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Date: Tuesday, April 16, 2024 2:02

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.48
Advantage Spot-on Solution for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Imidacloprid
Product:Advantage Spot-on Solution for Dogs
Product index: Advantage Spot-on Solution for Dogs
Incorporating:Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits
Advantage 100 Spot-on Solution for Dogs
Advantage 250 Spot-on Solution for Dogs
Advantage 400 Spot-on Solution for Dogs
Qualitative and quantitative composition
Active Substance
Imidacloprid mg per pipette
Imidacloprid ml of a 10% w/v solution
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits
40 mg
0.4 ml
Advantage 100 Spot-on Solution for Dogs
100 mg
1.0 ml
Advantage 250 Spot-on Solution for Dogs
250 mg
2.5 ml
Advantage 400 Spot-on Solution for Dogs
400 mg
4 ml
For a full list of excipients, see section Pharmaceutical particulars
Pharmaceutical form
Spot-on solution
Clear yellow to slightly brownish solution
Clinical particulars
Target species
Dogs (see also Advantage Spot-on Solution for Cats and Pet Rabbits datasheet)
Indications for use, specifying the target species
For the prevention and treatment of flea infestations and for the treatment of biting lice (Trichodectes canis) on dogs.
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 the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon.
Contraindications
Do not treat unweaned puppies of less than 8 weeks of age.
Do not use in animals that are known to be hypersensitive to the active substance or any of the excipients
Special warnings
There are no special warnings required for the target species.
Apply only to undamaged skin.
Special precautions for use
Special precautions for use in animals
This product is for topical use and should not be administered orally.
Care should be taken to avoid the contents of the pipette 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 product. Prior to re-fitting the collar, the treated area should be visually assessed to ensure it is dry.
For external use only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to Imidacloprid should avoid contact with the veterinary medicinal product.
This product contains benzyl alcohol and may cause skin sensitisation or transient skin reactions (for example, irritation, tingling).
Wash hands thoroughly after use.
Wash off any skin contamination with soap and water.
People with known skin sensitivity may be particularly sensitive to this product.
Avoid contact of the product with the eyes or mouth. Do not massage the application site.
If the product gets into eyes accidentally, the eyes should be thoroughly flushed with water.
If skin or eye irritation persists, or the product is accidentally swallowed, obtain medical attention.
Do not eat, drink or smoke during application.
After application, do not stroke or groom animals until application site is dry.
Other precautions
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.
The solvent in this 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 reactions (frequency and seriousness)
The product is bitter tasting and salivation may occa­sionally occur if the dog licks the application site immediately after treatment. This is not a sign of intoxication and disap­pears within some minutes without treatment (see also section Amounts to be administered and administration route).
On very rare occasions skin reactions such as hair loss, redness, itching and skin lesions may occur. Agitation and disorientation has also been reported. Excessive salivation and nervous signs such as incoordination, tremors and depression have been reported exceptionally in dogs.
Oral ingestion may result in other gastrointestinal signs (vomiting and diarrhoea), which have been observed very rarely based on post-marketing data.
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
No primary embryo­toxic, teratogenic or reproductive toxic effects have been observed during the studies with imidacloprid on rats and rabbits. Studies on pregnant and lactating bitches 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 product at twice the recommended dose and the following commonly used veterinary products: fenthion, lufenuron, milbemycin, febantel, pyrantel and praziquantel. The compatibility of the product was also demonstrated with a wide range of routine treatments under field conditions including vaccination.
Amounts to be administered and administration route
Dosage and Treatment Schedule
Dog (kg bw)
Product
Number of Pipettes
Imidacloprid (mg/kg bw)
Less than 4 kg
Advantage 40 mg Spot-On
Solution for Small Cats, Small
Dogs and Pet Rabbits
1 x 0.4 ml
minimum of 10
4 < 10 kg
Advantage 100 for Dogs
1 x 1.0 ml
minimum of 10
10 < 25 kg
Advantage 250 for Dogs
1 x 2.5 ml
minimum of 10
25 < 40 kg
Advantage 400 for Dogs
1 x 4.0 ml
minimum of 10
more than 40 kg
Advantage 400 for Dogs
2 x 4.0 ml
minimum of 10
Treatment should be repeated after 4 weeks. Treatment of nursing bitches controls flea infestations on both dam and offspring.
Fleas are killed within one day following treatment. One treatment prevents further flea infestation on dogs for up to 4 weeks. Should re-treatment become necessary earlier than 4 weeks, do not re-treat more frequently than weekly.
Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. More than one treatment may therefore be required, depending on the level of fleas in the environment. 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.
The product remains effective if the animal becomes wet, for example after swimming or exposure to heavy rain. However, in cases of frequent swimming or bathing re-treatment may become necessary, depending on the presence of fleas in the environ­ment. In these cases do not re-treat more frequently than once weekly.
In case of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Method of Administration
Remove one pipette from the package. For dogs of 40 kg body weight and greater use two pipettes. Hold pipette in an upright position, twist and pull off cap. Use reversed cap to twist and remove seal from pipette.
Description: Advocate dog image one pipette
For dogs less than 25 kg body weight:
With the dog in the 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.
Description: Advocate dog image two scruff
For dogs of 25 kg body weight and greater:
The dog should be standing for easy application. The entire contents of the pipette(s) should be applied evenly to three or four spots all located at different application sites along the dog’s backline from the shoulder to the base of the tail. At each spot part the coat until the skin is visible.
Description: Advocate dog image three 123
Place the tip of the pipette on the skin and gently squeeze to expel a portion of the contents directly onto the skin.
For all dogs:
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.
The product is bitter tasting and salivation may occa­sionally occur if the dog licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct applica­tion will minimize the opportunity for the dog to lick the product.
Apply only to undamaged skin. Do not allow recently treated animals to groom each other.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse clinical signs were produced by either individual doses of up to 200 mg/kg body weight (five to eight times the therapeutic dose), daily treatments at 100 mg/kg body weight for five consecutive days or weekly treatments at five times the maximum dose rate for eight 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.
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.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic products, insecticides and repellents
ATCvet code: QP53AX17
Pharmacodynamic properties
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine* is an ectoparasiticide belonging to a new group of chloronicotinyl compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.
The substance has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS). The ensuing inhibition of cholinergic transmission in in­sects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptor sites and the postulated poor penetration through the blood/brain barrier in mammals, it has virtually no effect on the mam­malian CNS. The minimal pharmacological activity in mammals is supported by safety studies involving systemic administration of sub-lethal doses to rabbits, mice and rats.
In further studies, 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 pet’s surroundings are killed following contact with a treated animal.
Pharmacokinetic particulars
Oral studies in the rat show imidacloprid to be absorbed rapidly from the gastro-intestinal tract. Almost complete absorption (95%) occurs within 48 hours. Peak plasma concentrations are observed within 2.5 hours following administration. Tissue distribution is also rapid with the lowest levels recorded in the brain. The active ingredient undergoes extensive metabolism with only 10-16% remaining as parent compound. Almost complete (96%) elimination occurs within 48 hours, approximately 75% being removed by the kidneys and 21% with the faeces.
The product is indicated for cutaneous administration. Following topical application in dogs, the solution is quickly distributed over the animal. Acute dermal studies in the rat and target animal overdose and serum kinetic studies have established that systemic absorption is very low, transient and not relevant for the clinical efficacy. This has been further demonstrated by a study in which fleas were not killed after having fed on previously treated animals once the animal’s skin and fur had been cleaned of all active material.
Pharmaceutical particulars
List of excipients
Butylhydroxytoluene E321
Benzyl alcohol
Propylene carbonate
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale 5 years
Special precautions for storage
No special precautions required.
Store away from food, drink and animal feeding stuffs.
Nature and composition of immediate packaging
Pack sizes 4.0 ml solution per pipette
Pack containing 1, 2, 3, 4, or 6 unit dose pipettes
Container White polypropylene pipettes with caps
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
Any unused product or waste materials should be disposed of in accordance with national requirements. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty containers.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits: Vm 00879/4100
Advantage 100 Spot-on Solution for Dogs: Vm 00879/4097
Advantage 250 Spot-on Solution for Dogs: Vm 00879/4098
Advantage 400 Spot-on Solution for Dogs: Vm 00879/4103
Significant changes
Date of the first authorisation or date of renewal
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits: 14 August 2001
Advantage 100 and 250 Spot-on Solution for Dogs: 17 March 1997
Advantage 400 Spot-on Solution for Dogs: 25 January 1999
Date of revision of the text
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits: December 2021
Advantage 100, 250 and 400 mg Spot-on Solution Dogs: October 2020
Any other information
Legal category
Legal category: NFA-VPS
GTIN
GTIN description:Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits x 4 pack
GTIN:4007221046844
GTIN description:Advantage 100 Spot-on Solution for Dogs x 4 pack
GTIN:4007221046837
GTIN description:Advantage 250 Spot-on Solution for Dogs x 4 pack
GTIN:4007221046851
GTIN description:Advantage 400 Spot-on Solution for Dogs x 4 pack
GTIN:4007221046868