Excipient: Butylated hydroxytoluene.

INDICATIONS:

For cats infested with or at risk of concurrent infestation with cestodes, nematodes and ectoparasites. The veterinary medicinal product is specifically indicated when all three groups are targeted simultaneously. Ectoparasites - Treatment and prevention of flea infestations (Ctenocephalides felis). Eliminates fleas within 24 hours of application. One treatment provides protection against new infestation for at least one month. - Prevention of environmental contamination with fleas by inhibiting the development of fleas at all stages of development (eggs, larvae and pupae) for over one month. - The product can be part of a treatment strategy for the control of flea allergy dermatitis (FAD). - Treatment and prevention of tick infestations (Ixodes ricinus). Eliminates ticks within 48 hours of application. One treatment provides protection against new infestation for up to 3 weeks.

Cestodes - Treatment of tapeworm infestations (cestodes) (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis). // Nematodes - Treatment of gastrointestinal nematode infestations (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and adult forms of Toxocara leonina and Ancyclostoma braziliense). - Treatment of bladder worm infestations (Capillaria plica). - Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.

CONTRAINDICATIONS

Do not use on sick animals (e.g., systemic diseases, fever) or during convalescence. Do not use on rabbits. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

After treatment, the coat may temporarily appear sticky at the application site. This is normal and self-resolving. Mild and transient skin reactions may occur at the application site (local alopecia, pruritus) which will disappear without treatment. If the cat licks its coat after treatment, temporary excessive salivation may be observed. Ingestion of the product can lead to vomiting and/or transient neurological symptoms such as ataxia, disorientation, apathy and pupil dilation. All these symptoms resolve spontaneously within 24 hours. Correct application will minimize the occurrence of these reactions. If you notice serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

TARGET SPECIES: Cats

ROUTE AND METHOD OF ADMINISTRATION:

Spot-on administration. The recommended minimum doses are 10 mg/kg body weight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel. The product should only be used if mixed infestation is confirmed or if there is a risk of mixed infestation with ectoparasites and nematodes (including for heartworm prevention) and when concomitant cestode treatment is indicated. In the absence of a risk of concurrent contamination, a narrow-spectrum parasiticide is recommended as a first treatment option. The indication for use should be adapted according to the cat's needs determined by clinical evaluation, the animal's lifestyle and the local epidemiological situation (including zoonotic risks where applicable) so that it is used exclusively in situations of mixed infestation or risk of mixed infestation. Treatment should not be extrapolated from one animal to another without veterinary approval. For the prevention of cardiovascular dirofilariasis (Dirofilaria immitis larvae), the product should be applied starting 1 month before the first exposure to mosquitoes.

RECOMMENDATIONS FOR CORRECT ADMINISTRATION Choose the appropriate applicator according to the cat's weight. Use scissors to cut the blister along the dotted line, then peel off the foil. Remove the applicator from the package and hold it upright. Pull the plunger back slowly, twist and remove the cap. Part the fur in the middle of the neck, between the base of the skull and the shoulder blades, so that the skin is visible. Position the tip of the applicator on the skin and apply the entire contents directly onto the skin in one spot. The product must be applied to dry skin in areas where the cat cannot lick itself. For long-haired breeds, particular care must be taken to apply the product directly to the skin and not to the fur to ensure optimal efficacy.

STORAGE Keep out of the sight and reach of children. Store in the original cardboard packaging to protect from light. Do not use this veterinary product after the expiry date marked on the box after EXP.

Special precautions for each target species: Ensure that animals do not lick each other after treatment. After treatment, ticks are generally killed within 48 hours of infestation without engaging in blood-feeding activity. However, some ticks may remain on the animal and for this reason, the transmission of infectious diseases cannot be completely ruled out. No data are available regarding the effect of bathing/shampooing on the product's efficacy in cats. Brief water contact once a month after product application is unlikely to significantly reduce the product's efficacy. However, as a precaution, bathing the animal for 2 days after treatment is not recommended. Tapeworm infestation may recur if intermediate hosts such as fleas, mice, etc. are not controlled. Parasite resistance to a particular class of antiparasitic drugs can develop as a result of frequent use of a compound from that class. Therefore, available information regarding the current susceptibility of the target species should be taken into account to limit the possibility of future selection of resistance. Cats living in heartworm endemic areas or those that have traveled to such areas may be infested with adult heartworms. Although the product can be administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis heartworms has been established. Therefore, it is recommended that all cats aged 6 months or older living in heartworm endemic areas be tested for adult heartworm infestation before prophylactic product application.

Special precautions for use in animals: For spot-on application only. Do not inject, administer orally or by any other route of administration. Avoid contact with the cat's eyes. The safety of BROADLINE has not been tested for intervals shorter than 2 weeks or in kittens weighing less than 0.6 kg and/or aged 7 weeks.

BROADLINE is not intended for use in dogs. Certain dog breeds may have increased susceptibility to macrocyclic lactones, which can cause neurotoxic effects. Ingestion by breeds such as Collies, English Sheepdogs, and mixed or related breeds should therefore be avoided. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Do not smoke, drink or eat while handling the product. Wash hands thoroughly after use. Avoid contact of fingers with the applicator contents. If this happens, wash with soap and water. In case of accidental eye contact, rinse thoroughly with water as the product may cause mild eye irritation. If eye irritation persists or adverse effects occur, seek medical advice and show the doctor the product leaflet or label. Avoid handling the animal until the application site is dry, and children should not play with the animals during this period. Therefore, it is recommended that recently treated animals do not sleep with their owners, especially children. Persons with known hypersensitivity to any of the active substances or excipients should not handle this veterinary medicinal product. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies for each active substance performed on rats and rabbits have not shown teratogenic, feto-toxic, materno-toxic effects. Use only in accordance with the veterinarian's risk/benefit assessment. Overdose: Safety has been demonstrated in healthy kittens aged 7 weeks or older who received a dose up to 5 times the maximum allowed dose (e.g., up to 15 times the recommended dose), treated up to 6 times, at four-week intervals. Safety has also been demonstrated in healthy adult cats treated 3 times at 2-week intervals with a dose up to 5 times the recommended dose. Transient neurological signs such as ataxia, disorientation, apathy and dilated pupils may be observed, which usually resolve spontaneously the next day – see their description in section 6. Cats infected with adult heartworms tolerated up to 3 times the maximum allowed dose (e.g., up to 9 times the recommended dose), 3 treatments at 4-week intervals, without any adverse effects.

DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE Medicines must not be disposed of in lakes, watercourses or ditches due to the danger to fish and other aquatic organisms. Ask your veterinarian for information on how to dispose of medicines that are no longer needed.