BRAVECTO- fluralaner solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merck Sharp & Dohme Corp.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Bravecto kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick) and Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater. Bravecto is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater. There are no known contraindications for the use of the product.

Product summary:

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

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BRAVECTO- FLURALANER SOLUTION
MERCK SHARP & DOHME CORP.
----------
BRAVECTO
(FLURALANER TOPICAL SOLUTION)
FOR CATS
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 18.2 mg/lb (40
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 _Ixodes scapularis_
(black-legged tick) and _Haemaphysalis longicornis_ (Asian longhorned
tick) infestations for
12 weeks in cats and kittens 6 months of age and older, and weighing
2.6 pounds or
greater.
Bravecto is also indicated for the treatment and control of
_Dermacentor variabilis_
(American dog tick) infestations for 8 weeks in cats and kittens 6
months of age and
older, and weighing 2.6 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 18.2 mg/lb (40
mg/kg)
body weight.
Bravecto may be administered every 8 weeks in case of potential
exposure to
_Dermacentor variabilis_ ticks (see EFFECTIVENESS).
DOSAGE SCHEDULE:
BODY WEIGHT
RANGES (LB)
FLURALANER
CONTENT
(MG/TUBE)
TUBES
ADMINISTERED
2.6 – 6.2
112.5
One
>6.2 – 13.8
250
One
®
*
*
>13.8 – 27.5
500
One
A veterinarian or veterinary technician should demonstrate or instruct
the pet owner
regarding the appropriate technique for applying Bravecto topically to
cats prior to first
use.
STEP 1: Immediately before use, open the pouch and remove the tube.
Put on gloves.
Hold the tube at the crimped end with the cap in an upright position
(tip up)