on solution for dogs over 4 kg up to 10 kg
GTIN:4007221047766
GTIN description:Advantix Spot-on solution for dogs over 10 kg up to 25 kg
GTIN:4007221047780
GTIN description:Advantix Spot-on solution for dogs over 25 kg up to 40 kg
GTIN:4007221047797