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Advocate Spot-on Solution Animal Health DivisionBayer House, Straw berry Hill,New buryBerkshire RG14 1JA Incorporating the data sheets for the follow ing products:Advocate 40 mg + 4 mg spot-on solution for smal cats and ferretsAdvocate 80 mg + 8 mg spot-on solution for large catsAdvocate 40 mg + 10 mg spot-on solution for smal dogsAdvocate 100 mg + 25 mg spot-on solution for medium dogsAdvocate 250 mg + 62.5 mg spot-on solution for large dogsAdvocate 400 mg + 100 mg spot-on solution for extra-large dogsPresentationAdvocate spot-on solution for cats and ferrets is a clear yel ow to brow nish solution containing 100 mg/ml imidacloprid and 10mg/ml moxidectin w ith benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E 321 as an antioxidant). Each pipette of the smal catand ferret presentations contains 0.4 ml (40 mg imidacloprid, 4 mg moxidectin), the large cat presentation contains 0.8 ml (80 mgimidacloprid, 8 mg moxidectin). Advocate spot-on solution for dogs is a clear yel ow to brow nish solution containing 100 mg/ml imidacloprid and 25 mg/mlmoxidectin w ith benzyl alcohol and Butylhydroxytoluene 1 mg/ml (E321 as an antioxidant). Each pipette of the dog presentationscontains either 0.4 ml (40 mg imidacloprid, 10 mg moxidectin), 1.0 ml (100 mg imidacloprid, 25 mg moxidectin), 2.5 ml (250 mgimidacloprid, 62.5 mg moxidectin) or 4.0 ml (400 mg imidacloprid, 100 mg moxidectin).
UsesFor use in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections: For cats: For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation(Otodectes cynotis), prevention of heartw orm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections w ithgastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme). The productcan be used as part of a treatment strategy for flea al ergy dermatitis (FAD).
For ferrets: For the treatment and prevention of flea infestation (Ctenocephalides felis) and the prevention of heartw ormdisease (L3 and L4 larvae of Dirofilaria immitis).
For dogs: For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of biting lice (Trichodectescanis), treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis),demodicosis (caused by Demodex canis), prevention of heartw orm disease (L3 and L4 larvae of Dirofilaria immitis) andangiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum), treatment of Angiostrongylus vasorum andCrenosoma vulpis and treatment of infections w ith gastrointestinal nematodes (L4 larvae, immature adults and adults ofToxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis). Theproduct can be used as part of a treatment strategy for flea al ergy dermatitis (FAD).
Dosage and administration Dosage schedule The recommended minimum doses for cats are 10 mg/kg body w eight imidacloprid and 1.0 mg/kg body w eight moxidectin,equivalent to 0.1ml/kg body w eight Advocate for cats. Dosage schedule for ferrets: one pipette of Advocate spot-on solution forsmal cats and ferrets (0.4 ml) should be administered per animal. Do not exceed the recommended dose. The recommendedminimum doses for dogs are 10 mg/kg body w eight imidacloprid and 2.5 mg/kg body w eight moxidectin, equivalent to 0.1ml/kgbody w eight Advocate for dogs.
The treatment schedule for al species should be based on the local epidemiological situation.
Cats (Refer to Table 1) Pipette size to be used Moxidectin [mg/kg Advocate for smal Advocate for large the appropriate combination of pipettes Dogs(Refer to Table 2) Pipette size to be used Moxidectin [mg/kg Advocate for smal Advocate for medium Advocate for large Advocate for extra- the appropriate combination of pipettes Flea treatment and prevention (Cats and Dogs)One treatment prevents future flea infestation for 4 w eeks. Existing pupae in the environment may emerge for 6 w eeks or longerafter treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine Advocate treatmentw ith environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reductionin the household flea population. The product should be administered at monthly intervals w hen used as part of a treatmentstrategy for flea al ergy dermatitis.
Flea treatment and prevention (Ferrets)One treatment prevents future flea infestation for 3 w eeks. Under heavy flea pressure it may be necessary to repeat the doseafter 2 w eeks.
Treatment of ear mite infestation (Otodectes cynotis) (Cats & Dogs)A single dose of the product should be administered. In dogs, loose debris should be gently removed from the external ear canalat each treatment. For both cats and dogs, a further veterinary examination 30 days after treatment is recommended as someanimals may require a second treatment. Do not apply directly to the ear canal.
Treatment of biting lice (Trichodectes canis) (Dogs)A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as someanimals may require a second treatment.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) (Dogs)A single dose should be administered tw ice 4 w eeks apart. Treatment of demodicosis (caused by Demodex canis) (Dogs)The administration of a single dose every 4 w eeks for 2 to 4 months is efficacious against Demodex canis and leads to amarked improvement of clinical signs particularly in mild to moderate cases. Especial y severe cases may require more prolongedand more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian,Advocate can be applied once a w eek and for a prolonged time. In al cases it is essential that the treatment should be continueduntil skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that showno improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek theadvice of your veterinarian.
As demodicosis is a multi-factorial disease, w here possible, it is advisable to also treat any underlying disease appropriately.
Heartworm prevention (Cats, Ferrets & Dogs)Cats, ferrets and dogs in areas endemic for heartw orm, or those w hich have travel ed to endemic areas, may be infected w ithadult heartw orms. Therefore prior to treatment w ith Advocate, the advice provided in Contra-Indications and Warnings etcshould be considered. For prevention of heartw orm disease, the product must be applied at regular monthly intervals during thetime of the year w hen mosquitoes (the intermediate hosts w hich carry and transmit heartw orm larvae) are present. The productmay be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment shouldcontinue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it isrecommended that the same day or date be used each month. When replacing another heartw orm preventative product in aheartw orm prevention programme, the first treatment w ith Advocate must be given w ithin 1 month of the last dose of the formermedication. In non-endemic areas there should be no risk of animals having heartw orm. Therefore they can be treated w ithoutspecial precautions. Roundworm and hookworm treatment (Cats)In areas endemic for heartw orm, monthly treatment may significantly reduce the risk of re-infection caused by the respectiveroundw orms and hookw orms. In areas non-endemic for heartw orm, the product can be used as part of a seasonal preventionprogramme against fleas and gastrointestinal nematodes.
Roundworm, hookworm and whipworm treatment (Dogs) In areas endemic for heartw orm, monthly treatment may significantly reduce the risk of re-infection caused by the respectiveround-, hook- and w hipw orms. In areas non-endemic for heartw orm, the product can be used as part of a seasonal preventionprogramme against fleas and gastrointestinal nematodes. Studies have show n that monthly treatment of dogs w il preventinfections caused by Uncinaria stenocephala.
Treatment and Prevention of Angiostrongylus vasorum (Dogs)A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as someanimals may require a second treatment.
In endemic areas regular four w eekly application w il prevent angiostrongylosis and patent infection w ith Angiostrongylusvasorum.
Treatment of Crenosoma vulpis (Dogs)A single dose should be administered Method of administrationFor external use only.
Remove one pipette from the package. Then hold the pipette in an upright position, and tw ist and pul off the cap. Reverse thecap and use it to tw ist and remove the seal from the pipette, as show n. See Figure 1.
Figure 1: Opening a pipette Cats and FerretsPart the fur on the animal's neck at the base of the skul until the skin is visible. Place the tip of the pipette on the skin andsqueeze the pipette firmly several times to empty its contents directly onto the skin. Application at the base of the skul w ilminimise the opportunity for the animal to lick the product. Apply only to undamaged skin. See figure 2.
Figure 2: Administration to the Cat or Ferret For dogs up to 25kgWith the dog in a standing position, part the coat betw een the shoulder blades until the skin is visible. Wherever possible apply toundamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directlyonto the skin. See Figure 3.
Figure 3: Administration to dogs up to 25kg For dogs of more than 25 kg For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spotsalong the top of the back, from betw een the shoulders to the base of the tail. At each spot, part the coat until the skin is visible.
Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel aportion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could causesome of the product to run dow n the animal's side. See Figure 4.
Figure 4: Administration to dogs over 25kg Use During Pregnancy and LactationThe safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies w itheither imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxiceffects. Use only according to the risk-benefit assessment by the responsible veterinarian.
Contra-indications, warnings, etcDo not use in kittens under 9 w eeks of age.
Do not use in puppies under 7 w eeks of age.
Treatment of cats or dogs w eighing less than 1 kg, and ferrets w eighing less than 0.8 kg should be based on a risk-benefitassessment.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used basedon a risk-benefit assessment for these animals.
For cats, the corresponding "Advocate spot-on solution for cat" product, w hich contains 100 mg/ml imidacloprid and 10 mg/mlmoxidectin, must be used.
For ferrets: Do not use Advocate for large cats (0.8ml) or Advocate for dogs (any size), only "Advocate for smal cats andferrets" (0.4 ml) must be used. The product's efficacy has not been tested in ferrets w eighing over 2 kg and therefore theduration of effect might be shorter in these animals.
For dogs, the corresponding "Advocate for dog" product, w hich contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, mustbe used.
The product tastes bitter. Salivation may occasional y occur if the animal licks the application site immediately after treatment.
This is not a sign of intoxication and disappears w ithin some minutes w ithout treatment. Correct application w il minimize licking ofthe application site.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no know n specific antidote. The use ofactivated charcoal may be beneficial. After accidental oral ingestion (i.e. licking at the site of application) or overdose,neurological signs (most of w hich are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupil aryreflex, nystagmus), abnormal respiration, salivation and vomiting may be observed in very rare cases.
The use of the product may result in transient pruritus in the animal. On rare occasions greasy fur, erythema and vomiting canoccur. These signs disappear w ithout further treatment. The product may, in rare cases cause local hypersensitivity reactions.
The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such aslethargy, agitation, and inappetence.
Care should be taken that the content of the pipette or the applied dose does not come into contact w ith the eyes or mouth of therecipient and/or other animals.
Do not al ow recently treated animals to groom each other.
When the product is applied in 3 to 4 separate spots in larger dogs, specific care should be taken to prevent the animal lickingthe application sites. Oral uptake by Col ies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.
During treatment w ith Advocate no other antiparasitic macrocyclic lactone should be administered. This product containsmoxidectin (a macrocyclic lactone), therefore special care should be taken w ith Col ies, Old English Sheepdogs and relatedbreeds or crossbreeds, to correctly administer the product as described above. In particular, oral uptake by the recipient and/orother animals in close contact should be prevented.
Ivermectin-sensitive Col ie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals w ithout anyadverse effects, but the safety of application at w eekly intervals has not been investigated in ivermectin-sensitive Col ie dogs.
When 40% of the unit dose w as given oral y, severe neurological signs w ere observed. Oral administration of 10% of therecommended dose produced no adverse effects.
Up to 10 times the recommended dose w as tolerated in adult dogs w ith no evidence of adverse effects or undesirable clinicalsigns. Five times the recommended minimum dose applied at w eekly intervals for 17 w eeks w as investigated in dogs aged over6 months and tolerated w ith no evidence of adverse effects or undesirable clinical signs.
Up to 10 times the recommended dose w as tolerated in cats w ith no evidence of adverse effects or undesirable clinical signs.
The product w as administered to kittens and puppies at up to 5 times the recommended dose, every 2 w eeks for 6 treatments, and there w ere no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration w ereobserved.
The product w as administered to ferrets at 5 times the recommended dose, every 2 w eeks for 4 treatments, and there w as noevidence of adverse effects or undesirable clinical signs.
It is recommended that cats and ferrets living in, or travel ing to areas endemic for heartw orm are treated monthly w ith theproduct to protect them from heartw orm disease. Whilst the accuracy of diagnosis of heartw orm infection is limited, it isrecommended that attempts be made to check the heartw orm status of any cat and ferret aged over 6 months, before beginningprophylactic treatment, as use of the product on cats or ferrets w hich have adult heartw orms may cause serious adverseeffects, including death. If adult heartw orm infection is diagnosed, the infection should be treated in accordance w ith currentscientific know ledge.
Although the product may be safely administered to dogs infected w ith adult heartw orms, it has no therapeutic effect againstadult Dirofilaria immitis. It is therefore recommended that al dogs 6 months of age or more, living in areas endemic forheartw orm, should be tested for existing adult heartw orm infection before being treated w ith the product.
Dogs infected w ith adult heartw orms tolerated up to 5 times the recommended dose, every 2 w eeks for 3 treatments, w ithoutany adverse effects.
No interactions betw een Advocate and routinely used veterinary medicinal products or medical or surgical procedures havebeen observed.
Brief contact of the animal w ith w ater on one or tw o occasions betw een monthly treatments is unlikely to significantly reducethe efficacy of the product. How ever, frequent shampooing or immersion of the animal in w ater after treatment may reduce theefficacy of the product.
Parasite resistance to any particular class of anthelmintic may develop fol ow ing frequent, repeated use of an anthelmintic ofthat class.
The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Al owthe application site to dry before permitting contact w ith such materials.
User SafetyAvoid contact w ith skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
In case of accidental spil age onto skin, w ash off immediately w ith soap and w ater.
After application do not stroke or groom animals until the application site is dry.
People w ith a know n hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product w ith caution. Invery rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation orburning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals.
If the product accidental y gets into eyes, they should be thoroughly flushed w ith w ater.
If skin or eye symptoms persist, or the product is accidental y sw al ow ed, seek medical attention and show the package insert tothe physician.
Environmental SafetyAdvocate should not be al ow ed to enter surface w aters as it has harmful effects on aquatic organisms: moxidectin is highlytoxic to aquatic organisms. Dogs should not be al ow ed to sw im in surface w aters for 4 days after treatment.
Any unused product or w aste materials derived from such veterinary medicinal products should be disposed of in accordancew ith local requirements.
Pharmaceutical precautionsDo not store above 30°C.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 yearsLegal categoryPOM-VPackaging QuantitiesWhite polypropylene unit dose pipette w ith screw cap.
Product name Advocate Spot-on solution for Smal Cats and Ferrets Blister pack containing 3 or 6 unit dose pipettes: 0.4 ml per pipette Advocate Spot-on solution for Large Cats Blister pack containing 3 or 6 unit dose pipettes: 0.8 ml per pipette Advocate Spot-on solution for Smal Dogs Blister pack containing 3 unit dose pipettes: 0.4 ml per pipette Advocate Spot-on solution for Medium Dogs Blister pack containing 3 or 6 unit dose pipettes: 1.0 ml per pipette Advocate Spot-on solution for Large Dogs Blister pack containing 3 or 6 unit dose pipettes: 2.5 ml per pipette Advocate Spot-on solution for Extra-Large Dogs Blister pack containing 3 or 6 unit dose pipettes: 4.0ml per pipette Further informationPharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code: QP54AB52.
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to thechloronicotinyl group of compounds. Chemical y, it is more accurately described as a chloronicotinyl nitroguanidine. Imidaclopridis effective against larval flea stages and adult fleas. Flea larvae in the pet's surroundings are kil ed after contact w ith a pet treated w ith the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region ofthe central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysisand death. Due to the w eak nature of the interaction w ith mammalian nicotinergic receptors and the postulated poor penetrationthrough the blood-brain barrier in mammals, it has virtual y no effect on the mammalian CNS. Imidacloprid has minimalpharmacological activity in mammals. Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is aparasiticide w hich is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) ofDirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts w ith GABA and glutamate-gatedchloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions andinduction of an irreversible resting state. The result is flaccid paralysis of affected parasites, fol ow ed by their death and/orexpulsion.
After topical administration of the product, imidacloprid is rapidly distributed over the animal's skin w ithin one day of application. Itcan be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximumplasma concentrations approximately 1 to 2 days after treatment in cats and approximately 4 to 9 days after treatment in dogs.
Fol ow ing absorption from the skin, moxidectin is distributed systemical y and is slow ly eliminated from the plasma as manifestedby detectable moxidectin concentrations in plasma throughout the treatment interval of one month.
Marketing Authorisation Holder (if different from distributor) M arketing Authorisation HolderBayer Animal Health GmbH, D-51368 Leverkusen, Germany Distributed byUK: Bayer plc, Animal Health Division, Bayer House, Straw berry Hil , New bury, Berkshire, RG14 1JAIreland: Bayer Ltd, Animal Health Division, The Atrium, Blackthorn Road, Sandyford Ind Est, Dublin 18Marketing authorisation number EU/2/03/039/001 - 012 Significant ChangesPrevention of Angiostrongylus vasorumTreatment of Crenosoma vulpisAmended treatment protocol for severe cases of demodicosis New indications - Angiostrongylus 13/08/2007vasorum and Trichodectes canis Additional species - Ferret : For the treatment and prevention offlea infestation (Ctenocephalidesfelis) and the prevention ofheartw orm disease (L3 and L4larvae of Dirofilaria immitis).
GTIN (Global Trade Item No)Advocate Spot-on solution for Smal Cats and Ferrets (3 Pack)04007221016878Advocate Spot-on solution for Smal Cats and Ferrets (6 Pack)04007221020691Advocate Spot-on solution for Large Cats (3 Pack)04007221016885Advocate Spot-on solution for Large Cats (6 Pack)04007221020684Advocate Spot-on solution for Smal Dogs (3 Pack)04007221016892Advocate Spot-on solution for Medium Dogs (3 Pack)04007221016908Advocate Spot-on solution for Medium Dogs (6 Pack)04007221020677Advocate Spot-on solution for Large Dogs (3 Pack)04007221016915Advocate Spot-on solution for Large Dogs (6 Pack)04007221020660Advocate Spot-on solution for Extra-large Dogs (3 Pack)04007221016922Advocate Spot-on solution for Extra-large Dogs (6 Pack)04007221020653

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