Label: FUMAGILIN-B- fumagillin dicyclohexylamine powder, for solution

  • NDC Code(s): 86196-001-24, 86196-001-45, 86196-001-96
  • Packager: VITA BEE HEALTH CANADA LTD
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 14, 2024

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

  • ACTIVE INGREDIENTS:

     21 mg fumagillin base (as fumagillin dicyclohexylamine) per g of powder.

  • INDICATIONS:

    As an aid in the prevention of Nosema in honey bees.

  • DIRECTIONS FOR USE:

    This jar contains the equivalent of 0.5 g Fumagillin base which is sufficient to prepare 20 Litres of medicated syrup for feeding of 5-6 package colonies or for fall feeding of 3 wintering colonies.

    This jar contains the equivalent of 2.0 g Fumagillin base which is sufficient to prepare 80 Litres of medicated syrup for feeding of 22 package colonies or for fall feeding of 12 wintering colonies.

    This jar contains the equivalent of 9.5 g Fumagillin base which is sufficient to prepare 380 Litres of medicated syrup for feeding of 100-110 package colonies or for fall feeding of 50 wintering colonies.

    Consult package insert for detailed directions for the preparation of the medicated syrup and dosage instructions.

    Mixing and Feeding Instructions in U.S. Measurements
    Preparation of Medicated Syrup:

     Water + Sugar = Syrup+ Fumagilin-B 
     44 gallons+ 727 lbs. = 100 gallons + 16 ounces (454 g bottle) 
     9½ gallons + 152 lbs.= 21 gallons + 3.4 ounces (96 g bottle) 
     2¾ gallons + 37 lbs. = 5.2 gallons+ 0.85 ounces (24 g bottle) 
     ½ Gallon + 8 lbs. = 1 gallon0.18 ounces
    (5 g = ½ rounded tablespoon) 

    Fall Feeding Medicated Syrup

    2 gallons for each 2-chamber colony (approx. 30,000 bees)
    1 gallon for each 1-chamber colony (approx. 18,000 bees)
    3/4 gallon for each 5-frame colony (approx. 12,000 bees)

    Feed additional unmedicated syrup to desired colony weight for wintering.

    Spring Feeding Medicated Syrup

    1 gallon for each 2-chamber colony (approx. 20,000 bees)
    ½ gallon for each 1-chamber colony (approx. 12,000 bees)
    ½ gallon for each 5-frame colony (approx. 8,000 bees)
    1 gallon for each package colony.

    Feed additional unmedicated syrup to provide nourishment until nectar is available.

    Additional Measurements (approximate)
    ½ teaspoon = 1.5 g Fumagilin-B (31.5 mg activity)
    1 teaspoon = 3.0 g Fumagilin-B (63 mg activity)
    ½ tablespoon = 5.0 g Fumagilin-B (100 mg activity)
    1 tablespoon = 9.5 g Fumagilin-B (200 mg activity)
    2/3 cup = 50 g Fumagilin-B (1.05 g activity)

  • STORAGE:

    Store below 25˚C, protected from sunlight. Keep from freezing. Once mixed, do not expose medicated syrup to sunlight.

  • SPL UNCLASSIFIED SECTION

    FUMAGILLIN DICYCLOHEXYLAMINE SOLUBLE POWDER

    FOR VETERINARY USE ONLY

    WARNINGS: See package insert for complete warnings.

    Distributed by:
    Can-Vet Animal Health Supplies Ltd.
    4-61 Malcolm Road, Guelph, ON N1K 1A7
    1-800-265-9754

    Vita Bee Health Canada Ltd.
    150 Caroline Street
    Suite 402 Waterloo
    ON N2L 0A5

  • Packaging

    VITA BEE

  • INGREDIENTS AND APPEARANCE
    FUMAGILIN-B 
    fumagillin dicyclohexylamine powder, for solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86196-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BICYCLOHEXYLAMMONIUM FUMAGILLIN (UNII: 0W72P6E6EY) (FUMAGILLIN - UNII:7OW73204U1) BICYCLOHEXYLAMMONIUM FUMAGILLIN21 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86196-001-2424 g in 1 JAR
    2NDC:86196-001-9696 g in 1 JAR
    3NDC:86196-001-45454 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/08/2024
    Labeler - VITA BEE HEALTH CANADA LTD (243313029)