NuflorŪ Injectable Solution

FDA Approved Animal Drug Products
Online Database System
Drug Product Abstract

Please note that the US Code of Federal Regulations (21 CFR version April 1, 2000) is the official source of regulatory information concerning approved animal drug products.


141-063 (Rx)

Tradename(s) NuflorŪ Injectable Solution
Sponsor Schering-Plough Animal Health Corp.
Ingredient(s) Florfenicol
Species Cattle, any use class, not breeding animals; Cattle, calves, excluding veal calves
Route(s) Intramuscular; Subcutaneous
DoseForm(s) Liquid
Withdrawal Time Cattle: 28 days before slaughter if given IM; 38 days if given SQ


CFR Indications
 
 
 
 
 
522.955 Florfenicol solution.

Specifications:
Each milliliter of sterile solution contains 300 milligrams of florfenicol.

Conditions of use:

Cattle

Amount:
For intramuscular injection use 20 milligrams per kilogram of body weight (3 milliliters per 100 pounds). A second dose should be given 48 hours later. Alternatively, a single subcutaneous injection of 40 milligrams per kilogram of body weight (6 milliliters per 100 pounds) may be used.

Indications:
For treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Limitations:
For intramuscular use only. Do not inject more than 10 milliliters at each site. Injection should be given in the neck only. Do not slaughter within 28 days of last intramuscular treatment. Do not use in female dairy cattle 20 months of age or older. Use may cause milk residues. Not for use in veal calves, calves under 1 month of age, or calves being fed an all milk diet. Use may cause violative tissue residues to remain beyond the withdrawal time. Not for use in cattle of breeding age. The effect of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Amount:
40 milligrams per kilogram of body weight (6 milliliters per 100 pounds) as a single subcutaneous injection.

Indications:
For control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD)
associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus.

Limitations:
For subcutaneous use only. Do not inject more than 10 milliliters at each site. Injection should be given in the neck only. Do not slaughter within 38 days of subcutaneous treatment. . Do not use in female dairy cattle 20 months of age or older. Use may cause milk residues. Not for use in veal calves, calves under 1 month of age, or calves being fed an all milk diet. Use may cause violative tissue residues to remain beyond the withdrawal time. Not for use in cattle of breeding age. The effect of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
 
 
 
 
 
 
 

To see the complete 21 CFR Part 522 955

CFR Tolerance
For Florfenicol:
 
 
 
 
Florfenicol.

The ADI for total residues of florfenicol is 10 micrograms per kilogram of body weight per day.

Tolerances of 3.7 parts per million (ppm) for florfenicol amine (marker residue) in liver (target tissue) and 0.3ppm in muscle are established in cattle.
 
 
 
 
 
Agricultural Research Service

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