NAME PANACUR 187.5 MG/G PASTE FOR ORAL ADMINISTRATION FOR DOGS AND CATS ACTIVE INGREDIENTS Each g of paste contains the active substance: fenbendazole 187.5 mg. EXCIPIENTS Methyl parahydroxybenzoate 1.7 mg, propyl parahydroxybenzoate 0.16 mg, carbomer 980, propylene glycol, glycerol (85%), liquid sorbitol (crystallizable), sodium hydroxide, demineralized water. THERAPEUTIC INDICATIONS Treatment of gastrointestinal nematode infections in kittens and adult cats and in puppies and adult dogs. In dogs, also as an adjunct in the control of the protozoan Giardia. Cats and adult cats. Infestation with the following gastrointestinal nematodes: Toxocara cati (adult stages); Ancylostoma tubaeforme (immature and adult stages). Puppies and adult dogs. Infestation with the following gastrointestinal parasites: Toxocara canis (adult stages); Ancylostoma caninum (adult stages); Uncinaria stenocephala (immature and adult stages) and Giardia spp. CONTRAINDICATIONS / ADVERSE EFFECTS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES Benzimidazoles have a wide margin of safety. No specific symptoms of overdose are known. No specific action is required. DOSAGE Oral administration. The veterinary medicinal product should be administered directly into the mouth after feeding by squeezing the paste from the syringe onto the base of the tongue. Alternatively, the paste may also be mixed with food. Each syringe contains 4.8 g of paste, equivalent to 900 mg fenbendazole. To prepare the syringe for first use, remove the tip of the syringe and turn the dosing ring until the edge of the ring facing the tip aligns with the zero (0) on the plunger. Depress the plunger and discard the spilled paste. The syringe is ready for use. The plunger has 18 markings, each unit corresponding to 50 mg fenbendazole. Determine the number of units required according to the body weight of the animal. Turn the plunger ring to the appropriate marking. Depress the plunger without applying excessive force. A maximum of 6 doses of the product can be withdrawn within 28 days of first opening the primary packaging. To ensure the administration of a correct dose, the body weight should be determined as accurately as possible. The veterinary medicinal product is suitable for use in animals weighing up to 6 kg, regardless of their age. If the animal weighs more than 6 kg, more syringes are required. Adult cats: The dose is 75 mg fenbendazole/kg body weight (BW)/day, for two consecutive days. The daily dose for 2 kg BW corresponds to 3 markings on the plunger. The resulting treatment regimen is as follows: up to 2 kg BW: 3 syringe marks per day, for 2 days; 2.1 to 4 kg GC: 6 syringe marks per day for 2 days; 4.1 to 6 kg body weight: 9 syringe marks per day for 2 days, etc. Kittens, puppies and adult dogs: The dose is 50 mg fenbendazole/kg body weight/day for three consecutive days. The treatment regimen is as follows: 1.0 to 2 kg body weight 2 syringe marks per day for 3 days 2.1 to 3 kg body weight 3 syringe marks per day for 3 days 3.1 to 4 kg body weight 4 syringe marks per day for 3 days 4.1 to 5 kg body weight 5 syringe marks per day for 3 days 5.1 to 6 kg body weight 6 syringe marks per day for 3 days, etc. In particular, in conditions of severe infestation, the elimination of Ancylostoma tubaeforme in adult cats, Giardia spp. in dogs and roundworms, especially in puppies and kittens, may be incomplete in individual cases and therefore a potential risk of infestation for humans remains. A faecal examination should therefore be performed and, based on the results, additional treatment should be administered if necessary, at the discretion of the veterinarian. STORAGE: Do not store above 25°C. Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 28 days. WARNINGS: For both animal species, in order to achieve effective control of gastrointestinal nematodes and giardiasis in dogs, treatment should be based on the results of the faecal parasitological examination. Unnecessary use of antiparasitics or use deviating from the instructions provided in this summary of product characteristics may increase the selection pressure for resistance and reduce their efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasite species and parasite load or the risk of infestation based on epidemiological characteristics, for each individual animal. Precautions should be taken to avoid the following practices, which may increase the risk of resistance development and could ultimately lead to treatment failure: excessively frequent and repeated use of anthelmintics of the same class over an extended period of time; underdosing, which may be caused by underestimation of the animal’s body weight, incorrect administration of the veterinary medicinal product or loss of calibration of the dosing device. It is also advisable to verify the success of the treatment (e.g. by checking the clinical appearance and the number of eggs in the faeces). Clinical cases of suspected anthelmintic resistance should be further investigated using appropriate methods (e.g. faecal egg count reduction test (FECRT). If the results of the method clearly indicate resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mechanism of action should be used. Special precautions for safe use in the target species: The possibility that other animals living in the same household may be a source of reinfestation with gastrointestinal nematodes should be considered and these should be treated, as necessary, with an appropriate veterinary medicinal product. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Avoid contact with skin, eyes and mucous membranes. In case of contact with skin and/or eyes, rinse immediately with plenty of water. Wash hands after use. Do not eat, drink or smoke during administration. Special precautions for environmental protection: Not applicable. Benzimidazoles have a wide margin of safety. No specific symptoms of overdose are known. No specific action is required. Incompatibilities: None known. TARGET SPECIES: Dog, cat. INTERACTIONS: None known. DIAGNOSIS AND PRESCRIPTION: Veterinary medicinal product not subject to medical prescription. ADVERSE REACTIONS: Dogs, cats. Very rare (< 1 animal/10,000 animals treated, including isolated reports): gastrointestinal disorders (e.g. vomiting and diarrhoea). Diarrhoea is usually mild. Reporting of adverse events is important as it allows the continuous monitoring of the safety of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to the marketing authorisation holder or his local representative or to the national competent authority via the national reporting system. See also the package leaflet for contact details. PREGNANCY AND LACTATION: Pregnancy and lactation: Do not use in pregnant bitches until at 18 months of age. 39th day of gestation. The veterinary medicinal product can be used for the treatment of pregnant bitches in the last third of pregnancy. However, as rare cases of teratogenic effects caused by oxfendazole, a metabolite of fenbendazole, cannot be completely excluded, it should only be used according to the benefit-risk assessment by the responsible veterinarian. Do not use in pregnant cats. The veterinary medicinal product can be used in lactating dogs and cats