Profender Spot-on Solution for cats Species: Cats Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats, Tapeworm products Active ingredient: Emodepside, Praziquantel Product:Profender® Spot-on Solution for small cats Profender® Spot-on Solution for medium cats Profender® Spot-on Solution for large cats Product index: Profender Spot-on Solution Incorporating:Profender 30 mg/7.5 mg spot-on solution for small cats Profender 60 mg/15 mg spot-on solution for medium cats Profender 96 mg/24 mg spot-on solution for large cats Presentation Profender spot-on solution for cats is a clear yellow to brown solution containing 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel, with 5.4 mg/ml butylhydroxyanisole (E320) as antioxidant. The product is presented in a single use plastic pipette for dermal (spot-on) application. Profender spot-on solution for small cats is a 0.35 ml pipette containing 7.5 mg emodepside and 30 mg praziquantel. Profender spot-on solution for medium cats is a 0.70 ml pipette containing 15 mg emodepside and 60 mg praziquantel. Profender spot-on solution for large cats is a 1.12 ml pipette containing 24 mg emodepside and 96 mg praziquantel. Uses For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms, tapeworms and lungworms of the following species: Roundworms (Nematodes) •Toxocara cati (mature adult, immature adult, L4 and L3) •Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring •Toxascaris leonina (mature adult, immature adult and L4) •Ancylostoma tubaeforme (mature adult, immature adult and L4) Tapeworms (Cestodes) •Dipylidium caninum (mature adult and immature adult) •Taenia taeniaeformis (adult) •Echinococcus multilocularis (adult) Lungworms •Aelurostrongylus abstrusus (adult) Dosage and administration Dosage and Treatment Schedule See Table 1. The recommended minimum doses are 3 mg emodepside/kg body weight and 12 mg praziquantel/kg body weight, equivalent to 0.14 ml Profender/kg body weight. Table 1: Body weight of cat (kg) Pipette size to be used Volume (ml) Emodepside (mg/kg bw) Praziquantel (mg/kg bw) ≥0.5 - 2.5 Profender for Small Cats 0.35 3 - 15 12 - 60 >2.5 - 5 Profender for Medium Cats 0.70 3 - 6 12 - 24 >5 - 8 Profender for Large Cats 1.12 3 - 4.8 12 - 19.2 >8 Use an appropriate combination of pipettes For the treatment of roundworms and tapeworms a single administration per treatment is effective. For the treatment of queens to prevent lactogenic transmission of Toxocara cati (L3 larvae) to the offspring, a single administration per treatment approximately seven days prior to expected parturition is effective. For the lungworm Aelurostrongylus abstrusus, two treatments administered two weeks apart are effective. Method of administration For external use only. Remove one pipette from package. Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal. See Figure 1. Description: h-305 Figure 1: Opening a pipette Part the fur on the cat’s neck at the base of the skull 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. Application on the base of the skull will minimise the ability of the cat to lick the product off. See Figure 2. Description: h-306Description: h-307 Figure 2: Administration Use During Pregnancy and Lactation Profender can be used during pregnancy and lactation. Contra-indications, warnings, etc Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Apply only to the skin surface and on intact skin. Do not administer orally or parenterally. Avoid the treated cat or other cats in the household licking the site of application while it is wet. Salivation and vomiting may occur in very rare cases. Mild and transient neurological disorders such as ataxia or tremor may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site immediately after treatment. In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site. 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). Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible. There is no known specific antidote. Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential clinical consequences of such interactions have not been investigated. Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals therefore should not be bathed until the solution has dried. There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials. User Safety Read the package leaflet before use. Do not smoke, eat or drink during application. Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time. Wash hands after use. In case of accidental spillage onto skin, wash off immediately with soap and water. If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water. If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product. Environmental Safety Profender should not be allowed to enter water courses as emodepside has shown harmful effects on aquatic organisms. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Pharmaceutical precautions Store in the original package in order to protect from moisture. Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Legal category Legal category: POM-V