Advantix

Main information

  • Trade name:
  • Advantix Spot-on Solution for Dogs over 40 kg up to 60 kg
  • Pharmaceutical form:
  • Spot-on solution
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Advantix Spot-on Solution for Dogs over 40 kg up to 60 kg
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Dogs
  • Therapeutic area:
  • Ectoparasiticide

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 00010/4215
  • Authorization date:
  • 28-11-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Issued: November 2017

AN: 01248/2016

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Advantix Spot-on solution for dogs over 40 kg up to 60 kg

[AT, CZ, DE, EL, HU, IE, IT, NL, PT, SK, ES, UK]

Advantix tres grand chien [FR]

Bayvantic vet spot-on solution for dogs over 40 kg up to 60 kg

[DK, FI, NO]

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pipette of 6.0 ml contains:

Active substances:

Imidacloprid:

600.0 mg

Permethrin (40/60):

3000.0 mg

Excipient(s):

Butylhydroxytoluene (E321): 6.0 mg

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Spot-on solution

Clear yellowish to brownish solution

4.

CLINICAL PARTICULARS

4.1

Target species

Dogs (over 40 kg up to 60 kg)

For dogs less than or equal to 40 kg or more than 60 kg body weight, use the

appropriate Advantix Spot-on solution product or combination of products (see

section 4.9).

4.2

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).

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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.

4.3

Contraindications

In the absence of available data the product should not be used on puppies of less

than 7 weeks of age or 40 kg of weight.

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 4.5 – Special precautions for use).

4.4

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.

4.5

Special precautions for use

i)

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

4.9. In particular oral uptake due to the licking of the application site by treated or in-

contact animals should be avoided.

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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.

ii) 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, seek medical advice immediately and show

the package leaflet or the label 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.

iii)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.

4.6

Adverse reactions (frequency and seriousness)

On very rare occasions reactions in dogs may include transient skin sensitivity

(increased local itching, scratching and rubbing, hair loss and redness at the

application site) or lethargy that are generally self-resolving.

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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 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).

4.7

Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8

Interaction with other medicinal products and other forms of interaction

None known.

4.9

Amounts to be administered and administration route

For dermal use only. Apply only to undamaged skin.

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)

>40 kg

Advantix Spot-on for

dogs over 40 kg up to

60 kg

6.0 ml

10 - 15

50- 75

For dogs > 60 kg the appropriate combination with other sized 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.

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AN: 01248/2016

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.

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.

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.

4.10 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.

4.11 Withdrawal period(s)

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

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.

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AN: 01248/2016

5.1

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.

5.2

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.

5.3

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 4.5.

Permethrin containing products are toxic to honey bees.

6.

PHARMACEUTICAL PARTICULARS

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6.1

List of excipients

Butylhydroxytoluene (E321)

N-Methylpyrrolidone

Triglycerides, medium-chain

Citric acid (E330; for pH adjustment)

6.2

Major incompatibilities

None known.

6.3

Shelf life

Shelf-life of product in foil pouch:

3 years.

Shelf life of product after opening foil

pouch:

12 months

(all pipettes should be used within 12

months after opening the foil pouch or

before expiry date on the pipette

whichever is shorter).

Shelf-life of the broached pipette:

Once opened, the entire contents of the

pipette has to be applied to the animal’s

skin.

6.4

Special precautions for storage

Do not freeze.

After opening the foil pouch store in a dry place at a temperature not above 30°C.

6.5

Nature and composition of immediate packaging

Fill volume:

6.0 ml

Type of the container:

White polypropylene pipette.

White polypropylene cap.

Material of the secondary

packaging:

Polychlorotrifluoroethylene PCTFE/PVC or 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.

6.6

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.

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The product should not enter water courses as this may be dangerous for fish and

other aquatic organisms.

7.

MARKETING AUTHORISATION HOLDER

Bayer plc

400 South Oak Way

Green Park

Reading

Berkshire

RG2 6AD

8.

MARKETING AUTHORISATION NUMBER

Vm 00010/4215

9.

DATE OF FIRST AUTHORISATION

28 November 2017

10.

DATE OF REVISION OF THE TEXT

November 2017

Approved: 28/11/2017

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