Bravecto
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-03-2022
Charakterystyka produktu
(SPC)
21-03-2022
Sprawozdanie z oceny publicznego
(PAR)
21-03-2022
Składnik aktywny:
fluralaner
Dostępny od:
Intervet International B.V
Kod ATC:
QP53BE02
INN (International Nazwa):
fluralaner
Grupa terapeutyczna:
Dogs; Cats
Dziedzina terapeutyczna:
Ectoparasiticides for systemic use, Isoxazolines
Wskazania:
Dogs:- For the treatment of tick and flea infestations;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.- For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus. [chewable tablets only]Cats:- For the treatment of tick and flea infestations;The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).- For the treatment of infestations with ear mites (Otodectes cynotis).
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Authorised
Data autoryzacji:
2014-02-11
Ulotka dla pacjenta
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET:
BRAVECTO 112.5 MG CHEWABLE TABLETS FOR VERY SMALL DOGS (2–4.5 KG)
BRAVECTO 250 MG CHEWABLE TABLETS FOR SMALL DOGS (>4.5–10 KG)
BRAVECTO 500 MG CHEWABLE TABLETS FOR MEDIUM-SIZED DOGS (>10–20 KG)
BRAVECTO 1,000 MG CHEWABLE TABLETS FOR LARGE DOGS (>20–40 KG)
BRAVECTO 1,400 MG CHEWABLE TABLETS FOR VERY LARGE DOGS (>40–56 KG)
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 B. V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet GesmbH
Siemensstrasse 107
1210 Vienna
Austria
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto 112.5 mg chewable tablets for very small dogs (2 – 4.5 kg)
Bravecto 250 mg chewable tablets for small dogs (>4.5 – 10 kg)
Bravecto 500 mg chewable tablets for medium-sized dogs (>10 – 20 kg)
Bravecto 1,000 mg chewable tablets for large dogs (>20 – 40 kg)
Bravecto 1,400 mg chewable tablets for very large dogs (>40 – 56 kg)
fluralaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each chewable tablet of Bravecto contains:
BRAVECTO
CHEWABLE TABLETS
FLURALANER (MG)
for very small dogs (2 – 4.5 kg)
112.5
for small dogs (>4.5 – 10 kg)
250
for medium-sized dogs (>10 – 20 kg)
500
for large dogs (>20 – 40 kg)
1,000
for very large dogs (>40 – 56 kg)
1,400
Light to dark brown tablet with a smooth or slightly rough surface and
circular shape. Some marbling,
speckles or both may be visible.
4.
INDICATIONS
For the treatment of tick and flea infestations on dogs.
This veterinary medicinal product is a systemic insecticide and
acaricide that provides
-
immediate and persistent flea (
_Ctenocephalides felis_
) killing activity for 12 weeks,
42
-
immediate and persistent tick killing activity for 12 weeks for
_ Ixodes ricinus, Dermacentor _
_reticulatus _
and
_ D. variabilis;_
-
immediate and persistent tick killing activ
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto 112.5 mg chewable tablets for very small dogs (2 – 4.5 kg)
Bravecto 250 mg chewable tablets for small dogs (>4.5 – 10 kg)
Bravecto 500 mg chewable tablets for medium-sized dogs (>10 – 20 kg)
Bravecto 1,000 mg chewable tablets for large dogs (>20 – 40 kg)
Bravecto 1,400 mg chewable tablets for very large dogs (>40 – 56 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each chewable tablet contains:
BRAVECTO CHEWABLE TABLETS
FLURALANER (MG)
for very small dogs (2 – 4.5 kg)
112.5
for small dogs (>4.5 – 10 kg)
250
for medium-sized dogs (>10 – 20 kg)
500
for large dogs (>20 – 40 kg)
1,000
for very large dogs (>40 – 56 kg)
1,400
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Light to dark brown tablet with a smooth or slightly rough surface and
circular shape. Some marbling,
speckles or both may be visible.
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_
) killing activity for 12 weeks,
-
immediate and persistent tick killing activity for 12 weeks for
_ Ixodes ricinus, Dermacentor _
_reticulatus _
and
_ D. variabilis,_
-
immediate and persistent tick killing activity for 8 weeks for
_Rhipicephalus sanguineus_
.
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.
For reduction of the risk of infection with
_Babesia canis canis_
via transmission by
_Dermacentor _
_reticulatus_
fo
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