Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
FLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H)
Merck Sharp & Dohme Corp.
Florfenicol
Florfenicol 300 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION
INDICATIONS NUFLOR Injectable Solution is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni . CONTRAINDICATIONS Do not use in animals that have shown hypersensitivity to florfenicol.
HOW SUPPLIED NUFLOR Injectable Solution is packaged in 100 mL (NDC 0061-1116-04), 250 mL (NDC 0061-1116-05), and 500 mL (NDC 0061-1116-06) glass sterile multiple-dose vials.
New Animal Drug Application
NUFLOR- FLORFENICOL INJECTION, SOLUTION MERCK SHARP & DOHME CORP. ---------- NUFLOR (FLORFENICOL) INJECTABLE SOLUTION 300 MG/ML PRODUCT INFORMATION APPROVED BY FDA UNDER NADA # 141-063 FOR INTRAMUSCULAR AND SUBCUTANEOUS USE IN BEEF AND NON-LACTATING DAIRY CATTLE ONLY. NOT FOR USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER OR IN CALVES TO BE PROCESSED FOR VEAL. CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION NUFLOR Injectable Solution is a solution of the synthetic antibiotic florfenicol. Each milliliter of sterile NUFLOR Injectable Solution contains 300 mg of florfenicol, 250 mg _N_-methyl-2-pyrrolidone (NMP), 150 mg propylene glycol, and polyeth- ylene glycol qs. The chemical name for florfenicol is _2_,_2-Dichloro-N-[1-(fluoromethyl)-2-_ _hydroxy-2-[4-(methylsulfonyl)phenyl]ethyl] acetamide._ INDICATIONS NUFLOR Injectable Solution is indicated for treatment of bovine respiratory disease (BRD) associated with _Mannheimia haemolytica, Pasteurella_ _multocida,_ and _Histophilus somni,_ and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with _Fusobacterium necrophorum_ and _Bacteroides melaninogenicus_. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with _Mannheimia haemolytica, Pasteurella multocida,_ and _Histophilus somni_. DOSAGE AND ADMINISTRATION For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot): NUFLOR Injectable Solution should be administered by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be adminis-tered 48 hours later. Alternatively, NUFLOR Injectable Solution can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck. NOTE: Citiți documentul complet