Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457), EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9)
Bayer HealthCare LLC Animal Health Division
PRAZIQUANTEL
PRAZIQUANTEL 30 mg in 0.35 mL
TOPICAL
PRESCRIPTION
PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.
Code Number Applications per Package 82232699 8 – 0.35 mL tubes (2 blisters of 4 tubes) 20 - 0.7 mL tubes (5 blisters of 4 tubes) 8 – 1.12 mL tubes (2 blisters of 4 tubes) 82482521 20 - 0.35 mL tubes (5 blisters of 4 tubes) 03615026 40 - 0.35 mL tubes (10 blisters of 4 tubes) 82482572 20 - 0.7 mL tubes (5 blisters of 4 tubes) 03615034 40 - 0.7 mL tubes (10 blisters of 4 tubes) 82482580 20 - 1.12 mL tubes (5 blisters of 4 tubes) 82482602 40 - 1.12 mL tubes (10 blisters of 4 tubes) Profender is protected by the following U.S. Patents: 5514773 and other patents pending. Made in Germany NADA 141-275, Approved by FDA © 2014 Bayer HealthCare LLC Bayer, the Bayer Cross and Profender are registered trademarks of Bayer. February, 2014 Bayer HealthCare LLC Animal Health Division P.O. Box 390 Shawnee Mission, Kansas 66201 U.S.A.
New Animal Drug Application
PROFENDER- EMODEPSIDE/PRAZIQUANTEL SOLUTION PROFENDER- EMODEPSIDE/PRAZIQUANTEL BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION ---------- TOPICAL SOLUTION PROFENDER (EMODEPS IDE/PRAZIQUANTEL) CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the order of a licensed veterinarian. Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections in cats and kittens that are at least 8 weeks of age and weigh at least 2.2 lbs (1 kg). DESCRIPTION: PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a clear yellow ready-to- use solution packaged in single unit dosing applicator tubes for topical (dermal) treatment of cats 8 weeks of age and older and weighing at least 2.2 lbs (1 kg). The formulation and dosage schedule is designed to provide a minimum of 1.36 mg/lb (3 mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based on body weight. Emodepside, a semi-synthetic molecule, is a cyclic depsipeptide. The chemical name is Cyclo [D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]- D-2-hydroxypropanoyl-N-methyl-L-leucyl-D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4- morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl]. Praziquantel is an isoquinoline cestocide. The chemical name is 2-Cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazine-2,1-a- isoquinoline-4-one. INDICATIONS: PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by _Ancylostoma tubaeforme_ (adults, immature adults, and fourth stage larvae), roundworm infections caused by _Toxocara cati_ (adults and fourth stage larvae), and tapeworm infections caused by _Dipylidium caninum _(adults) and _Taenia taeniaeformis _(adults) in cats. DOSAGE AND ADMINISTRATION: The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45 mg/lb (12 mg/kg) praziquantel as a single topical dose. A single treatment is effective and a second treatment should not be necessary. If re-infection occurs, the product can be re-applied after 30 day read_full_document