BRAVECTO 112.5 MG CHEWABLE TABLETS VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLURALANER

Available from:

INTERVET ( ISRAEL) LTD

Pharmaceutical form:

CHEWABLE TABLETS

Composition:

FLURALANER 112.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

INTERVET GESMBH, AUSTRIA

Therapeutic indications:

Dogs: For the treatment of tick and flea infestations in dogs. This veterinary medicinal product is a systemic insecticide and acaricide that provides:- Immediate and presistent 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 presistent 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 onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus). 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.

Authorization date:

2021-04-30

Patient Information leaflet

VETERINARY PRODUCT USER LEAFLET
The product is dispensed with a veterinarian’s prescription only
For veterinary use only
1. NAME OF THE MEDICINAL PRODUCT:
BRAVECTO 112.5 MG CHEWABLE TABLETS VETERINARY
BRAVECTO 250 MG CHEWABLE TABLETS VETERINARY
BRAVECTO 500 MG CHEWABLE TABLETS VETERINARY
BRAVECTO 1000 MG CHEWABLE TABLETS VETERINARY
BRAVECTO 1400 MG CHEWABLE TABLETS VETERINARY
2. COMPOSITION:
Active substance:
Each chewable tablet contains:
PRODUCT
FLURALANER (MG)
BRAVECTO 112.5 MG CHEWABLE TABLETS
VETERINARY –
for very small dogs (2-4.5 kg)
112.5
BRAVECTO 250 MG CHEWABLE TABLETS VETERINARY
–
for small dogs (>4.5-10 kg)
250
BRAVECTO 500 MG CHEWABLE TABLETS VETERINARY
–
for medium-sized dogs (>10-20 kg)
500
BRAVECTO 1000 MG CHEWABLE TABLETS VETERINARY
–
for large dogs (>20-40 kg)
1,000
BRAVECTO 1400 MG CHEWABLE TABLETS VETERINARY
–
for very large dogs (>40-56 kg)
1,400
See list of excipients in section 13 - “Further Information”.
3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR:
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 killing activity for 12 weeks of ticks of
types _Ixodes ricinus, Dermacentor _
_reticulatus, Dermacentor variabilis_.
-
immediate and persistent killing activity for 8 weeks of tick type
_Rhipicephalus sanguineus_.
Fleas and ticks should attach to the host and commence feeding in
order to be exposed to the active
substance.
The onset of the effect of the product is within 8 hours of attachment
of the fleas (_C. felis_) and within
12 hours of attachment of ticks (_I. ricinus_).
The product can be used as part of a treatment and prevention strategy
for flea allergy dermatitis
(FAD).
For the treatment of demodicosis caused by _Demodex canis_.
2
For the treatment of sarcoptic mange (_Sarcoptes scabiei_ var.
_canis_) infestation.
Therapeutic group: Ectoparasiticides for syste

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto 112.5 mg Chewable Tablets Veterinary
Bravecto 250 mg Chewable Tablets Veterinary
Bravecto 500 mg Chewable Tablets Veterinary
Bravecto 1000 mg Chewable Tablets Veterinary
Bravecto 1400 mg Chewable Tablets Veterinary
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 onset of effect is within 8 hours of attachment for
fleas (
_C. felis_
) and 12 hours of
attachment for ticks (
_I. ricinus_
).
The product can be used as part of a treatment strategy for the
control of flea allergy dermatitis (FAD).
2
For the treatment of demodicosis caused by
_Demodex canis_
.
For the treatment of sarcoptic mange (
_Sarcoptes scabiei_
var.
_canis_
) infestation.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS FOR EAC