BRAVECTO 1400 MG SPOT-ON SOLUTION VETERINARY DOGS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FLURALANER

متاح من:

INTERVET ( ISRAEL) LTD

الشكل الصيدلاني:

SPOT-ON SOLUTION

تركيب:

FLURALANER 280 MG / 1 ML

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

INTERVET INTERNATIONAL B.V. (MSD ANIMAL HEALTH), NETHERLANDS

الخصائص العلاجية:

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.

تاريخ الترخيص:

2023-06-30

نشرة المعلومات

PATIENT LEAFLET FOR VETERINARY MEDICINAL PRODUCT
This product is marketed with a veterinarian’s prescription only
For use in animals only
1. NAME OF THE MEDICINAL PRODUCT:
BRAVECTO 112.5 MG SPOT-ON SOLUTION VETERINARY DOGS
BRAVECTO 250 MG SPOT-ON SOLUTION VETERINARY DOGS
BRAVECTO 500 MG SPOT-ON SOLUTION VETERINARY DOGS
BRAVECTO 1000 MG SPOT-ON SOLUTION VETERINARY DOGS
BRAVECTO 1400 MG SPOT-ON SOLUTION VETERINARY DOGS
Solution for topical use.
2. COMPOSITION:
:
substance
Active
Each ml contains 280 mg Fluralaner.
Each pipette contains:
FLURALANER
(MG)
PIPETTE CONTENT
(ML)
PRODUCT
112.5
0.4
BRAVECTO 112.5 MG SPOT-ON SOLUTION VETERINARY
DOGS -
For very small dogs (2-4.5 kg)
250
0.89
BRAVECTO 250 MG SPOT-ON SOLUTION VETERINARY
DOGS -
For small dogs (>4.5-10 kg)
500
1.79
BRAVECTO 500 MG SPOT-ON SOLUTION VETERINARY
DOGS -
For medium-sized dogs (>10-20 kg)
1,000
3.57
BRAVECTO 1000 MG SPOT-ON SOLUTION VETERINARY
DOGS - For large dogs (>20-40 kg)
1,400
5.0
BRAVECTO 1400 MG SPOT-ON SOLUTION VETERINARY
DOGS -
For very large dogs (>40-56 kg)
For the full list of excipients, see section 13 – "Additional
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_ and
_Ctenocephalides _
_canis_) killing activity for 12 weeks,
-
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.
Therapeutic group: Ectoparasiticides for systemic use.
4. CONTRAINDICATIONS:
Do not use in case of hypersensit

خصائص المنتج

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bravecto 112.5 mg spot-on solution Veterinary Dogs
Bravecto 250 mg spot-on solution Veterinary Dogs
Bravecto 500 mg spot-on solution Veterinary Dogs
Bravecto 1000 mg spot-on solution Veterinary Dogs
Bravecto 1400 mg spot-on solution Veterinary Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains 280 mg fluralaner.
Each pipette delivers:
PIPETTE CONTENT
FLURALANER
(ML)
(MG)
for very small dogs 2 – 4.5 kg
0.4
112.5
for small dogs >4.5 – 10 kg
0.89
250
for medium-sized dogs >10 – 20 kg
1.79
500
for large dogs >20 – 40 kg
3.57
1000
for very large dogs >40 – 56 kg
5.0
1400
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.
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 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.
4.5
SPECIAL PRECAUTIONS FOR USE
Spe