Bravecto® Spot On

A Spot-On product for the treatment and prevention of tick, flea and mite infestations in dogs and cats.
In cats, Bravecto® Spot-On provides immediate and persistent flea and tick activity for 3 months.
In dogs, Bravecto® Spot-On provides immediate and persistent tick activity for 4 months and flea activity for 6 months. Bravecto® Spot-On is well tolerated in MDR1 dogs.

Download the Bravecto® Spot-On owners brochure below.

FOR ANIMAL USE ONLY

BRAVECTO® SPOT-ON

Reg. No. G4292 (Act 36/1947)

Namibia Reg. No. V19/18.3.10/1441 [NS0]

INDICATIONS

For the treatment and prevention of tick, flea and mite infestations in dogs and cats.

Bravecto® Spot-On can be used as part of a treatment strategy for Flea Allergy Dermatitis (FAD). For the treatment of mange caused by Demodex spp. and Sarcoptes scabiei mites in dogs. For the treatment of Otodectes spp. mite infestations in dogs and cats.

In cats, Bravecto® Spot-On provides immediate and persistent flea and tick killing activity for 3 months.

In dogs, Bravecto® Spot-On provides immediate and persistent tick killing activity for 4 months and flea killing activity for 6 months. Bravecto® Spot-On is well tolerated in MDR1 dogs.

A single treatment prevents Dipylidium caninum transmission from infected fleas to susceptible dogs for 12 weeks.

COMPOSITION

Each 1 mℓ of Bravecto® Spot-On contains 280 mg fluralaner.

Each pipette delivers:

Miniature dogs: 112,5 mg fluralanerSmall cats: 112,5 mg fluralaner
Small dogs: 250 mg fluralanerMedium cats: 250 mg fluralaner
Medium dogs: 500 mg fluralanerLarge cats: 500 mg fluralaner
Large dogs: 1 000 mg fluralaner
Extra-large dogs: 1 400 mg fluralaner

CLINICAL PHARMACOLOGY

Peak fluralaner concentrations are achieved between 7 and 42 days following topical administration and the elimination half-life ranges between 14 and 29 days. The bioavailability of fluralaner following oral and topical administration is approximately 25 %.

PHARMACODYNAMIC PROPERTIES

Fluralaner is an acaricide and insecticide. It is efficacious against ticks, fleas and mites.

Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives.

Fluralaner is an inhibitor of parts of the arthropod nervous system. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor).

CAUTION

STORAGE INSTRUCTIONS

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

WARNINGS

  • Handle with caution.
  • For cats, safety has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
  • For dogs infected with tapeworm, we recommend a suitable tapeworm treatment be used.
  • Do not use in the case of hypersensitivity to the active substance or to any of the excipients.
  • Parasites need to start feeding on the host to become exposed to fluralaner; therefore, the risk of the transmission of parasite-borne diseases cannot be excluded but is reduced by the speed of efficacy.
  • Care should be taken to avoid contact with the eyes of the animal.
  • Do not use directly on skin lesions.
  • Dogs can be washed/shampooed 3 days after treatment.
  • Safety in puppies less than 8 weeks old and/or dogs weighing less than 2 kg has not been established.
  • Safety in kittens less than 9 weeks old and/or cats weighing less than 1,2 kg has not been established.
  • The product should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.
  • Keep the product in the original packaging until use.
  • Do not have contact with the animal or allow children to have contact with the animal until the application site is dry.
  • The product is highly flammable. Keep away from heat, sparks, open flames or other sources of ignition.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • 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

  • For topical use only. Avoid oral ingestion.
  • Do not eat, drink or smoke while handling the product.
  • Wash hands thoroughly with soap and water immediately after the product has been used. If skin contact does occur, wash the affected area immediately with water. In some cases, water is not sufficient to remove the product spilled on the fingers. If a sticky residue persists on the skin after washing with water, then this can be removed using household items containing organic solvents [e.g., rubbing alcohol (ethanol, isopropyl alcohol) or nail polish remover (acetone)] applied gently with a swab.
  • Do not store with food, drinks, medication or household products.
  • Medicines should not be disposed of via wastewater or household waste but in accordance with the National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008). These measures should help to protect the environment.

INTERACTIONS

Fluralaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the coumarin derivative warfarin. Incubation of fluralaner in the presence of carprofen or warfarin in dog plasma at maximum expected plasma concentrations did not reduce the protein binding of fluralaner, carprofen or warfarin.

During laboratory and clinical field testing, no interactions between Bravecto® Spot-On and routinely used veterinary medicinal products were observed.

ADVERSE REACTIONS

Commonly observed adverse reactions in clinical trials were mild and transient skin reactions at the application site (1,2 % of treated dogs and 2,2 % of treated cats).

Cat’s skin reactions were such as erythema and pruritus (most likely due to a transient discomfort) or alopecia (secondary effect due to scratching or licking). As a result of transient discomfort shortly after administration, the following signs were observed: apathy/tremors/anorexia (0,9 % of treated cats) or vomiting/hypersalivation (0,4 % of treated cats). Based on post-registration experience, convulsions have very rarely been reported, (less than 1 in 10 000 animals treated).

Emesis, lethargy, inappetence, muscle tremors, ataxia and convulsions have been reported very rarely in spontaneous reports after the use of this product (less than 1 animal in 10 000 animals treated).

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

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Bravecto® Spot-On should be administered in accordance with the following table (corresponding to a dose of between 25 and 56 mg fluralaner/kg body weight in dogs and between 40 and 94 mg fluralaner/kg body weight in cats within one weight band):

Weight of dog/cat (kg)Pipette size to be usedVolume (m)Fluralaner (mg)
2 – 4,5Miniature dogs0,4112,5
> 4,5 – 10Small dogs0,89250
> 10 – 20Medium dogs1,79500
> 20 – 40Large dogs3,571 000
> 40 – 56Extra-large dogs5,01 400
> 56The appropriate combination of pipettes should be used.
1,2 – 2,8Small cats0,4112,5
> 2,8 – 6,25Medium cats0,89250
> 6,25 – 12,5Large cats1,79500

For optimal control of tick infestation, Bravecto® Spot-On should be administered every 3 months for cats and every 4 months for dogs.

For optimal control of flea infestation, Bravecto® Spot-On should be administered every 3 months for cats and every 6 months for dogs.

Within each weight range, a whole pipette must be used.

For dogs weighing more than 56 kg, use a combination of 2 pipettes that most closely matches the body weight.

For cats weighing more than 12,5 kg, use a combination of 2 pipettes that most closely matches the body weight.          

Method of administration

Step 1

Open the sachet and remove the pipette immediately before use. The pipette should be held by the upper part of the tail base (crimped end) or by the upper rigid portion below the cap in an upright position (tip up) before opening it. The cap should be rotated clockwise or counterclockwise in one full turn. The cap will stay on the pipette; it is not possible to remove it. The pipette is open and ready for application when the breaking of the seal is felt.

Step 2

The dog/cat should be standing or lying with its back horizontally during application. Part the fur at the administration site. Place the pipette tip vertically against the skin between the shoulder blades of the dog or on the base of the skull of the cat.

Step 3

Dogs:

Squeeze the pipette gently and apply the entire contents directly to the dog’s skin in one go (when volume is small) or several spots along the dog’s dorsal line from the shoulder to the base of the tail. Avoid applying an excessive amount of solution at any one spot that could cause some of the solution to run or drip off the dog.

Cats

Squeeze the pipette gently and apply the entire contents directly to the cat’s skin. The product should be applied in one spot (cats up to 6,25 kg body weight) at the base of the skull and in two spots on cats greater than 6,25 kg body weight. If 2 spots are required, apply both spots to the base of the skull.

It is important to deliver the solution onto an area that cannot be easily licked by the cat. As cats are fastidious groomers, they may inadvertently ingest product if easily reached. Ingestion may cause adverse reactions and will remove product from the coat. If multiple cats are treated and may mutually groom, it is recommended that cats are separated while product dries.

OVERDOSE

Dogs

Safety was demonstrated in puppies aged between 8 and 9 weeks and weighing between 2,0 and 3,7 kg treated with overdoses of up to 5 times the maximum recommended dose on 3 occasions at shorter intervals than recommended (8-week intervals).

Safety was demonstrated in breeding, pregnant and lactating dogs treated with overdoses of up to 3 times the maximum recommended dose.

Bravecto® Spot-On was well tolerated in Collie dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose.

Cats

Safety was demonstrated in kittens aged between 9 and 13 weeks and weighing between 0,9 and 1,9 kg treated with overdoses of up to 5 times the maximum recommended dose on 3 occasions at shorter intervals than recommended (8-week intervals).

Oral uptake of Bravecto® Spot-On at the maximum recommended dose was, both locally and systemically, well tolerated in cats, apart from some self-limiting salivation and coughing immediately after administration.

In cats, safety has not been established during pregnancy and lactation.

EFFICACY

Bravecto® Spot-On was shown to be effective against ticks, fleas and mites.

It is a systemic insecticide and acaricide.

Cats: the product provides immediate and persistent flea and tick killing activity for 3 months.

Dogs: the product provides immediate and persistent tick killing activity for 4 months and flea killing activity for 6 months.

Ticks and fleas must attach to the host and commence feeding in order to be exposed to the active substance. The onset of effect is within 8 hours.

Bravecto® Spot-On is efficacious for the treatment of the following:

Ticks

Dogs: Ixodes ricinus, Rhipicephalus sanguineus, Haemaphysalis elliptica and Dermacentor reticulatus.

Cats: Ixodes ricinus and Haemaphysalis elliptica.

Directly after treatment, at least 90 % of ticks on the animals are killed within 8 hours. During the whole treatment interval, at least 90 % of ticks on the animals are killed within 12 hours.

Fleas

Dogs: Ctenocephalides felis and Ctenocephalides canis.

Cats: 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.

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® Spot-On effectively controls environmental flea populations in areas to which the animals have access.

Effect on immature stages

The product kills adult as well as juvenile ticks (larvae, nymphs). Newly emerged fleas on animals 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.

Mites

Dogs: Mange caused by Demodex spp. and Sarcoptic mange mites. For the treatment of Otodectes spp. mite infestations.

Cats: Otodectes spp.

PRESENTATION

Unit dose pipette made of laminated aluminium/polypropylene foil containing a colourless to yellowish solution, practically free from visible particles closed with cap and packed in a sachet. Each carton box contains 1 or 2 pipettes.

MANUFACTURER

Intervet Productions

Rue de Lyons

27460 Igoville

France

REGISTRATION HOLDER                                      

Intervet South Africa (Pty) Ltd.                           

20 Spartan Road, Spartan                                      

1619, RSA                                                                      

Tel: +27 (0) 11 923 9300                                          

E-mail: msdahza@merck.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

17 August 2023

SLEGS VIR DIEREGEBRUIK

BRAVECTO® SPOT-ON SOLUTION

Reg. Nr. G4292 (Wet 36/1947)

Namibië Reg. Nr. V19/18.3.10/1441 [NS0]

INDIKASIES

Vir die behandeling en voorkoming van vlooi-, bosluis- en mytinfestasies in honde en katte. Bravecto® Spot-On kan gebruik word as deel van ‘n behandelingstrategie vir Vlooi Allergiese Dermatitis (VAD). Vir die behandeling van skurfte wat veroorsaak word deur Demodex spp. en Sarcoptes scabiei myte by honde. Vir die behandeling van Otodectes spp. mytinfestasies in honde en katte.

In katte het Bravecto® Spot-On ‘n onmiddellike en aanhoudende vlooi- en bosluisdodende aktiwiteit vir 3 maande.

In honde het Bravecto® Spot-On ‘n onmiddellike en aanhoudende bosluisdodende aktiwiteit vir 4 maande asook ‘n vlooidodende aktiwiteit vir 6 maande. Bravecto® Spot-On word goed verdra in MDR1 honde.

‘n Enkele behandeling verhoed dat Dipylidium caninum-oordrag vanaf besmette vlooie na vatbare honde vir 12 weke voorkom.

SAMESTELLING

Elke 1 mℓ Bravecto® Spot-On bevat 280 mg fluralaner.

Elke pipet verskaf:

Miniatuur honde: 112,5 mg fluralanerKlein katte: 112,5 mg fluralaner
Klein honde: 250 mg fluralanerMedium katte: 250 mg fluralaner
Medium honde: 500 mg fluralanerGroot katte: 500 mg fluralaner
Groot honde: 1 000 mg fluralaner
Ekstra Groot honde: 1 400 mg fluralaner

KLINIESE FARMAKOLOGIE

Piek fluralanerkonsentrasies word tussen 7 en 42 dae na topikale toediening bereik en die eliminasie halfleeftyd wissel tussen 14 en 29 dae. Die biobeskikbaarheid van fluralaner na orale- en topikale toediening is ongeveer 25 %.

FARMAKODINAMIESE EIENSKAPPE

Fluralaner is ‘n myt- en insekdoder. Dit is effektief teen bosluise, vlooie en myte.

Fluralaner is vir sistemiese gebruik en behoort aan die klas isoksasolien-vervangde bensamied-derivate.

Fluralaner is ‘n inhibeerder van ‘n gedeelte van die geleedpotige se senuweestelsel deur antagonisties op die ligandbeheerde chloriedkanale (gamma-aminobutuursuur (GABA)-reseptor en glutamaat-reseptor) te werk.

VERSIGTIG

BERGINGSINSTRUKSIES

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

WAARSKUWlNGS

  • Hanteer versigtig.
  • Vir katte is die veiligheid gedurende dragtigheid en laktasie nog nie vasgestel nie. Gebruik slegs volgens die voordeel/risiko-assessering deur die verantwoordelike veearts.
  • Vir honde wat met lintwurm besmet is, beveel ons aan dat ‘n geskikte lintwurmbehandeling gebruik word.
  • Moenie gebruik in die geval van hipersensitiwiteit teenoor die aktiewe bestanddele of enige van die hulpmiddels nie.
  • Parasiete moet begin voed op die gasheer om blootgestel te word aan fluralaner; daarom kan die risiko van parasietoorgedraagde siektes nie uitgesluit word nie, maar dit kan verminder word deur die snelheid van effektiwiteit.
  • Sorg moet gedra word om kontak met die dier se oë te vermy.
  • Moenie direk op velletsels gebruik nie.
  • Honde kan gewas/gesjampoe word 3 dae na behandeling.
  • Veiligheid in hondjies jonger as 8 weke en/of honde wat minder as 2 kg weeg is nog nie bepaal nie.
  • Veiligheid in katjies jonger as 9 weke en/of katte wat minder as 1,2 kg weeg is nog nie bepaal nie.
  • Die produk moenie toegedien word teen intervalle korter as 8 weke nie, aangesien die veiligheid van korter intervalle nie getoets is nie.
  • Hou die produk in die oorspronklike verpakking tot voor gebruik.
  • Moenie diere aanraak of kinders toelaat om die diere aan te raak totdat die toedieningsarea droog is nie.
  • Die produk is hoogs vlambaar. Hou weg van hitte, vonke, oop vlamme en ander vorms van ontbranding.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie middel breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. lndien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

VOORSORGMAATREëLS

  • Vir topikale gebruik alleenlik. Vermy orale inname.
  • Moenie eet, drink of rook terwyl die produk hanteer word nie.
  • Was hande deeglik met seep en water direk nadat die produk gebruik is. Indien velkontak voorkom, was die betrokke area dadelik met water. In sommige gevalle is water nie voldoende om die produk wat op die vingers gespat het, te verwyder nie. Indien ‘n taai residu agterbly op die vel nadat dit met water gewas is, kan dit verwyder word deur gebruik te maak van huishoudelike items wat organiese oplosmiddels bevat, [bv. chirurgiese alkohol (etanol, isopropielalkohol) of naellakverwyderaar (asetoon)].
  • Moenie saam met kos, drank, medikasie of huishoudelike produkte stoor nie.
  • Medisyne moenie weggedoen word via afvalwater of huishoudelike afval nie maar volgens die Nasionale Omgewingsbestuur: Wet op Afval, 2008 (Wet Nr. 59 van 2008).
  • Hierdie maatreëls behoort te help om die omgewing te beskerm.

INTERAKSIES

Fluralaner is hoogs plasmaproteïengebonde en kan kompeteer met ander hoogs gebonde middels soos nie-steroïede anti-inflammatoriese middels (NSAIMs) en die kumarienderivaat van warfarin. lnkubasie van fluralaner in die teenwoordigheid van karprofen of warfarin in die hondplasma teen maksimum verwagte plasmakonsentrasies, het nie die proteïenbinding van fluralaner, karprofen of warfarin verminder nie.

Gedurende laboratorium- en kliniese veldtoetse is geen interaksie tussen Bravecto® Spot­On en dieremedisyne wat gereeld gebruik word, waargeneem nie.

NEWEEFFEKTE

Newe-effekte wat algemeen waargeneem is in kliniese proewe, was lig, en verbygaande velreaksies by die toedieningspunt (1,2 % van die behandelde honde en 2,2 % van behandelde katte).

Katte se velreaksies het eriteem en pruritus (waarskynlik as gevolg van verbygaande ongerief) of alopesie (sekondêre effek weens krap of lek) ingesluit. As gevolg van verbygaande ongerief, is die volgende tekens na toediening waargeneem: apatie/bewerigheid/anoreksie (0,9 % van die behandelde katte) of braking/hipersalivering (0,4 % van die behandelde katte). Gebaseer op na-registrasie ervaring, is stuiptrekkings baie selde aangemeld, (minder as 1 uit 10 000 diere wat behandel is).

Braking, lusteloosheid, verlies van aptyt, spiertrillings, ataksie en stuiptrekkings is baie selde in spontane verslae aangemeld na gebruik van hierdie produk (minder as 1 uit 10 000 diere wat behandel is).

As u enige ernstige gevolge of ander effekte wat nie in hierdie voubiljet genoem word nie

waarneem, stel asseblief u veearts in kennis.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

Bravecto® Spot-On moet in ooreenstemming met die volgende tabel toegedien word (wat ooreenstem met ‘n dosis van tussen 25 en 56 mg fluralaner/kg liggaamsgewig in honde en tussen 40 en 94 mg fluralaner/kg liggaamsgewig in katte binne een gewigsband):

Gewig van hond/kat (kg)Pipetgrootte vir gebruikVolume (m)Fluralaner (mg)
2 – 4,5Miniatuur honde0,4112,5
> 4,5 – 10Klein honde0,89250
> 10 – 20Medium honde1,79500
> 20 – 40Groot honde3,571 000
> 40 – 56Ekstra Groot honde5,01 400
> 56Die gepaste kombinasie van pipette moet gebruik word.
1,2 – 2,8Klein katte0,4112,5
> 2,8 – 6,25Medium katte0,89250
> 6,25 – 12,5Groot katte1,79500

Vir optimale beheer van bosluisinfestasie, moet Bravecto® Spot-On elke 3 maande vir katte en elke 4 maande vir honde, toegedien word.

Vir optimale beheer van vlooi-infestasie, moet Bravecto® Spot-On elke 3 maande vir katte en elke 6 maande vir honde toegedien word.

Binne elke gewigsreeks moet ‘n hele pipet gebruik word.

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

Katte wat meer as 12,5 kg weeg, moet ‘n kombinasie van 2 pipette gebruik wat die naaste

aan die liggaamsgewig is.

Toedieningsmetode

Stap 1

Onmiddellik voor gebruik, maak die sakkie oop en verwyder die pipet. Die pipet moet vasgehou word op die boonste gedeelte van die stertbasis (geriffelde punt) of deur die boonste stewige gedeelte onder die doppie in ‘n regop posisie te hou (doppie boontoe) voordat dit oopgemaak word. Die doppie moet kloksgewys of antikloksgewys gedraai word vir een volle draai. Die doppie sal op die pipet bly; dit is nie moontlik om dit te verwyder nie. Die pipet is oop en gereed vir toediening wanneer die verbreking van die seël gevoel word.

Stap 2

Die hond/kat moet staan of met hulle rug horisontaal lê tydens toediening. Skei die hare by die toedieningsplek. Plaas die pipetpunt vertikaal teen die vel tussen die skouerblaaie van die hond of op die basis van die skedel van die kat.

Stap 3

Honde

Druk die pipet liggies en dien die hele inhoud toe direk op die hond se vel op een plek (wanneer die volume klein is) of op ‘n paar plekke langs die hond se dorsale lyn van die skouer tot by die basis van die stert. Vermy om ‘n oormatige hoeveelheid oplossing op een plek toe te dien, wat kan veroorsaak dat die oplossing van die hond afloop of afdrup.

Katte

Druk die pipet liggies en dien die volle inhoud direk op die kat se vel toe. Die produk moet toegedien word op een plek, (katte wat tot en met 6,25 kg liggaamsgewig weeg), aan die onderkant van die skedel of twee plekke (katte wat meer as 6,25 kg liggaamsgewig weeg). As twee plekke nodig is, dien albei toe aan die onderkant van die skedel.

Dit is belangrik om die oplossing toe te dien op ‘n area wat nie maklik deur die kat gelek kan word nie. Aangesien katte puntenerige versorgers is, kan hulle per ongeluk die produk inneem as dit te maklik bereik kan word. lnname mag ongewenste reaksies veroorsaak en sal die produk van die pels verwyder. lndien meer katte behandel word wat mekaar onderling versorg, word aanbeveel dat katte geskei word terwyl die produk droog word.

OORDOSERING

Honde

Veiligheid is gedemonstreer in hondjies tussen die ouderdom van 8 en 9 weke en met ‘n gewig van tussen 2,0 en 3,7 kg wat behandel is met tot 5 keer die maksimum aanbevole dosis by drie geleenthede en met korter tussenposes as die aanbevole, 8-week intervalle. Veiligheid is gedemonstreer in teel-, dragtige- en lakterende honde behandel met oordosisse van tot 3 keer die maksimum aanbevole dosis.

Bravecto® Spot-On is goed verdra in Kolliehonde met ‘n gebrekkige multi-weerstand-proteïen-1 (MDR1 -/-) na ‘n enkele orale toediening teen 3 keer die aanbevole dosis.

Katte

Veiligheid is gedemonstreer in katjies tussen die ouderdom van 9 en 13 weke en met ‘n gewig van tussen 0,9 en 1,9 kg behandel met oordosisse van tot 5 keer die maksimum aanbevole dosis by 3 geleenthede, met korter tussenposes as die aanbevole, 8-week intervalle.

Orale opname van Bravecto® Spot-On teen die maksimum aanbevole dosis word beide lokaal en sistemies, goed verdra in katte, afgesien van sommige selfbeperkende speekselafskeiding en hoesgevalle onmiddellik na toediening.

In katte is die veiligheid gedurende dragtigheid en laktasie nog nie vasgestel nie.

DOELTREFFENDHEID

Daar is bewys dat Bravecto® Spot-On effektief teen bosluise, vlooie en myte gebruik kan word.

Dit is ‘n sistemiese insek- en mytdoder.

In katte: Die produk lewer onmiddellike en aanhoudende vlooi- en bosluisdodende aktiwiteit vir 3 maande.

In honde: Die produk lewer onmiddellike en aanhoudende bosluisdodende aktiwiteit vir 4 maande, en vlooidodende aktiwiteit vir 6 maande.

Bosluise en vlooie moet aan die gasheer vasheg en begin voed om in aanraking met die aktiewe bestanddeel te kom. Die aanvangseffek is binne 8 ure.

Bravecto® Spot-On is effektief vir die behandeling van die volgende:

Bosluise

Honde: lxodes ricinus, Rhipicephalus sanguineus, Haemaphysalis elliptica en Dermacentor reticulatus.

Katte: Ixodes ricinus en Haemaphysalis elliptica.

Direk na behandeling, word 90 % van die bosluise binne 8 uur gedood. Tydens die totale behandelingsinterval, word 90 % van die bosluise op die diere binne 12 uur gedood.

Vlooie

Honde: Ctenocephalides felis en Ctenocephalides canis.

Katte: Ctenocephalides felis.

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

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® Spot-On beheer vlooipopulasies in die omgewing effektief in areas waartoe die diere toegang het.

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.

Myte

Honde: Skurfte veroorsaak deur Demodex spp. en Sarcoptes skurftemyte. Vir die behandeling van Otodectes spp. mytbesmettings.

Katte: Otodectes spp.

AANBIEDING

Eenheidsdosispipet gemaak van gelamineerde aluminium/polipropileenfoelie met ‘n kleurlose tot gelerige oplossing, feitlik vry van sigbare deeltjies, gesluit met ‘n doppie en verpak in ‘n sakkie. Elke kartonboks bevat 1 pipet.

VERVAARDIGER

Intervet Productions

Rue de Lyons

27460 Igoville

France

REGISTRASIEHOUER                                             

Intervet South Africa (Pty) Ltd.                           

Spartanweg 20, Spartan                                         

1619, RSA                                                                      

Tel: +27 (0) 11 923 9300                                          

E-pos: msdahza@merck.com

www.msd-animal-health.co.za

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

17 Augustus 2023