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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/621439/2013

EMEA/V/002700

EPAR summary for the public

Broadline

Fipronil/(S)-methoprene/eprinomectin/praziquantel

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal's medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Broadline?

Broadline is a veterinary medicine that contains four active substances: fipronil, (S)-methoprene, eprinomectin and praziquantel. It is available as a spot-on solution in applicators of two different strengths for use in cats of various bodyweights.

The content of one full applicator (appropriate to the cat's weight) is applied directly to the cat's skin after parting the hair, in one spot on the middle of the neck.

What is Broadline used for?

Broadline is used to treat cats with, or at risk of, mixed infestations by tapeworms, roundworms and external parasites (fleas, ticks and a burrowing mite called Notoedres cati). The product is to be used only when all three groups of parasites are targeted at the same time.

For external parasites, Broadline treats flea infestations and prevents new infestations for at least one month; it also prevents environmental flea contamination for over a month. It may also be used as part of a treatment strategy for flea allergy dermatitis (an allergic reaction to flea bites). It treats tick infestations and prevents new infestations for up to three weeks.

For worms, Broadline is used to treat tapeworms and roundworms in the gut as well as a type of worm that infests the bladder and a type of feline lungworm. For lungworm a second treatment may be

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recommended one month after the initial treatment. Broadline can also be used to prevent heartworm disease for one month.

How does Broadline work?

Two of the active substances in Broadline, fipronil and (S)-methoprene, act as 'ectoparasiticides'. This means that they kill external parasites that live on the skin or in the fur of animals, such as fleas and ticks. Two of the active substances in Broadline, eprinomectin and praziquantel, act as 'endoparasiticides'. This means that they kill parasites that live inside the body of animals.

Fipronil kills adult parasites. It blocks channels in their nerve cells that allow charged chloride particles (ions) to pass, interfering with the transmission of nerve signals and leading to overstimulation and death.

(S)-Methoprene is an insect growth regulator which stops the flea life cycle by killing eggs and blocking the development of juvenile flea stages and causing their death.

Eprinomectin interferes with channels in the nerve and muscle cells of roundworms that allow charged chloride particles (ions) to pass, leading to their paralysis and death.

Praziquantel acts on the cell membranes of tapeworms leading to the death of the parasite.

How has Broadline been studied?

A number of laboratory studies were conducted in cats to determine the effective dose against the relevant parasites. The effectiveness of Broadline against Notoedres cati was examined in a laboratory study with 18 naturally infested cats. The measure of effectiveness was reduction of the number of mites found in skin scrapings compared to cats that received no treatment.

The effectiveness of Broadline against fleas and ticks was investigated in three field studies. The main EU study involved male and female cats of various ages infested with fleas, ticks, or both. The Broadline-treated cats were compared with cats treated with a spot-on medicine containing fipronil and (S)-methoprene. The effectiveness was measured by the number of fleas and ticks up to day 30 after treatment.

A field study in Japan involved cats with flea infestations which were either treated with Broadline or a spot-on medicine containing the active substance selamectin. Effectiveness was measured by the number of fleas at day 2 and day 30 after treatment.

A second field study in Japan involved cats with tick infestations which were either treated with Broadline or a spot-on containing fipronil and (S)-methoprene. Effectiveness was measured by the number of ticks at day 30 after treatment.

The effectiveness of Broadline against worms was investigated in one EU field study involving cats of various ages and both genders with tapeworm or roundworm infections or both. Broadline treated cats were compared to cats treated with a spot-on product containing the worm medicines emodepside and praziquantel. Effectiveness was measured by identifying adult worm segments (tapeworms) or counting worm eggs (roundworms) in faeces at day 14 after treatment.

The effectiveness of Broadline against feline lungworm was investigated in a field study in Italy.

Twenty cats naturally infested with lungworm were treated with Broadline. The main measure of effectiveness was reduction of numbers of worm larvae in faeces at 28 days after single treatment.

What benefit has Broadline shown during the studies?

The main EU study showed effectiveness of 86 to 87% against adult fleas for Broadline throughout the 30 day post-treatment period compared with between 76 and 82% for the cats treated with just fipronil and (S)-methoprene. For ticks effectiveness was between 85 and 93% for Broadline-treated cats compared with 92 and 98% for cats treated with the comparator product.

The first Japanese study showed Broadline to be 99% effective against fleas at day 2 and 30 posttreatment which was the same as the spot-on containing selamectin.

The second Japanese study showed Broadline to be 94% effective against ticks at day 30 posttreatment, compared with 91% for the fipronil and (S)-methoprene-treated cats.

A laboratory study in cats with mange due to Notoedres cati infection showed over 98% effectiveness of the medicine against the mite with a clinical cure in all animals.

The EU worm study showed almost 100% effectiveness against tapeworms and roundworms for both Broadline and the comparator product.

Broadline was more than 90% effective in reducing lungworm larvae at 28 days after treatment and all treated cats showing respiratory signs (such as wheezing, persistent coughing and a runny nose) were clinically cured.

What is the risk associated with Broadline?

Mild and short-lived skin reactions (itching, hair loss) may occur at the application site. If the cat licks the application site, temporary excessive salivation may occur. If a cat swallows the medicine it may result in vomiting (being sick) and/or short-lived effects on the nervous system, shown by signs such as lack of muscular coordination, disorientation, lack of interest in surroundings and pupil dilation. All these signs resolve spontaneously within 24 hours.

Broadline must not be used in sick or recovering animals. It must not be used in rabbits or in cases of hypersensitivity (allergy) to any of the ingredients.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

People applying the medicine should not smoke, eat or drink while doing so and should wash their hands after handling the product.

Contact with the applicator should be avoided. If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin, the skin should be washed with soap and water. If eye irritation persists, or if side effects are noticed, medical advice should be sought and the package leaflet or label shown to the doctor.

People with known hypersensitivity to any of the ingredients should avoid contact with the product. Handling of treated animals should be limited until the application site is dry and children should not play with treated animals during this period. Consequently, it is recommended that recently treated animals do not sleep with owners, especially children.

Why has Broadline been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Broadline exceed the risks for the approved indications and recommended that Broadline be given a

Broadline marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Broadline:

The European Commission granted a marketing authorisation valid throughout the European Union, for Broadline on 04/12/2013. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in March 2015.

Broadline

EMA/621439/2013

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