Label: NUFLOR GOLD- florfenicol injection 

  • Label RSS
  • NDC Code(s): 0061-5327-01, 0061-5327-02, 0061-5327-03
  • Packager: Schering Corporation
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 09/09

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Injectable Solution, An Antimicrobial
    300 mg/mL

    For 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

    PRODUCT
    INFORMATION

    Close
  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    Close
  • DESCRIPTION

    NUFLOR GOLD™ is an injectable solution of the synthetic antibiotic florfenicol. Each milliliter of sterile NUFLOR GOLD™ contains 300 mg of florfenicol, 300 mg of 2-pyrrolidone, and triacetin qs.

    Close
  • INDICATION

    NUFLOR GOLD™ is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

    Close
  • DOSAGE AND ADMINISTRATION

    NUFLOR GOLD™ should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight (6 mL/100 lb). Do not administer more than 15 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated.

    NUFLOR GOLD™ Dosage Guide
    ANIMAL WEIGHT
    (lb)
    DOSAGE
    (mL)
    100 6.0 Recommended Injection Location:

    Figure
    200 12.0
    300 18.0
    400 24.0
    500 30.0
    600 36.0
    700 42.0
    800 48.0
    900 54.0
    1000 60.0
    Close
  • CONTRAINDICATIONS

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

    Close
  • WARNINGS

    NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains materials that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

    For customer service, to report suspected adverse reactions, or to obtain a copy of the MSDS, call 1-800-211-3573.

    Close
  • PRECAUTIONS

    Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

    Subcutaneous injection in cattle can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

    Close
  • RESIDUE WARNINGS

    Animals intended for human consumption must not be slaughtered within 44 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

    Close
  • ADVERSE REACTIONS

    Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle.

    Close
  • CLINICAL PHARMACOLOGY

    The pharmacokinetic disposition of NUFLOR GOLD™ was evaluated in feeder calves following a single subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight. Administration of NUFLOR GOLD™ resulted in florfenicol plasma concentrations of 2 µg (mcg)/mL within two hours of injection.

    Table 1. Pharmacokinetic Parameter Values for Florfenicol Following a Single Subcutaneous Injection of NUFLOR GOLD™ at a Dose Rate of 40 mg Florfenicol/kg Body Weight to Feeder Calves (n=24).
    Cmax
    (µg/mL)
    Tmax
    (hr)
    AUClast
    (µg*hr/mL)

    (hr)
    Cmax: Maximum observed plasma concentration
    Tmax: Time at which Cmax was observed
    AUClast: Area under the plasma-concentration-time curve from time zero to the last quantifiable concentration that is equal to or greater than the limit of quantification of the validated analytical method
    T½: Terminal elimination half-life
    % CV: Percent coefficient of variance
    *
    T ½ value could not be accurately estimated for one calf
    T max is presented as the median value or range of observed values (minimum to maximum)
    n 24 24 24 23*
    Mean 5.93 5 150 37.7
    % CV 38.3 2-12 20.9 27.3
    Figure 1. Mean Florfenicol Plasma Concentration versus Time Following a Single Subcutaneous Injection of NUFLOR GOLD™ at a Dose Rate of 40 mg Florfenico/kg Body Weight in Feeder Calves (Mean ± Standard Error of the Mean)
    Figure 1

    MICROBIOLOGY

    Florfenicol is a synthetic, broad-spectrum antibiotic active against many Gram-negative and Gram-positive bacteria isolated from domestic animals. It acts by binding to the 50S ribosomal subunit and inhibiting bacterial protein synthesis. Florfenicol is generally considered a bacteriostatic drug, but it exhibits bactericidal activity against certain bacterial species. In vitro studies demonstrate that florfenicol is active against the BRD pathogens M. haemolytica, P. multocida, H. somni, and M. bovis and that florfenicol exhibits bactericidal activity against strains of M. haemolytica and H. somni.

    The minimum inhibitory concentrations (MICs) of florfenicol were determined for BRD isolates obtained from calves enrolled in BRD field studies in the U.S. in 2006 using methods recommended by the Clinical and Laboratory Standards Institute (M31-A2). Isolates were obtained from pre-treatment nasal swabs from all calves enrolled at all four sites, post-treatment nasal swabs from treatment failures in the NUFLOR GOLD Injectable Solution and saline control treatment groups at three sites, and lung tissue from one calf that died in the saline control treatment group. The results are shown below in Table 2.

    Table 2. Florfenicol MIC values* of indicated pathogens isolated from cattle with naturally-occurring BRD
    Indicated pathogens Year of isolation No. of isolates MIC50
    (µg/mL)
    MIC90
    (µg/mL)
    MIC range
    (µg/mL)
    *
    The correlation between in vitro susceptibility data and clinical effectiveness is unknown.
    The lowest MIC to encompass 50% and 90% of the most susceptible isolates, respectively.
    Mannheimia haemolytica 2006 158 1.0 1.0 0.5 to 32
    Pasteurella multocida 2006 103 0.5 0.5 ≤ 0.125 to 16
    Histophilus somni 2006 85 ≤ 0.125 ≤ 0.125 ≤ 0.125 to 0.25
    Close
  • ANIMAL SAFETY

    A target animal safety study was conducted to evaluate the effects of NUFLOR GOLD™ when administered to feeder cattle by subcutaneous injection at 1X, 3X, or 5X the labeled dose for three consecutive days (3X the labeled duration). Decreased feed consumption (inappetence), decreased water consumption, and injection site swelling were observed in the 1X, 3X, and 5X groups.

    A separate injection site study conducted in cattle demonstrated that NUFLOR GOLD™ may induce a transient local reaction in the subcutaneous tissue and underlying muscle tissue.

    Close
  • STORAGE INFORMATION

    Store between 2°-30°C (36°-86°F). Use within 28 days of first use. Refrigeration is not required. The solution is light yellow to straw colored. Color does not affect potency.

    Close
  • HOW SUPPLIED

    NUFLOR GOLD™ is packaged in 100 mL (NDC 0061-5327-01), 250 mL (NDC 0061-5327-02), and 500 mL (NDC 0061-5327-03) glass sterile multiple-dose vials.

    Close
  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Intervet Inc., Roseland, NJ 07068
    © 2009, Intervet Inc.
    All rights reserved.
    B-31331005   7/09

    F-31331005
    NADA 141-265, Approved by FDA.

    Close
  • PRINCIPAL DISPLAY PANEL - 100 mL vial label

    NuflorGOLD
    (florfenicol)

    Injectable Solution, An Antimicrobial
    For 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
    NADA 141-265, Approved by FDA

    Intervet
    Schering-Plough Animal Health

    NDC 0061-5327-01

    100 mL Multiple Dose Vial • 300 mg/mL • Sterile

    Principal Display Panel - 100 mL vial label
    Close
  • PRINCIPAL DISPLAY PANEL - 100 mL vial carton

    NuflorGOLD
    (florfenicol)

    Injectable Solution,
    An Antimicrobial

    Caution: Federal law restricts this drug to use by or
    on the order of a licensed veterinarian

    NADA 141-265, Approved by FDA

    NDC 0061-5327-01

    Intervet
    Schering-Plough Animal Health

    100 mL Multiple Dose Vial • 300 mg/mL • Sterile

    Principal Display Panel - 100 mL vial carton
    Close
  • PRINCIPAL DISPLAY PANEL - 250 mL vial label

    NuflorGOLD
    (florfenicol)

    Injectable Solution, An Antimicrobial
    For 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
    NADA 141-265, Approved by FDA

    Intervet
    Schering-Plough Animal Health

    NDC 0061-5327-02

    250 mL Multiple Dose Vial • 300 mg/mL • Sterile

    Principal Display Panel - 250 mL vial label
    Close
  • PRINCIPAL DISPLAY PANEL - 500 mL vial label

    NuflorGOLD
    (florfenicol)

    Injectable Solution, An Antimicrobial
    For 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
    NADA 141-265, Approved by FDA

    Intervet
    Schering-Plough Animal Health

    NDC 0061-5327-03

    500 mL Multiple Dose Vial • 300 mg/mL • Sterile

    Principal Display Panel - 500 mL vial label
    Close
  • INGREDIENTS AND APPEARANCE
    NUFLOR GOLD 
    florfenicol injection
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:0061-5327
    Route of Administration SUBCUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Florfenicol (Florfenicol) Florfenicol 300 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Triacetin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0061-5327-01 1 in 1 CARTON
    1 100 mL in 1 VIAL, MULTI-DOSE
    2 NDC:0061-5327-02 250 mL in 1 VIAL, MULTI-DOSE
    3 NDC:0061-5327-03 500 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141265 09/18/2009
    Labeler - Schering Corporation (001317601)
    Establishment
    Name Address ID/FEI Business Operations
    Essex Animal Health Friesoythe 330363511 ANALYSIS, MANUFACTURE
    Close