Bravecto 1000 mg Spot-on Solution for Large Dogs (>20 – 40 kg)

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Fluralaner

Dostupné z:

MSD Animal Health UK Limited

ATC kód:

QP53BE02

INN (Medzinárodný Name):

Fluralaner

Forma lieku:

Spot-on solution

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Ectoparasiticide

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2016-05-17

Súhrn charakteristických

Revised: January 2024
AN: 02555/2022
Version 1 (last updated 16/06/22) – do not delete
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto 1,000 mg spot-on solution for large dogs (>20 – 40 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains 280 mg fluralaner.
Each pipette delivers:
PIPETTE CONTENT
(ML)
FLURALANER
(MG)
for large dogs >20 – 40 kg
3.57
1,000
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on-solution.
Clear colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of tick and flea infestations in dogs.
This veterinary medicinal product is a systemic insecticide and
acaricide that
provides:
-
immediate and persistent flea (_Ctenocephalides felis _and_
Ctenocephalides canis_)
killing activity for 12 weeks, and
-
immediate and persistent tick (_Ixodes ricinus, Rhipicephalus
sanguineus _and_ _
_Dermacentor reticulatus_) killing activity for 12 weeks_. _
Fleas and ticks must attach to the host and commence 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).
For the treatment of demodicosis caused by _Demodex_ _canis_.
For the treatment of sarcoptic mange (_Sarcoptes scabiei _var_.
canis_) infestation.
Revised: January 2024
AN: 02555/2022
Version 1 (last updated 16/06/22) – do not delete
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4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
Unnecessary use of antiparasitics or use deviating from the
instructions given may
increase the resistance selection pressure and lead to reduced
efficacy. The decision
to use