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Date: Friday, July 19, 2024 22:16

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.52
Advantage Spot-on Solution for Cats and Pet Rabbits
 
Species: Cats, Rabbits
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For cats, For rabbits
Active ingredient: Imidacloprid
Product:Advantage Spot-on Solution for Cats and Pet Rabbits
Product index: Advantage Spot-on Solution for Cats and Pet Rabbits
Withdrawal notes: Do not use in rabbits intended for human consumption.
Incorporating:Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits
Advantage 80 mg Spot-on Solution for Large Cats & Pet Rabbits
Qualitative and quantitative composition
Active Substance
Imidacloprid mg per tube
Imidacloprid ml of a 10% w/v solution
Advantage 40 mg Spot-on Solution for Small Cats, Small Dogs and Pet Rabbits
40
0.4ml
Advantage 80 mg Spot-on Solution for Large Cats & Pet Rabbits
80
0.8 ml
For full list of excipients, see section Pharmaceutical particulars, List of excipients.
Pharmaceutical form
Spot-on solution.
Clear yellow to slightly brownish solution.
Clinical particulars
Target species
For cats and pet rabbits
For Small Dogs see datasheet: Advantage Spot-On Solution for Dogs
Indications for use, specifying the target species
For the prevention and treatment of flea infestations on cats.
For the treatment of flea infestations on pet rabbits.
Fleas are killed within one day following treatment. One treatment prevents further flea infestation for three to four weeks on cats and up to one week on pet rabbits. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) in cats where this has been previously diagnosed by a veterinary surgeon.
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 for each target species
There are no special warnings required for the target species.
Special precautions for use
i. Special precautions for use in animals
Care should be taken to avoid the contents of the tube coming into contact with the eyes or mouth of the user or 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.
ii. Special precautions to be taken by the person administering the medicinal product to animals
Wash hands thoroughly after use.
Wash off any skin contamination with soap and water.
After application do not stroke or groom animals until the application site is dry (typically within an hour or so).
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 allergy, irritation, tingling).
Avoid contact between the product and the skin, 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, obtain medical attention.
If the product is accidentally swallowed, obtain medical attention immediately.
Do not eat, drink or smoke during application.
iii. Other precautions
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.
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.
Adverse reactions (frequency and seriousness)
The product is bitter tasting and salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within a few minutes without treatment (see also section, 'Amount to be administered and administration route').
On very rare occasions skin reactions such as hair loss, redness, itching and skin lesions may occur. Agitation has also been reported. Excessive salivation and nervous signs such as incoordination, tremors and depression have been reported exceptionally in cats.
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 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 product at twice the recommended dose and the following commonly used veterinary products: lufenuron, febantel, pyrantel and praziquantel (dogs) and lufenuron, pyrantel and praziquantel (cats). The compatibility of the product was also demonstrated with a wide range of routine treatments under field conditions including vaccination.
Amount(s) to be administered and administration route
Dosage and Treatment Schedule
Cat & Pet Rabbit (kg body weight)
Product
Number of Tubes
mg/kg bw
Less than 4 kg bodyweight
Advantage 40 mg Spot-On Solution for Small Cats, Small Dogs and Pet Rabbits
1 x 0.4 ml
Minimum of 10
4 kg and greater
Advantage 80 mg Spot-On Solution for Large Cats & Pet Rabbits
1 x 0.8 ml
Maximum of 20
Treatment should be repeated after 4 weeks. Treatment of nursing queens controls flea infestations on both dam and offspring.
Fleas are killed within one day following treatment. One treatment prevents further flea infestation on cats for 3-4 weeks and on rabbits for up to one week. 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 exposure to heavy rain or after swimming. 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.
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.
Description: Advantage tube pic
Administration to the Cat
Part the hair on the cat's neck at the base of the skull until the skin is visible.
Description: Advantage cat pic
Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin.
Administration to the Rabbit
Part the hair on the rabbit’s neck at the base of the skull until the skin is visible.
Description: Advantage rabbit pic
Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cats, no adverse clinical signs were produced using doses of five times the therapeutic level 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.
Poisoning following inadvertent oral uptake in either man or animals is unlikely. In this event, treatment should be symptomatic. There is no known specific antidote but administration of activated charcoal may be beneficial.
Withdrawal period(s)
Not applicable as the veterinary medicinal product is not indicated for the treatment of food producing animals.
Do not use in rabbits intended for human consumption.
Pharmacological particulars
Ectoparasiticide for topical use: ATC VetCode: QP53AX17
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to a group of chloronicotinyl compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.
Pharmacodynamic properties
Imidacloprid 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 cat has been demonstrated. Larval stages in the cat’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 solution is indicated for cutaneous administration. Following topical application, the product 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 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
Butyl hydroxytoluene
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
This veterinary medicinal product does not require any special storage conditions.
Store away from food, drink and animal feedingstuffs.
Nature and composition of immediate packaging
Packaging style: Blister packs containing 2, 3, 4 or 6 unit dose tubes or a single unit dose tube without blister.
Pack Size: Carton contains 1 tube or 1, 5, 10 or 20 blisters each with 2, 3, 4 or 6 tubes
Container material: White polypropylene tube; White polypropylene cap
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, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local 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 80 mg Spot-on Solution for Large Cats & Pet Rabbits: Vm 00879/4105
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 80 mg Spot-on Solution for Large Cats & Pet Rabbits: 23 July 2003
Date of revision of the text
December 2021
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 80 mg Spot-on Solution for Large Cats & Pet Rabbits x 4 pack
GTIN:4007221047667