Advantage 400 dog 25-40 kg 4x4.0 ml pipettes

Advantage 400 spot-on is a flea treatment product that is suitable for the treatment of fleas, flea larvae and biting lice in dogs. The active ingredient in Advantage is imidacloprid. The content of the Advantage pipette can easily be administered on the intact skin between the shoulder blades. In dogs over 25 kg, it is advised to divide the content of the pipette evenly over 3 to 4 places on the back. The existing fleas on the dog are killed within one day after application of the product. Treatment with Advantage protects your dog 4 weeks against other flea infestations. Advantage is well suited for the treatment of dogs with flea allergy.

Tip: Don't forget to treat your house against fleas also. Only 5% of the fleas can be found on your pet. The other 95% reside in the environment. Therefore, it is important to simultaneously treat both all your pets and you house itself to deal with the flea infestation. Your house can be treated best by the combination of vacuuming and the use of a spray.

SUMMARY OF PRODUCT CHARACTERISTICS

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Advantage 400 Spot-on solution for Dogs

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Imidacloprid400 mg/pipette (4.0 ml of a 10 % solution)

Excipient(s):Butylhydroxytoluene (E 321)4.0 mg/pipette

For a full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Spot-on solutionClear yellow to slightly brownish solution

4.CLINICAL PARTICULARS

4.1Target speciesDogs

4.2Indications 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 of 25 kg body weight and greater.For dogs less than 25 kg body weight, use the appropriate Advantage forDogs product (see section 4.9).

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.

4.3Contraindications

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

4.4Special warnings

None.

4.5 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.Special precautions to be taken by the person administering the veterinary medicinal product to animalsWash hands thoroughly after use.Washoff 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.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.

4.6Adverse 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 disap-pears  within  some  minutes  without  treatment  (see  also  section  4.9 Amounts  to  be administered and administration route).In 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.

4.7Use 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.

4.8Interaction 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.

4.9Amounts to be administered and administration route

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 in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended. 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 environ-ment. 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.

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.

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.

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.

4.10Overdose (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 veterinarymedical attention. There is no known specific antidote but administration of activated charcoal may be beneficial.

4.11Withdrawal period(s)

Not applicable.

5.PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antiparasitic products, insecticides and repellents

ATCvet code: QP53AX17

5.1Pharmacodynamic properties 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.

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.

5.2Pharmacokinetic particulars

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.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Butylhydroxytoluene E321

Benzyl alcohol

Propylene carbonate

6.2Incompatibilities

None known.

6.3Shelf life

Shelf life of the veterinary medicinal product as packaged for sale

5 years

6.4Special precautions for storage

No special precautions required.

Store away from food, drink and animal feeding stuffs.

6.5Nature and composition of immediate packaging

Pack sizes4.0 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.

6.6Special 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.

7.MARKETING AUTHORISATION HOLDER

Bayer plc

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

8.MARKETING AUTHORISATION NUMBER

Vm 00010/4165

9.DATE OF FIRST AUTHORISATION25

January 1999

10.DATE OF REVISION OF THE TEXT

January 2018