Product Details - BRAVECTO®

Dogs

Product Class

FOR ANIMAL USE ONLY

BRAVECTO®

For Miniature Dogs     (2 – 4,5 kg)
For Small Dogs           (> 4,5 – 10 kg)
For Medium Dogs       (> 10 – 20 kg)
For Large Dogs           (> 20 – 40 kg)
For Extra-Large Dogs  (> 40 – 56 kg)

Reg. No. G4083 (Act 36/1947)
Namibia Reg. No. V14/18.3.10/1259 NS0

This product may only be sold by persons registered in terms of section 23(1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982).

INDICATIONS
For the treatment and prevention of tick, flea and mite infestations in dogs. Bravecto® kills adult, as well as juvenile ticks (larvae and nymphs). Bravecto® can be used as part of a treatment strategy for Flea Allergy Dermatitis (FAD). For the treatment of Demodicosis caused by Demodex spp. mites. In a controlled trial, treatment with fluralaner resulted in the complete removal of Demodex spp. mites from treated dogs.

COMPOSITION
Contains fluralaner equivalent to 25 to 56 mg/kg body weight.
Each chewable tablet contains:
Miniature Dogs:           112,5 mg
Small Dogs:                  250 mg
Medium Dogs:              500 mg
Large Dogs:                1 000 mg
Extra-Large Dogs:      1 400 mg

CAUTION

STORAGE
Store at or below 30 °C in a cool, dry place.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Fluralaner is an acaricide and insecticide. It is efficacious against ticks (Ixodes spp., Dermacentor spp., Haemaphysalis elliptica and Rhipicephalus sanguineus) and fleas (Ctenocephalides spp.) on dogs. Fluralaner is systemically active on target parasites. Contact activity against ticks and fleas is of minor relevance. Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor). In a molecular on target study, fluralaner is not affected by dieldrin resistance.
In vitro, fluralaner overcomes resistance against amidines, organophosphates, cyclodienes, macrocyclic lactones, phenylpyrazoles, benzophenyl ureas, pyrethroids and carbamates.
In vivo, fluralaner is highly effective against fleas proven to be less susceptible to phenylpyrazole insecticides.

Pharmacokinetic properties
Following oral administration, fluralaner is readily absorbed reaching maximum plasma concentrations within 1 day. Food enhances the absorption. Fluralaner is systemically distributed and reaches the highest concentrations in the visceral fat, followed by liver, kidney and muscle. The prolonged persistence and slow elimination from plasma (t½ = 12 days) and the lack of extensive metabolism provide effective concentrations of fluralaner for the duration of the inter-dosing interval, ensuring efficacy for 12 weeks. The major route of elimination is the excretion of unchanged fluralaner in faeces (~ 90 % of the dose). Renal clearance is the minor route of elimination.

WARNINGS

  • Safety in puppies less than 8 weeks of age and/or dogs weighing less than 2 kg has not been established.
  • Keep the product in the original packaging until use.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Can be used in breeding, pregnant and lactating dogs.
  • Bravecto® is well tolerated in MDR1 dogs following oral administration.
  • Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • Do not eat, drink or smoke while handling the product.
  • Wash hands thoroughly with soap and water immediately after use of the product.
  • Do not store with food, drinks, medication or household products.

ADVERSE REACTIONS
In a well-controlled U.S. field study, which included 294 dogs, there were no serious adverse reactions. Bravecto® was administered to 224 dogs every 12 weeks and 70 dogs were administered an oral active control every 4 weeks and were provided with a tick collar. All potential adverse reactions were recorded in dogs treated with Bravecto® over a 182-day period and in dogs treated with the active control over an 84-day period. The most frequently reported adverse reaction in dogs in the Bravecto® and active control groups was vomiting.

Percentage of dogs with adverse reactions in the field study;

Adverse reactionBravecto® group: Percentage of dogs with the adverse reaction during the 182-day study
(n = 224 dogs)
Active Control Group: Percentage of dogs with the adverse reaction during the 84-day study
(n = 70 dogs)
Vomiting7,114,3
Decreased Appetite6,70,0
Diarrhoea4,92,9
Lethargy5,47,1
Polydipsia1,84,3
Flatulence1,30,0

 

In a well-controlled laboratory dose confirmation study, 1 dog developed oedema and hyperaemia of the upper lips within 1 hour of receiving Bravecto®. The oedema improved progressively through the day and had resolved without medical intervention by the next morning.

DIRECTIONS FOR USE

  • Administer tablets at or around the time of feeding for maximum effectiveness.
  • It can be mixed with food or given by hand since it is very palatable.
  • For optimal control of tick and flea infestation, Bravecto® should be administered at a 12 week interval.
  • Bravecto® can be administered all year round.

DOSAGE

Weight (kg)Tablet size
2,0 - 4,5112,5 mg for miniature dogs
> 4,5 - 10250 mg for small dogs
> 10 - 20500 mg for medium dogs
> 20 - 401 000 mg for large dogs
> 40 - 561 400 mg for extra-large dogs

 

Within each weight range a whole tablet must be used.
For dogs weighing more than 56 kg, use a combination of 2 tablets that most closely matches the body weight.

OVERDOSE
Bravecto® was well tolerated following oral administration to puppies aged between 8 and 9 weeks and weighing between 2,0 and 3,6 kg at doses of up to 56 mg, 168 mg and 280 mg fluralaner/kg body weight (equivalent to 1, 3 and 5 times the maximum expected clinical dose) on 3 occasions at 8-week intervals. No treatment-related adverse effects were observed.
There were no findings on reproductive performance and offspring viability when up to 168 mg/kg of fluralaner (equivalent to 3 times the maximum treatment dose) was administered orally to Beagle dogs.

EFFICACY
Bravecto® was shown to be effective* against fleas and various tick species.
* Efficacy > 90 to 95 %

Bravecto® is indicated for the treatment of the following:
TICKS: (Ixodes ricinus, Ixodes hexagonus, Ixodus scapularis, Dermacentorreticulatus, Dermacentor variabilis, Haemaphysalis elliptica and Rhipicephalus sanguineus)
Directly after treatment, at least 90 % of ticks on dogs are killed within 8 hours. During the whole treatment interval, at least 90 % of ticks on dogs are killed within 12 hours.

FLEAS: (Ctenocephalides felis)
Directly after treatment, at least 95 % of fleas are killed within 8 hours. During the whole treatment interval, at least 95 % of fleas on dogs are killed within 12 hours.
Effect on immature stages
The product kills adult as well as juvenile ticks (larvae, nymphs). Newly emerged fleas on a dog are killed before viable eggs are produced. An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.
Control of flea infestations and Flea Allergy Dermatitis (FAD)
The flea life cycle is broken due to the rapid onset action and long lasting efficacy against adult fleas on the animal and the absence of viable egg production. Bravecto® effectively controls environmental flea populations in areas to which the dog has access. Bravecto® can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

IDENTIFICATION
Light to dark brown chewable tablet with a smooth or slightly rough surface and circular shape. Some marbling, speckles or both may be visible.

PRESENTATION
Packaged in an aluminium foil blister with aluminium foil lid stock in an outer carton.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet GmbH
Siemensstrasse 107
1210 Vienna
Austria

DATE OF PUBLICATION OF THIS PACKAGE INSERT
17 January 2017

Zimbabwe Reg. No. E 2017/80.16.00/9754
Veterinary Classification: 801600
Distribution Category: V.M.G.D