NORFENICOL- florfenicol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

florfenicol (UNII: 9J97307Y1H) (florfenicol - UNII:9J97307Y1H)

Available from:

Norbrook Laboratories Limited

INN (International Name):

florfenicol

Composition:

florfenicol 300 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Norfenicol 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. Do not use in animals that have shown hypersensitivity to florfenicol.

Product summary:

Norfenicol Injectable Solution is packaged in 100 mL, 250 mL, and 500 mL sterile multiple-dose vials.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

NORFENICOL- FLORFENICOL INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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NORFENICOL
(FLORFENICOL)
INJECTABLE SOLUTION
300MG/ML
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:
Norfenicol
Injectable Solution is a solution of the synthetic antibiotic
florfenicol. Each
milliliter of sterile Norfenicol Injectable Solution contains 300 mg
of florfenicol, 250 mg 2-
pyrrolidone, and glycerol formal qs.
INDICATIONS:
Norfenicol 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): Norfenicol 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
administered 48 hours later. Alternatively, Norfenicol 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: Intramuscular
injection may result in
local tissue reaction which persists beyond 28 days. This may result
in trim loss of edible
tissue at slaughter. Tissue reaction at injection sites other than the