ADVANTIX SPOT-ON

ADVANTIX SPOT-ON

NAME OF THE MEDICINAL PRODUCT

Advantix Spot-on for Dogs from 4 kg to 10 kg

ACTIVE PRINCIPLE

each pipette contains:

Advantix Spot-on for dogs ≤ 4 kg: 0.4 ml; Imidacloprid: 40 mg; Permethrin: 200 mg; Butylhydroxytoluene (E321): 0.4 mg

Advantix Spot-on for dogs> 4 ≤ 10 kg: 1.0 ml; Imidacloprid: 100 mg; Permethrin: 500 mg; Butylhydroxytoluene (E321): 1.0 mg

Advantix Spot-on for dogs> 10 ≤ 25 kg: 2.5 ml; Imidacloprid: 250 mg; Permethrin: 1250 mg; Butylhydroxytoluene (E321): 2.5 mg

Advantix Spot-on for dogs> 25 ≤ 40 kg: 4.0 ml; Imidacloprid: 400 mg; Permethrin: 2000 mg: Butylhydroxytoluene (E321): 4.0 mg

Advantix Spot-on for dogs> 40 kg ≤ 60 kg: 6.0 ml; Imidacloprid: 600 mg; Permethrin: 3000 mg: Butylhydroxytoluene (E321): 6., 0 mg

For dogs> 60 kg the appropriate combination with other size pipettes should be used.

QUALITATIVE AND QUANTITATIVE COMPOSITION

PHARMACEUTICAL FORM

solution

CLINICAL INFORMATION

Therapeutic indications

for the treatment and prevention of flea infestations (C. canis, C. felis) and for the treatment of louse (Trichodectes canis) in dogs. Fleas on dogs are killed within one day of 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). 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). Through its repellent and killing action on the vector tick Rhipicephalus sanguineus, the product reduces the probability of transmission of the pathogen Erlichia canis, thus reducing the risk of canine ehrlichiosis. The risk reduction has been demonstrated in studies starting on day 3 after application of the product and persists for 4 weeks. Ticks already present on the dog may not be killed within two days after treatment and may remain attached and visible. It is therefore recommended to remove ticks already present on the dog at the time of treatment, in order to prevent them from latching on and consuming 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 for two weeks and C. pipiens for four weeks) and against horseflies (S. calcitrans) for four weeks. Reduction of the risk of infection with Leishmania infantum through transmission from sand flies (Phlebotomus perniciosus) for up to 3 weeks. The effect is indirectly determined by the activity of the product against the vector.

Phlebotomas: P. perniciosus 3 weeks; P. papatasi 2 weeks

Mosquitoes: A. aegypti 2 weeks; C. pipiens 4 weeks

Horse fly: S. calcitrans 4 weeks

Posology and method of administration

the minimum recommended dose is 10 mg / kg of body weight (bw) of imidacloprid and 50 mg / kg of body weight (bw) of permethrin.

Dosage schedule:

Dogs (kg pc): 4 kg or less; Advantix Spot-on for dogs up to 4 kg; volume: 0.4ml; imidacloprid (mg / kg bw): minimum 10; permethrin: (mg / kg bw): minimum 50

Dogs (kg pc): over 4 kg and up to 10 kg; Advantix Spot-on for dogs over 4 kg up to 10 kg; volume 1.0 ml; imidacloprid (mg / kg bw): 10-25; permethrin (mg / kg bw): 50-125

Dogs (kg pc): over 10 kg and up to 25 kg; Advantix Spot-on for dogs over 10 kg up to 25 kg; volume 2.5 ml; imidacloprid (mg / kg bw): 10-25; permethrin (mg / kg bw): 50-125

Dogs (kg pc): over 25 kg and up to 40 kg; Advantix Spot-on for dogs over 25 kg up to 40 kg; volume 4.0 ml; imidacloprid (mg / kg bw): 10-16; permethrin (mg / kg bw): 50-80

Dogs (kg pc): over 40 kg and up to 60 kg; Advantix Spot-on for dogs over 40 kg up to 60 kg; volume 6.0 ml; imidacloprid (mg / kg bw): 10-15; permethrin (mg / kg bw): 50-75

For dogs> 60 kg the appropriate combination with other size pipettes should be used.

To reduce re-infestation due to the appearance of new fleas, it is recommended to treat all dogs in the home. Other animals living in the same domestic environment must be treated with a suitable product. To further help reduce the environmental threat, the additional use of appropriate environmental treatment against adult fleas and their developing stages is recommended. The product remains effective if the animal gets wet. However, prolonged and intense exposure to water should be avoided. In case of frequent exposure to water the persistence of efficacy can be reduced. In these cases, do not repeat the treatment more frequently than once a week. If a shampoo is required for the dog, it is best to do this before applying Advantix or at least two weeks after application, to optimize the effectiveness of the product. In the event of a lice infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.To protect a dog throughout the sand flies season, treatment should be continued as appropriate for all time

Method of administration: Remove a pipette from the package. Holding the pipette upright, twist and remove the cap. Turn the cap back over and put the opposite end back onto the pipette. Twist the cap to break the seal and then remove the cap from the pipette.

For dogs up to 10 kg of body weight: with the dog still on all fours, divide 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 until the contents are emptied directly onto the skin.

For dogs over 10 kg body weight: with the dog stationary on all fours, all the contents of the Advantix pipette should be applied equally in four places on the top of the back starting from the shoulders to the base of the tail. At each point, divide the coat until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to empty some of the solution onto the skin.

for external use only. Apply only on intact skin. Do not apply an excessive amount of solution in any of the places that could cause a part of it to run down the sides of the dog. For external use only.

Contraindications

in the absence of available data, the product should not be used on puppies less than 7 weeks of age or 1.5 kg of weight. Depending on the dog's body weight, the corresponding Advantix product should be used. Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use on cats.

Special warnings and precautions for use

It is possible for single ticks to attack or for single sand flies or mosquitoes to bite. For this reason, if conditions are unfavorable, the transmission of infectious diseases by these parasites cannot be completely ruled out. However, the product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing repelled parasites from taking a blood meal and thus reducing the risk of transmission of vector-transmitted dog diseases ( CVBD), (diseases such as borreliosis, rickettsiosis, ehrlichiosis, leishmaniasis). It is recommended to apply the treatment at least 3 days before the anticipated exposure to E. canis. Regarding E. canis, studies have shown 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 persistent for 4 weeks.

Special precautions for use in animals: Care should be taken to administer the product correctly as described in Method of Administration. In particular, oral ingestion due to licking of the application site by treated animals or by animals in contact with them must be prevented. Do not use on cats. This product is extremely toxic to cats and could be fatal, due to the unique physiology of the cat which is unable to metabolize certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep treated dogs away from cats, after treatment and until the application site has dried. It is important to ensure that cats do not lick the application site of a dog treated with this product. infectious diseases by these parasites. However, the product provides repellent (anti-feeding) activity against ticks, sand flies and mosquitoes, thus preventing repelled parasites from taking a blood meal and thus reducing the risk of transmission of vector-transmitted dog diseases ( CVBD), (diseases such as borreliosis, rickettsiosis, ehrlichiosis, leishmaniasis) Immediate protection against sand fly bites is not documented. Dogs treated for the reduction of the risk of Leishmania infantum infection through transmission from P. perniciosus sand flies should be kept in a protected environment for the first 24 hours after application of the initial treatment. It is recommended to apply the treatment at least 3 days before the anticipated exposure to E. canis. Regarding E. canis, studies have shown 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 persistent for 4 weeks.

Special precautions for use in animals: Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of treated dogs. Care should be taken to administer the product correctly as described in Method of Administration. In particular, oral ingestion due to licking of the application site by treated animals or by animals in contact with them must be prevented. Do not use on cats. This product is extremely toxic to cats and could be fatal, due to the unique physiology of the cat which is unable to metabolize certain compounds, including permethrin. To prevent cats from being accidentally exposed to the product, keep treated dogs away from cats, after treatment and until the application site has dried. It is important to ensure that cats do not lick the application site of a dog treated with this product. If this happens, contact a veterinarian immediately. Consult your veterinarian before using the product on sick or debilitated dogs.

Side effects

on very rare occasions, dogs may experience transient skin sensitivity (increased local itching, scratching and rubbing, hair loss and redness at the application site) or lethargy which generally resolves spontaneously. In very rare cases dogs may exhibit changes in behavior (agitation, restlessness, moaning or rolling movements), gastrointestinal symptoms (vomiting, diarrhea, hypersalivation, decreased appetite) and neurological signs such as staggering and twitching in sensitive dogs. to the permethrin substance. These symptoms are usually transient and resolve spontaneously. Poisoning from inadvertent oral intake is unlikely in dogs, although this can occur in very rare cases. In this event, neurological signs such as tremors and lethargy may occur. Treatment must be symptomatic. There are no known specific antidotes. The frequency of adverse reactions is defined using the following conventions: very common (more than 1 in 10 treated animals exhibit adverse reactions during the course of one treatment); 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)

PHARMACOLOGICAL PROPERTIES

PHARMACEUTICAL INFORMATION

Excipients

each pipette contains:

Advantix Spot-on for dogs ≤ 4 kg: butylated hydroxytoluene (E321): 0.4 mg

Advantix Spot-on for dogs> 4 ≤ 10: butylated hydroxytoluene (E321): 1.0 mg

Advantix Spot-on for dogs> 10 ≤ 25 kg: butylated hydroxytoluene (E321): 2.5 mg

Advantix Spot-on for dogs> 25 ≤ 40 kg: butylated hydroxytoluene (E321): 4.0 mg.