Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SAROLANER (UNII: DM113FTW7F) (SAROLANER - UNII:DM113FTW7F), MOXIDECTIN (UNII: NGU5H31YO9) (MOXIDECTIN - UNII:NGU5H31YO9), PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)
Zoetis Inc.
ORAL
PRESCRIPTION
SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. SIMPARICA TRIO kills adult fleas (Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (blacklegged tick), and Rhipicephalus sanguineus (brown dog tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. SIMPARICA TRIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. There are no known contraindications for the use of SIMPARICA TRIO.
SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) is available in six flavored tablet sizes (see DOSAGE AND ADMINISTRATION ). Each tablet size is available in packages of one, three, or six tablets.
New Animal Drug Application
SIMPARICA TRIO- SAROLANER, MOXIDECTIN, AND PYRANTEL TABLET, CHEWABLE ZOETIS INC. ---------- _SIMPARICA TRIO_ _SIMPARICA TRIO_ _(SAROLANER, MOXIDECTIN, AND PYRANTEL CHEWABLE TABLETS)_ 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 TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) is a flavored, chewable tablet for administration to dogs 8 weeks of age and older. Each tablet is formulated to provide minimum dosages of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 μg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt). 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 TRIO contains the S-enantiomer of sarolaner. Moxidectin is a semi-synthetic methoxime derivative of nemadectin which is a fermentation product of Streptomyces cyaneogriseus subspecies noncyanogenus. Moxidectin is a pentacyclic 16-membered lactone macrolide. The chemical name for moxidectin is (6R,23E,25S)-5-O-Demethyl-28-deoxy-25-[(1E)-1,3-dimethyl-1-buten-1-yl]- 6,28-epoxy-23-(methoxyimino)milbemycin B. Pyrantel belongs to a family classified chemically as tetrahydropyrimidines and the chemical name is (E)‑1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4,4’ methylenebis [3-hydroxy-2-naphthoate] (1:1). It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. INDICATIONS SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by _Dirofilaria immitis_ and for the treatment and control of roundworm (immature adult and adult _Toxocara canis_ and adult _Toxascaris leonina_) and hookworm (L4, immature adult, and adult_ Ancylostoma caninum _and adult _Uncinaria stenocephala_) infections. SIMPARICA TRIO read_full_document