Advantix dog

Advantix Spot-On is an anti-flea remedy for dogs and contains the active ingredients imidacloprid and permethrin. Due to the combination of these active ingredients, Advantix is not only suitable for combating fleas, ticks, and biting lice, but also has a repellent effect against sandflies, mosquitoes, and stable flies. Due to the repellent effect, the mentioned parasites have no chance to bite your dog, reducing the risk of transmission of diseases such as Leishmania, Ehrlichia, Babesia, heartworm disease (Dirofilaria), and Lyme disease significantly.

Operation

Advantix kills fleas within 24 hours and protects your dog for 4 weeks against new fleas. Advantix is highly suitable for treating dogs with flea allergy. Advantix protects for 4 weeks against ticks (3 weeks against Dermacentor reticulatus), 2-3 weeks against sandflies, 2-4 weeks against mosquitoes, and 4 weeks against stable flies.

Application

The contents of the pipette should be applied between the shoulder blades. Spread the fur so that you apply the contents of the pipette directly to the skin. The Advantix will then distribute over the rest of the body via the sebum layer of the skin. For dogs weighing more than 10 kg, it is recommended to divide the contents of the pipette over 4 spots along the back (from the shoulder blades to the base of the tail). Advantix is available in packs of 4 or 6 pipettes.

Dosage

Leaflet

Read the leaflet before use.

Use during pregnancy, lactation and in puppies

Advantix can be used in pregnant or lactating dogs. Advantix should not be used in puppies less than 7 weeks, dogs weighing less than 1.5 kg, cats and hypersensitivity to one of its ingredients.

Adverse reactions

Transient cutaneous reactions such as hair loss, redness and itching can be seen in rare cases. In very rare cases, behavioural changes, gastro-intestinal symptoms or neurological symptoms can occur. These symptoms are usually transient and disappear by itself.

Instructions

             spot-on solution

1. NAME AND ADDRESS OF THE AUTHORIZATION OF THE HOLDER ON THE MARKET AND THE MANUFACTURER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Holder of the authorization for marketing:

Bayer B.V.

Animal Health Division 

Energieweg 1

NL-3641 RT Mijdrecht

Manufacturer for batch release:

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324, D-24106 Kiel

Duitsland 

2.   NAME OF THE VETERINARY MEDICINAL

Advantix^® 40/200 spot-on solution for dogs

Advantix^® 100/500 spot-on solution for dogs

Advantix^® 250/1250 spot-on solution for dogs

Advantix^® 400/2000 spot-on solution for dogs

3. STATEMENT OF ACTIVE AND OTHER INGREDIENTS

Per ml:

Active ingredients: 

Imidacloprid: 100 mg

               Permethrine:   500 mg

Excipients: 

Butylhydroxytolueen (E321): 1,0 mg

Every pipet contains: 

                  For dogs> 40 kg should be used the appropriate combination of pipettes

 4.     INDICATIONS

For the treatment, the prevention of a flee infestation (C. canis, C. felis) and for the treatment of biting lice (Trichodectes canis) in dogs.

Fleas on dogs are slain within one day following treatment. A single treatment prevents further fleeinfestation for four weeks. The veterinary medicinal product can be used as a part of a treatment strategy for flea allergy dermatitis (FAD).

The veterinary medicinal product has persistent acaricidal and repellent efficacy against tick infestations (R. sanguineus and I. ricinus and D. reticulatus for four weeks for three weeks).

It may happen that ticks already on the dog were not slain within two days after treatment and may remain attached and visible. It is therefore recommended to sign already on removing the dog sit at the time of treatment, to prevent them as to attach themselves and to take a blood meal.

One treatment provides repellent (anti-feeding) activity against sand flies (P. papatasi for two weeks and P. perniciosus for three weeks), against mosquitoes (A. aegypti and C. pipiens for two weeks for four weeks) and against stable flies (S. calcitrans) for four weeks.

 5.      CONTRA-INDICATIONS

In the absence of available data, the veterinary medicinal product should not be used on puppies less than 7 weeks, or 1.5 kg of body weight. Depending on the body weight of the dog is the corresponding Advantix® product to be used, see dosing schedule.

Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use on cats.

6.   SIDE EFFECTS

In very rare cases, the dog may experience reactions such as transient skin hypersensitivity (increased local itching, scratching, rubbing, hair loss and redness at the injection site) or lethargy, which usually disappear by themselves.

In very rare cases, dogs can behavioral changes (agitation, restlessness, whine or roll), gastrointestinal symptoms (vomiting, diarrhea, hypersalivation, loss of appetite) and neurological symptoms, such as irregular movements and muscle tremors in dogs that are sensitive to the ingredient permethrin . These effects are usually transient and usually disappear by themselves.

Intoxication by inadvertent oral ingestion by dogs is unlikely but may occur in very rare cases. In this case, neurological symptoms such as tremors and apathy occur. Treatment should be symptomatic. There is no specific antidote available. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

 7.   SPECIES (S) THE VETERINARY MEDICINAL IS DESTINED FOR

Dog.

8.  DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S)

The recommended minimum dose is:

                                   10 mg / kg body weight (bw) imidacloprid and 50 mg / kg body weight (bw) permethrin.

           Dose:

                  For dogs> 40 kg should be used the appropriate combination of pipettes

To re-introduction by reducing the emergence of new fleas it is recommended to treat all dogs in the household. Other animals living in the same household, should also be treated with a suitable animal medicine.

To further assist in reducing the load from the environment, the additional use of a suitable environment in treatment against adult fleas and their developmental stages is recommended.

The veterinary medicinal product remains effective if the animal becomes wet. However, prolonged intensive exposure to water should be avoided. In cases of frequent exposure to water could be reduced, the persistent efficacy. In those cases, no more frequently than once per week retreatment. If the dog requires a wash turn, this would be better for the treatment carried out with the veterinary medicinal or at least two weeks after administration, in order to keep the efficacy of the veterinary medicinal optimal.
 

Upon biting lice infestation, control is recommended by the veterinarian 30 days after treatment, as some animals, a second treatment may be necessary.

Method of apply

Take a pipet from the package. Hold the pipette in upright position, twist and pull off cap. Raise the cap reversed again, turn to break the seal and remove the cap again.

For dogs till 10 kg body weight:

While the dog is standing hair pressures between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty the contents directly onto the skin.

For dogs up to 10 kg body weight:

While the dog is stationary, the entire contents of the pipette Advantix® evenly at four sites on the back of shoulder fitting to tail base. At each spot aside the coat until the skin is visible. Place the tip of the pipette on the skin and gently squeeze to expel a portion of its contents directly onto the skin.

9.   ADVICE ON CORRECT APPLY

For external use only.

Apply only to undamaged skin.

Spend too much on a single seat; otherwise can run off a portion of the solution from the side of the dog.
 

10. WAITING PERIOD

not applicable.

11.  SPECIAL STORAGE

Keep out of the sight and reach of children. Do not freeze.

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

Use within 24 months after opening the foil pouch or before EXP, the shorter of the two.

Do not use after the expiry date stated after EXP on the pipette, the aluminum pouch or box.
 

12.     SPECIAL WARNINGS

Special precautions for use in animals
 

It must ensure that the contents of the pipette do not come into contact with the eyes or mouth of the dog being treated.

One should ensure that the veterinary medicinal product is administered properly, as described under Method of administration.

In particular, oral ingestion by the lick at the application site by treated dogs or by animals that come into in contact with it, to be avoided.

Do not use on cats.

This veterinary medicinal product is extremely toxic to cats and could be fatal due to the specific physiology of cats, which can not break some compounds such as permethrin . Keep treated dogs away from cats until the application site is dry, to prevent cats are accidentally exposed to this animal medicine. It is important to ensure that cats do not lick the application site of a dog that has been treated with this veterinary medicinal product. Seek immediate veterinary drugs-professional advice if this happens.

Consult your veterinarian before using the veterinary medicinal product in sick and debilitated dogs.
 

Treated dogs should be allowed under any circumstance to surface for at least 48 hours after treatment, because the veterinary medicinal product is damaging to aquatic organisms.

Special precautions to be taken by the person administering the product to animals
 

Avoid contact with the veterinary medicinal product with 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 immediately with soap and water.

People with known skin sensitivity may be particularly sensitive to this veterinary medicinal product. The main clinical symptoms that could occur in extremely rare cases, sensory irritation transient, such as tingling, burning or numbness. If the veterinary medicinal product accidentally gets into the eyes, rinse thoroughly with water. If skin or eye irritation persists, or if the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package insert.

Treated dogs should not be used by children in particular until the application site is dry. This could be ensured by the animals for example. To be treated in the evening. Recently treated dogs should not teslapen with owners, especially children.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

After use the cap back on the pipette.

Any unused veterinary medicinal products or waste material should be disposed of in accordance with local requirements.

14.      DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED

 15.  OTHER INFORMATION

The veterinary medicinal product is contains an ectoparasiticide for topical use imidacloprid and permethrin. This combination works as an insecticide, acaricide and as a repellent.

Imidacloprid is effective against adult fleas and larval flea stages. In addition to the adulticide flea efficacy through imidacloprid was also shown a larvicide efficacy against fleas in the environment of the treated pet. Larval stages are slain in the immediate vicinity of the dog after contact with a treated animal.

The veterinary medicinal product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing the repelled parasites take a blood meal and thus reduces the risk of Canine Vector-Borne Disease (CVBD) transfer (diseases such as Borreliosis, Rickettsiosis , Ehrlichiosis, Leishmaniosis).

An attachment of individual character or individual bites of sand flies or mosquitoes could occur, however. For these reasons, a transmission of infectious diseases by these parasites can not be completely excluded if conditions are unfavorable.

The veterinary medicinal product can be used during pregnancy and lactation.

The solvent in Advantix® spot-on solution could spot various materials including leather, fabric, plastic and delicate surfaces. Allow the application site to dry before contact is allowed with such surfaces.

Pack sizes: 0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette; boxes with multiples of blisters of 1, 4, 6 pipettes for single use only.

It may happen that not all pack sizes may be on the marketed.
 

PROHIBITION
Free

REG NL 106415