BRAVECTO- fluralaner solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

FLURALANER (UNII: WSH8393RM5) (FLURALANER - UNII:WSH8393RM5)

Διαθέσιμο από:

Merck Sharp & Dohme Corp.

INN (Διεθνής Όνομα):

Fluralaner

Σύνθεση:

Fluralaner 112.5 mg

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

Bravecto kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis ) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. There are no known contraindications for the use of the product.

Περίληψη προϊόντος:

Bravecto is available in five strengths for use in dogs (112.5, 250, 500, 1000, and 1400 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton.

Καθεστώς αδειοδότησης:

New Animal Drug Application

Αρχείο Π.Χ.Π.

BRAVECTO- FLURALANER SOLUTION
MERCK SHARP & DOHME CORP.
----------
BRAVECTO
(FLURALANER TOPICAL SOLUTION) FOR DOGS
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Each tube is formulated to provide a minimum dose of 11.4 mg/lb (25
mg/kg) body
weight. Each milliliter contains 280 mg of fluralaner.
The chemical name of fluralaner is
(±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5-
dihydroisoxazol-3-yl]-2-methyl-_N_-[2-oxo-2-(2,2,2-
trifluoroethylamino) ethyl]benzamide.
Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide,
acetone
INDICATIONS:
Bravecto kills adult fleas and is indicated for the treatment and
prevention of flea
infestations (_Ctenocephalides felis_) and the treatment and control
of tick infestations
[_Ixodes scapularis_ (black-legged tick), _Dermacentor variabilis_
(American dog tick), and
_Rhipicephalus sanguineus_ (brown dog tick)] for 12 weeks in dogs and
puppies 6 months
of age and older, and weighing 4.4 pounds or greater.
Bravecto is also indicated for the treatment and control of _Amblyomma
americanum_
(lone star tick) infestations for 8 weeks in dogs and puppies 6 months
of age and older,
and weighing 4.4 pounds or greater.
DOSAGE AND ADMINISTRATION:
Bravecto should be administered topically as a single dose every 12
weeks according to
the DOSAGE SCHEDULE below to provide a minimum dose of 11.4 mg/lb (25
mg/kg)
body weight.
Bravecto may be administered every 8 weeks in case of potential
exposure to
_Amblyomma americanum_ ticks (see EFFECTIVENESS).
DOSAGE SCHEDULE
BODY WEIGHT RANGES
(LB)
FLURALANER CONTENT
(MG)/TUBE
TUBES ADMINISTERED
4.4 – 9.9
112.5
One
>9.9 – 22.0
250
One
>22.0 – 44.0
500
One
>44.0 – 88.0
1000
One
®
*
*
>88.0 – 123.0
1400
One
STEP 1: Immediately before use, open the pouch and remove the tube.
Hold the tube at
the crimped end with the cap in an upright position (tip up). The cap
should be rotated
clockwise or counter clockwise one full turn. The cap is designed to
stay on the t