Broadline Spot-on for Large Cats 2.5-7.5kg (6 pipettes)

Active substances

Fipronil 74.7 mg

[S]-methoprene 90 mg

Eprinomectin 3.6 mg

Praziquantel 74.7 mg

Broadline is a prescription product and must be applied according to the instructions by your veterinary surgeon.

Please read the product leaflet thoroughly before applying to your pet.

Marketing Authorisation Holder

MERIAL

29, Avenue Tony Garnier

69007 Lyon

FRANCE

Marketing Authorisation Number

EU/2/13/157/001-011

Contra-indications

• Do not use in sick or convalescent animals.
• Do not use in rabbits.
• Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Special warnings for each target species

• When applying the veterinary medicinal product, special attention should be paid in long hair breeds in order to ensure that it is applied directly to the skin and not on the hair, as this could lead to a lower bioavailability of the active substances and thus, to a reduced efficacy.
• It is important to apply the veterinary medicinal product to a skin area where the cat cannot lick it off. Avoid animals licking each other following treatment.
• No data on the effect of bathing/shampooing on the efficacy of the product in cats is available. However, brief contact of the animal with water on one or two occasions within the month following application is unlikely to significantly reduce its efficacy. As a precaution, it is not recommended to bathe animals within 2 days after treatment.
• After treatment with BROADLINE, ticks will generally be killed within 48 hours after infestation without having a blood meal. However, since the attachment of single ticks after treatment cannot be excluded, transmission of infectious diseases cannot be completely ruled out.
• Tapeworm infestation may reoccur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
• In certain individual cats Notoedres cati infestation may be severe or complicated by bacterial infections. In these severe cases concomitant treatment may be necessary.
• Parasite resistance to any particular class of antiparasitic drug may develop following frequent use of a compound of that class. Therefore, epidemiological information about current susceptibility of the target species should be taken into account in order to limit the possibility of a future selection for resistance.
• Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Although the veterinary medicinal product may be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis has been established. It is therefore recommended that all cats 6 months of age or more, living in areas endemic for heartworm should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.

Special precautions for use in animals

• Spot-on application only. Do not inject, do not administer orally or via any other route. Avoid contact with the cat's eyes. The safety of the veterinary medicinal product has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
• The veterinary medicinal product is not intended for use in dogs. Some dog breeds may present increased susceptibility to macrocyclic lactones, potentially leading to signs of neurotoxicity. Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should thus be avoided.
• Echinococcosis represents a hazard for humans, and is a notifiable disease to the World Organisation for Animal Health (OIE).

Special precautions to be taken by the person administering the veterinary medicinal product to animals

• Do not smoke, drink or eat during application. Wash hands after use. Unused applicators must be stored in the intact blister package.
• Avoid contact of the applicator content with the fingers. If this occurs, wash off with soap and water. In case of accidental eye exposure flush the eyes thoroughly with water, as the product can cause slight mucous membrane and eye irritation. If eye irritation persists or if side effects are noted, seek medical advice and show the package leaflet or the label to the physician.
• Handling of treated animals should be limited until the application site is dry, and children should not be allowed to play with treated animals during this period. It is therefore recommended that recently treated animals do not sleep with owners, especially children.
• People with a known hypersensitivity to any of the active ingredients or excipients should avoid contact with the veterinary medicinal product.

Adverse reactions

• A temporary clumping or spiking of the hair may be seen at the application site after treatment.
• Mild and transient skin reactions at the application site (itching, hair loss) may occur.
• If the cat licks the application site after treatment, temporary excessive salivation can be observed. Oral ingestion of the veterinary medicinal product may also result in vomiting and/or in transient neurological signs such as ataxia, disorientation, apathy and pupil dilation.
• All these signs resolve spontaneously within 24 hours. Correct application will minimise the occurrence of such events.

Use during pregnancy, lactation or lay

• The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with the individual ingredients in rats and rabbits have not produced teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit-risk assessment by the prescribing veterinarian.

Interactions

• None known.