Bravecto Plus

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

fluralaner, moxidectin

Saatavilla:

Intervet International B.V.

ATC-koodi:

QP54AB52

INN (Kansainvälinen yleisnimi):

fluralaner, moxidectin

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

Antiparasitic products, insecticides and repellents, Endectocides, Milbemycins

Käyttöaiheet:

For cats with, or at risk from, mixed parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm. The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time.For the treatment of tick and flea infestations in cats providing immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) 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 flea allergy dermatitis (FAD).For the treatment of infestations with ear mites (Otodectes cynotis).For the treatment of infections with intestinal roundworm (4th stage larvae, immature adults and adults of Toxocara cati) and hookworm (4th stage larvae, immature adults and adults of Ancylostoma tubaeforme).When administered repeatedly at a 12-week interval, the product continuously prevents heartworm disease caused by Dirofilaria immitis

Tuoteyhteenveto:

Revision: 8

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-05-08

Pakkausseloste

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET:
BRAVECTO PLUS 112.5 MG / 5.6 MG SPOT-ON SOLUTION FOR SMALL CATS (1.2
– 2.8 KG)
BRAVECTO PLUS 250 MG / 12.5 MG SPOT-ON SOLUTION FOR MEDIUM-SIZED CATS
(>2.8 – 6.25 KG)
BRAVECTO PLUS 500 MG / 25 MG SPOT-ON SOLUTION FOR LARGE CATS (>6.25
– 12.5 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 Productions
Rue de Lyons
27460 Igoville
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2
– 2.8 kg)
Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats
(>2.8 – 6.25 kg)
Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25
– 12.5 kg)
Fluralaner / moxidectin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin.
Each pipette delivers:
BRAVECTO PLUS SPOT-ON SOLUTION
PIPETTE CONTENT (ML)
FLURALANER
(MG)
MOXIDECTIN
(MG)
for small cats 1.2 – 2.8kg
0.4
112.5
5.6
for medium-sized cats >2.8 – 6.25 kg
0.89
250
12.5
for large cats >6.25 – 12.5 kg
1.79
500
25
EXCIPIENT(S):
Butylhydroxytoluene 1.07 mg/ml
Clear colourless to yellow solution.
4.
INDICATION(S)
For cats with, or at risk from, mixed parasitic infestations by ticks
or fleas and ear mites,
gastrointestinal nematodes or heartworm. The veterinary medicinal
product is exclusively indicated
when use against ticks or fleas and one or more of the other target
parasites is indicated at the same
time.
For the treatment of tick and flea infestations in cats providing
immediate and persistent flea
(
_Ctenocephalides felis_
) and tick (
_Ixodes ricinus) _
killing activity for 12 weeks.
21
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
subst

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto Plus 112.5 mg / 5.6 mg spot-on solution for small cats (1.2
– 2.8 kg)
Bravecto Plus 250 mg / 12.5 mg spot-on solution for medium-sized cats
(>2.8 – 6.25 kg)
Bravecto Plus 500 mg / 25 mg spot-on solution for large cats (>6.25
– 12.5 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin.
Each pipette delivers:
BRAVECTO PLUS SPOT-ON SOLUTION
PIPETTE CONTENT (ML)
FLURALANER
(MG)
MOXIDECTIN
(MG)
for small cats 1.2 – 2.8 kg
0.4
112.5
5.6
for medium-sized cats >2.8 – 6.25 kg
0.89
250
12.5
for large cats >6.25 – 12.5 kg
1.79
500
25
EXCIPIENT(S):
Butylhydroxytoluene 1.07 mg/ml
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
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
cats
with,
or
at
risk
from,
mixed
parasitic
infestations
by
ticks
or
fleas
and
ear
mites,
gastrointestinal nematodes or heartworm. The veterinary medicinal
product is exclusively indicated
when use against ticks or fleas and one or more of the other target
parasites is indicated at the same
time.
For the treatment of tick and flea infestations in cats providing
immediate and persistent flea
(
_Ctenocephalides felis_
) and tick (
_Ixodes ricinus) _
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 flea
allergy dermatitis (FAD).
For the treatment of infestations with ear mites (
_Otodectes cynotis_
).
For the treatment of infections with intestinal roundworm (4
th
stage larvae, immature adults and adults
of
_Toxocara cati_
) and hookworm (4
th
stage larvae, immature adults and adults of
_Ancylostoma _
_tubaeforme_
).
3
When administered repeatedly at a 12-week interval, the product
co