1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing Authorisation Holder:
Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Netherlands

Manufacturer responsible for series release:

Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

40 – 56 kg)

1. STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Each ml contains 280 fluralaner.

Each pipette provides:

Clear, colorless to yellow solution

1. INDICATION(S)

For the treatment of tick and flea infestations in dogs.

This veterinary medicinal product is a systemic insecticide and acaricide which provides:

- immediate and persistent killing activity for fleas (Ctenocephalides felis and Ctenocephalides canis) for 12 weeks, and

- immediate and persistent killing activity for ticks (Ixodes ricinus, Rhipicephalus sanguineus

and Dermacentor reticulatus) for 12 weeks for

Fleas and ticks must be attached to the host and feeding in order to be exposed to the active substance.

The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

1. CONTRAINDICATIONS

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

1. ADVERSE REACTIONS

Common adverse reactions observed in clinical trials (1.2% of treated dogs) were mild reactions and

transient skin reactions such as erythema or alopecia at the application site.

The frequency of adverse reactions is defined using the following convention:

- Very common (more than 1 in 10 animals showing adverse reactions during a treatment)

- Common (more than 1 but less than 10 animals in 100 animals)

- Uncommon (more than 1 but less than 10 animals in 1,000 animals)

- Rare (more than 1 but less than 10 animals in 10,000 animals)

- Very rare (less than 1 animal in 10,000 animals, including isolated reports)

If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.

1. TARGET SPECIES

Dogs

1. DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND

METHOD OF ADMINISTRATION

For spot-on use.

Bravecto should be administered according to the following table (corresponding to a dose of 25-56

fluralaner/kg body weight):

For dogs over 56 kg body weight, use a two-pipette combination that best fits your dog.

better with the weight of the animal.

1. RECOMMENDATIONS ON CORRECT ADMINISTRATION

Method of administration:

Step 1: Immediately before use, open the sachet and remove the pipette. The pipette should be held by the base or the rigid upper portion under the cap in a vertical position (tip up) to open.

The cap must be turned clockwise or

counterclockwise one full turn. The cap will remain on the pipette; it cannot be removed. The pipette is open and ready for use when the seal is felt to break.

Step 2: The dog should be standing or lying down with its back horizontal during application. Place

the tip of the pipette on the skin vertically, between the dog's shoulder blades.

Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog's skin in one (when the volume is small) or more spots, along the dog's dorsal line from the shoulder blade to the base of the tail. Avoid applying an excessive amount of solution to a single spot as it may run or drip off the dog.

Treatment regimen:

For optimal control of tick and flea infestation, the product should be administered at 12-week intervals.

1. WAITING TIME

Does not apply.

1. SPECIAL STORAGE PRECAUTIONS

Keep out of sight and reach of children.

This veterinary medicinal product does not require any special storage conditions. The pipettes should be kept in the outer packaging to prevent loss of solvent or absorption of moisture.

The medicine should only be opened immediately before use.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

1. SPECIAL WARNING(S)

Special warnings for each target species:

To be exposed to fluralaner, parasites must begin feeding on the host; therefore, the risk of spreading communicable diseases cannot be excluded.

Special precautions for use in animals:

Care must be taken to avoid contact with the animal's eyes.

Do not use directly on skin lesions.

Do not bathe or allow your dog to submerge in water or swim in streams for 3 days after treatment.

In the absence of available data, the veterinary medicinal product should not be used in puppies younger than 8 weeks of age and/or weighing less than 2 kg.

The product should not be administered at intervals of less than 8 weeks as safety for shorter intervals has not been tested.

The product is for topical use and should not be taken orally.

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

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This product is harmful if swallowed. Keep the product in the original packaging until use, to

Prevent children from having direct access to the product. A used pipette should be discarded immediately.

In case of accidental ingestion, seek medical advice and show the product package leaflet or label.

This product and the wet skin of a recently treated animal may be mildly irritating to the skin and/or eyes.

Avoid contact with skin and/or eyes, including hand-eye contact. Do not eat, drink or smoke while handling the product. On the day of treatment, do not touch or allow children to touch the application site until it is dry. Hands and skin that has been in contact with the product should be washed thoroughly with soap and water immediately after using the product. In case of contact with eyes, rinse immediately with plenty of water.

The product is highly flammable. Keep away from heat, sparks, open flames or other sources of ignition.

ignition.

The active ingredient in the product is highly lipophilic and binds to the skin and can also bind to surfaces after product spills.

Therefore, the following precautions are recommended:

• Wear appropriate gloves when handling or applying the product to dogs and cats.
• In case of spillage, on surfaces such as a table or floor, remove excess product.

using a paper towel and cleaning the area with detergent.

Do not allow treated animals to come into contact with untreated animals until the application site has healed.

it is completely dry.

Use during pregnancy, lactation or fertility:

It can be used in breeding animals, pregnant and lactating females.

Interactions with other medicinal products and other forms of interaction:
They don't know each other.

Fluralaner is bound to plasma proteins and may compete with other drugs with high plasma levels.

binding, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin. Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at expected maximum plasma concentrations did not reduce protein binding of fluralaner, carprofen or warfarin.

During clinical trials, no interactions occurred between Bravecto spot-on for dogs and other products.

routinely used veterinary medicinal products.

Overdose:

No adverse reactions were observed following administration to chickens aged 8–9 weeks and weighing 2.0–

3.7 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg

fluralaner/kg body weight) at intervals three times shorter than recommended (8-week intervals).

Safety has been demonstrated in breeding, pregnant and lactating animals treated with a

dose three times higher than the recommended dose

This veterinary medicinal product was well tolerated in Collies with a drug resistance deficiency.

of proteins-1 (MDR1-/-) after single oral administration of 3 times the recommended dose (168 mg/

kg body weight).

Incompatibilities:
They don't know each other.

1. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be thrown away in wastewater or household waste.

Ask your veterinarian for information on how to dispose of unused medicines.

are no longer necessary. These measures contribute to environmental protection.

1. DATE ON WHICH THE PROSPECTUS WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency.

drugs

1. OTHER INFORMATION

The product contributes to the control of flea populations in the environment in areas to which treated dogs have access. The onset of effect is 12 hours after attachment for fleas (C. felis) and 48 hours after attachment for ticks (I. ricinus).

Unit dose pipette made of aluminium foil/polypropylene laminate closed with a HDPE cap and packed in an aluminium foil laminate sachet. Each carton contains 1 or 2 pipettes. Not all pack sizes may be marketed.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Presentation type: Pipette

Action: Ticks, Fleas

Dog Weight: 2-4.5 KG

Pieces Set: 1 piece

Brand Name: Bravecto

Product Code: 8713184151421

Quantity: 1 Piece