BRAVECTO® - MSD Animal Health South Africa

For the treatment and prevention of tick, flea and mite infestations in dogs. Bravecto® kills
adult, and 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. and Sarcoptic mange mites.

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

INDICATIONS

For the treatment and prevention of tick, flea and mite infestations in dogs. Bravecto^® kills adult, and 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. and Sarcoptic mange mites. In a controlled trial, treatment with fluralaner resulted in the complete removal of Demodex spp. mites from treated dogs.

For the treatment of Otodectes spp. ear mite infestations.

The flea insecticidal efficacy of Bravecto^® (fluralaner) significantly reduces the likelihood of Dipylidium caninum (tapeworm) transmission from fleas to susceptible dogs throughout the 84 days following a single treatment, by controlling fleas on dogs and lowering the flea burden in the dog’s immediate environment.

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.) and mites (Demodex spp., Sarcoptes spp., Otodectes 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 (t_½ = 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

Use with caution in dogs with pre-existing epilepsy.
Safety in puppies less than 8 weeks of age and/or dogs weighing less than 2 kg has not been established.
For dogs infected with tapeworm, it is recommended that a suitable tapeworm treatment be used.
Keep Bravecto^®in the original packaging until use.
Do not use in case of hypersensitivity to fluralaner or to any of the excipients.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Can be used in breeding, pregnant and lactating dogs.
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.
Do not administer at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.

ADVERSE REACTIONS

Commonly observed adverse reactions in clinical trials (1,6 % of treated dogs) were mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling.

Lethargy, muscle tremor, ataxia and convulsion have been reported very rarely in spontaneous reports. Most reported adverse reactions were self-limiting and of short duration.

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

– very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one 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).

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

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.
The chew tablets should not be broken or divided.

DOSAGE

Weight (kg)	Tablet size
2,0 – 4,5	112,5 mg for miniature dogs
> 4,5 – 10	250 mg for small dogs
> 10 – 20	500 mg for medium dogs
> 20 – 40	1 000 mg for large dogs
> 40 – 56	1 400 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.

Bravecto^® was well tolerated in Collies with MDR1-/1 following a single dose at 3 times the recommended dose.

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, Dermacentor reticulatus, 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.

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

Effect on immature stages

Bravecto^®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 alsodemonstrated that very low concentrations of fluralaner stops 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 of 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).

Mites

A single oral administration of Bravecto^® chewable tablets to dogs with Sarcoptes spp. and Otodectes spp.infestations showed a 100 % reduction in live mite counts as well as a complete elimination of live mites 28 days after treatment administration. The treatment resulted in a reduction of skin lesions and increase of hair re-growth.

Single oral administration of Bravecto^® chewable tablets is highly effective against generalised demodicosis caused by Demodex spp., with no mites detectable at 56 and 84 days following treatment.

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

4 April 2020

Zimbabwe Reg. Numbers:
112.5mg: 2017/80.16.00/9754
250 mg: 2019/80.16.00/9787
500 mg: 2019/80.16.00/9788
1000mg: 2019/80.16.00/9789
1400mg: 2019/80.16.00/9790
Pharmacological classification: 801600
Categories for distribution: VMGD

SLEGS VIR DIEREGEBRUIK

BRAVECTO^®

Vir Miniatuur Honde (2 – 4,5 kg)

Vir Klein Honde (> 4,5 – 10 kg)

Vir Medium Honde (> 10 – 20 kg)

Vir Groot Honde (> 20 – 40 kg)

Vir Ekstra Groot Honde (> 40 – 56 kg)

Reg. Nr. G4083 (Wet 36/1947)

Namibië Reg. Nr. V14/18.3.10/1259 NS0

INDIKASIES

Vir die behandeling en voorkoming van vlooi-, bosluis- en mytbesmettings in honde. Bravecto^® maak volwasse bosluise, sowel as onvolwasse bosluise (larwe en nimfe) dood. Bravecto^® kan gebruik word as deel van ‘n behandelingstrategie vir vlooi allergiese dermatitis (VAD). Vir die behandeling van Demodikose. veroorsaak deur Demodex spp. en sarkoptiese skurftemyte. In ‘n goed gekontroleerde studie, het behandeling met fluralaner tot gevolg gehad dat die Demodex spp. myte volledig verwyder was van die behandelde honde. Vir die behandeling van Otodectes spp. oormytbesmettings.

Die vlooi-insekdodende doeltreffendheid van Bravecto^® (fluralaner) verminder aansienlik die waarskynlikheid van Dipylidium caninum (lintwurm) oordrag van vlooie na vatbare honde vir 84 dae na ‘n enkele behandeling, deur die beheer van vlooie op honde en die verlaging van die vlooilas in die hond se onmiddellike omgewing.

SAMESTELLING

Bevat fluralaner ekwivalent aan 25 tot 56 mg/kg liggaamsgewig.

Elke koubaretablet bevat:

Miniatuur Honde: 112,5 mg

Klein Honde: 250 mg

Medium Honde: 500 mg

Groot Honde: 1 000 mg

Ekstra Groot Honde: 1 400 mg

VERSIGTIG

BERGING

Berg teen of benede 30 °C in ŉ koel, droë plek.

FARMAKOLOGIESE WERKING

Farmakodinamiese eienskappe

Fluralaner is ’n akarien- en insekdoder. Dit is effektief teen bosluise ((Ixodes spp., Dermacentor spp., Haemaphysalis elliptica en Rhipicephalus sanguineus) en vlooie (Ctenocephalides spp.) en myte (Demodex spp., Sarcoptes spp., Otodectes spp.) op honde. Fluralaner is sistemies aktief teen teikenparasiete. Kontak-aktiwiteit teen bosluise en vlooie is van min belang. Fluralaner is ‘n potente inhibeerder van dele van die geleedpotiges se senuweestelsel deur antagonisties op die ligandbeheerde chloriedkanale (GABA-reseptor en glutamaat-reseptor) te werk. In ‘n molekulêre teikenstudie, was fluralaner nie geaffekteer deur dieldrienweerstand nie.

In vitro oorkom fluralaner weerstand teen amidiene, organofosfate, siklodiene, makrosikliese laktone, fenielpirasole, bensofenielureas, piretroïede en karbamate.

In vivo is fluralaner hoogs effektief teen vlooie wat minder vatbaar is teen fenielpirasool- insekdoders.

Farmakokinetiese eienskappe

Na orale toediening, word fluralaner goed geabsorbeer en bereik maksimum plasmakonsentrasies binne 1 dag. Voedsel verhoog die absorpsie. Fluralaner word sistemies versprei en bereik die hoogste konsentrasies in die viserale vet, gevolg deur die lewer, niere en spiere. Die verlengde teenwoordigheid, stadige plasma eliminasie (t_½= 12 dae) en die gebrek aan ekstensiewe metabolisme, verskaf effektiewe konsentrasies fluralaner vir die duur van die tussendoseringsinterval. Dit verseker effektiwiteit vir 12 weke. Die hoofroete van eliminasie is die uitskeiding van onveranderde fluralaner in feses (~ 90 % van die dosis). Renale opruiming is ‘n kleiner roete van uitskeiding.

WAARSKUWINGS

Gebruik met versigtigheid by honde wat ly aan epilepsie.
Veiligheid in hondjies jonger as 8 weke oud en/of honde wat minder as 2 kg weeg is nie vasgestel nie.
Vir honde wat besmet is met lintwurm, word dit aanbeveel dat ‘n geskikte lintwurm behandeling gebruik word.
Hou Bravecto^®in die oorspronklike verpakking tot voor gebruik.
Moenie gebruik word in geval van hipersensitiwiteit vir fluralaner of vir enige van die hulpstowwe nie.
HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
Veilig in teel-, dragtige en lakterende honde.
In MDR1 honde word Bravecto^® goed verdra na orale toediening.
Alhoewel hierdie middel breedvoerig onder ŉ wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ŉ veearts en verwittig die registrasiehouer.

VOORSORGMAATREëLS

Moenie eet, drink of rook terwyl die produk hanteer word nie.
Was hande deeglik met seep en water onmiddellik nadat die produk gebruik is.
Moenie saam met voedsel, drank, medikasie of huishoudelike produkte gestoor word nie.
Moenie met intervalle korter as 8 weke toedien nie, aangesien die veiligheid vir korter tussenposes nie getoets is nie.

NEWE-EFFEKTE

Algemene waargenome nadelige reaksies in kliniese toetse (1,6 % van behandelde honde) was ligte en verbygaande gastro-intestinale effekte soos diarree, braking, lusteloosheid en verhoogde speekselafskeiding.

Lusteloosheid, spiersametrekkings, ataksie en stuiptrekkings is baie skaars in spontane (produkveiligheid) verslae berig. Die meeste gemelde newe-effekte was selfbeperkend en van korte duur.

Die frekwensie van nadelige reaksies word gedefinieer met behulp van die volgende verduideliking:

– baie algemeen (meer as 1 in 10 diere wat negatiewe reaksie(s) tydens die verloop van een behandeling toon)

– algemeen (meer as 1 maar minder as 10 in 100 diere)

– ongewoon (meer as 1 maar minder as 10 in 1 000 diere)

– skaars (meer as 1 maar minder as 10 in 10 000 diere)

– baie skaars (minder as 1 in 10 000 diere, insluitend geïsoleerde verslae).

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Vir maksimum effektiwiteit, gee tablette saam of naby etenstyd.
Dit kan met kos gemeng word of per hand gegee word aangesien dit baie smaaklik is.
Vir optimale beheer oor vlooi- en bosluisbesmettings moet Bravecto^® in 12-week intervalle gegee word.
Bravecto^® kan reg deur die jaar toegedien word.
Die koubare tablette mag nie gebreek of verdeel word nie.

DOSIS

Gewig (kg)	Tablet grootte
2,0 – 4,5	112,5 mg vir miniatuur honde
> 4,5 – 10	250 mg vir klein honde
> 10 – 20	500 mg vir medium honde
> 20 – 40	1 000 mg vir groot honde
> 40 – 56	1 400 mg vir ekstra groot honde

’n Hele tablet moet binne elke gewigsgroep gebruik word.

Honde wat meer as 56 kg weeg, moet ’n kombinasie van 2 tablette gebruik wat die naaste aan die liggaamsgewig is.

OORDOSERING

Bravecto^® was goed hanteer na orale toediening deur klein hondjies van tussen 8 en 9 weke oud en wat tussen 2,0 en 3,6 kg weeg, teen dosisse van 56 mg, 168 mg en 280 mg fluralaner/kg liggaamsgewig (ekwivalent aan 1, 3 en 5 keer die maksimum verwagte kliniese dosis) op 3 geleenthede met ‘n 8-week interval. Daar was geen behandelingsverwante ongewenste effekte geïdentifiseer nie.

Na die toediening van 168 mg/kg fluralaner (ekwivalent aan 3 keer die maksimum behandelingsdosis) aan Beagle honde, was daar geen afwyking in voortplantingsprestasie of lewensvatbaarheid van die werpsel gevind nie.

Bravecto^® was goed verdra in Kolliehonde met MDR1- /1 na ‘n enkele dosis teen 3 keer die aanbevole dosis.

DOELTREFFENDHEID

Daar is bewys dat Bravecto^® effektief^*teen vlooie en verskeie bosluisspesies gebruik kan word.

* Effektiwiteit > 90 tot 95 %

Bravecto^® is aangedui vir die behandeling van die volgende:

BOSLUISE: (Ixodes ricinus, Ixodes hexagonus, Ixodus scapularis, Dermacentor reticulatus, Dermacentor variabilis, Haemaphysalis elliptica en Rhipicephalus sanguineus).

Direk na behandeling is ten minste 90 % van die bosluise op die hond binne 8 ure dood. Tydens die hele behandelingsinterval gaan ten minste 90 % van die bosluise op die hond dood binne 12 ure.

VLOOIE: (Ctenocephalides felis)

Direk na behandeling gaan ten minste 95 % van die vlooie op die hond binne 8 ure dood. Tydens die hele behandelingsinterval gaan ten minste 95 % van die vlooie op die hond dood binne 12 ure.

Vlooie en bosluise moet eers aan die gasheer heg en begin eet om blootgestel te word aan die aktiewe bestanddeel.

Effek op onvolwasse stadia

Die produk maak volwasse, sowel as onvolwasse bosluise (larwes en nimfe) dood. Nuut uitgebroeide vlooie op honde gaan dood voordat lewensvatbare eiers geproduseer kan word. ‘n In vitro studie het ook getoon dat baie lae konsentrasies fluralaner, die produksie van lewensvatbare eiers deur vlooie kan verhoed.

Beheer van vlooi-infestasies en vlooi allergiese dermatitis (VAD)

Die vlooi se lewenssiklus word verbreek deur middel van die vinnige werking en die langwerkende effektiwiteit teen die volwasse vlooie op die dier, sowel as die afwesigheid van lewensvatbare eierproduksie. Bravecto^® beheer vlooipopulasies in die omgewing effektief in areas waartoe die hond toegang het. Bravecto^® kan gebruik word as deel van ‘n behandelingstrategie vir vlooi allergiese dermatitis (VAD).

Myte

‘n Enkele orale toediening van Bravecto^®koubare tablette aan honde met Sarcoptes spp. en Otodectes spp. besmetting het ‘n 100 % verlaging in lewende myttellings, sowel as tot ‘n volkome afwesigheid van lewende myte na 28 dae se behandeling gelei. Die behandeling het gelei tot ‘n vermindering van velletsels en toename in teruggroei van hare.

‘n Enkele orale toediening van Bravecto^® koubare tablette is hoogs effektief teen algemene demodikose wat veroorsaak word deur Demodex spp, met geen myte wat op 56 en 84 dae na behandeling voorkom nie.

IDENTIFIKASIE

Ronde, lig- tot donkerbruin koubare tablet met ’n gladde of effens growwe oppervlak. Marmering, spikkels of beide mag sigbaar wees.

AANBIEDING

Verpak in aluminiumfoelie-stolpverpakking met aluminiumfoelie-deksel in ‘n buitenste kartonhouer.

REGISTRASIEHOUER

Intervet South Africa (Pty) Ltd.

Spartanweg 20, Spartan