SIMPARICA CHEWABLES- sarolaner tablet, chewable

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SAROLANER (UNII: DM113FTW7F) (SAROLANER - UNII:DM113FTW7F)

Tilgjengelig fra:

Zoetis Inc.

INN (International Name):

SAROLANER

Sammensetning:

SAROLANER 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION

Indikasjoner:

SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis ), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. There are no known contraindications for the use of SIMPARICA.

Produkt oppsummering:

SIMPARICA (sarolaner) Chewables are available in six flavored tablet sizes: 5, 10, 20, 40, 80, and 120 mg. Each tablet size is available in color-coded packages of one, three, or six tablets.

Autorisasjon status:

New Animal Drug Application

Preparatomtale

SIMPARICA CHEWABLES- SAROLANER TABLET, CHEWABLE
ZOETIS INC.
----------
SIMPARICA
Simparica
(sarolaner) Chewables
FOR ORAL USE IN DOGS ONLY
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
SIMPARICA is a flavored, chewable tablet for administration to dogs
over 6 months of
age according to their weight. Each tablet is formulated to provide a
minimum sarolaner
dosage of 0.91 mg/lb (2 mg/kg ) body weight.
Sarolaner is a member of the isoxazoline class of parasiticides and
the chemical name is
1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-
3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone.
SIMPARICA
contains the S-enantiomer of sarolaner.
INDICATIONS
SIMPARICA kills adult fleas, and is indicated for the treatment and
prevention of flea
infestations (_Ctenocephalides felis_), and the treatment and control
of tick infestations
[_Amblyomma americanum _(lone star tick), _Amblyomma maculatum _(Gulf
Coast tick),
_Dermacentor variabilis _(American dog tick), _Ixodes scapularis
_(black-legged tick), and
_Rhipicephalus sanguineus _(brown dog tick)] for one month in dogs 6
months of age or
older and weighing 2.8 pounds or greater. SIMPARICA is indicated for
the prevention of
_Borrelia burgdorferi_ infections as a direct result of killing
_lxodes scapularis_ vector ticks.
DOSAGE AND ADMINISTRATION
SIMPARICA is given orally once a month at the recommended minimum
dosage of 0.91
mg/lb (2 mg/kg).
Dosage Schedule:
BODY WEIGHT
SAROLANER PER
TABLET (MG)
NUMBER OF
TABLETS
ADMINISTERED
2.8 to 5.5 lbs
5
One
®
®
5.6 to 11.0 lbs
10
One
11.1 to 22.0 lbs
20
One
22.1 to 44.0 lbs
40
One
44.1 to 88.0 lbs
80
One
88.1 to 132.0 lbs 120
One
>132.1 lbs
Administer the appropriate
combination of tablets
SIMPARICA can be offered by hand, in the food, or administered like
other tablet
medications.
Care should be taken that the dog consumes the complete dose, and
treated animals
should be observed for a few minutes to ensu