NUFLOR- florfenicol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

Florfenicol

Composition:

Florfenicol 300 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

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: