FUMAGILIN-B- fumagillin dicyclohexylamine powder, for solution

FUMAGILIN-B by

Drug Labeling and Warnings

FUMAGILIN-B by is a Animal medication manufactured, distributed, or labeled by VITA BEE HEALTH CANADA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Medicated syrup is best prepared at a concentration of 25 mg Fumagillin base per Litre of syrup, usually as a 2:1 syrup (two parts of sugar to one part of water). Fumagilin-B may be dissolved in water or syrup at room temperature. For best results, heat the required amount of water to 95-122˚F, then remove the heat source and add the Fumagilin-B and the sugar in that order. To prepare this concentration of medicated syrup, use the following chart:

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 gallon	0.18 ounces; (5 g = ½ rounded tablespoon)

Good agitation is essential to assure uniform distribution of the medication.
For the protection of wintering colonies, medicated syrup is best fed in the fall if it is fed only once per year. There may be advantages to feeding medicated syrup in both the fall and the spring.

DOSAGE AND ADMINISTRATION:

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)

For additional information please turn page over
Feed additional unmedicated syrup to provide nourishment until nectar is available. Package bees may have been fed medicated syrup in transit, but such feeding alone is not sufficient to protect against Nosema. Each package colony is best fed Fumagilin-B immediately after installation.
Colonies used for package production should be fed medicated syrup as a principle food source for one month prior to taking to market.
Heavily infested colonies that will no longer take in syrup may be sprayed repeatedly, directly on the bees, frame by frame with a 1:1 sugar syrup (one part sugar to one part water) containing 2 g of Fumagilin-B per Litre of syrup.

WARNINGS:

To avoid violative residues in honey, Fumagilin-B should be fed early in the spring or fall and consumed by the bees before the main honey flow begins. Complete treatments at least 4 weeks prior to the main honey flow. Honey collected in supers before the end of the 4 week withdrawal period should not be harvested for human consumption. Honey from brood nest areas of colonies treated with Fumagilin-B should not be harvested for human consumption.
When handling the product, avoid inhalation, oral exposure and direct contact with skin or eyes. Keep out of reach of children.

STORAGE:

Store below 77˚F, protected from sunlight. Keep from freezing. Once mixed, do not expose medicated syrup to sunlight.

SPL UNCLASSIFIED SECTION

DESCRIPTION: Fumagilin-B is a water-soluble preparation containing the antibiotic fumagillin dicyclohexylamine equivalent to 21 mg fumagillin base per gram of powder. Fumagillin base has a high specific action against Nosema apis, a microscopic single-celled parasite which causes Nosema disease in honey bees. It acts on the multiplying, disease producing parasite in the gut and is not effective against the spores. To eradicate the continuing supply of parasites, Fumagilin-B must be provided over a period of several weeks.

For additional information please turn page over

Manufactured by: Can-Vet Animal Health Supplies Ltd,
4-61 Malcolm Road, Guelph, ON N1K 1A7, Canada

Distributed in the USA by Vita Bee Health Canada Ltd.
1187 Fischer-Hallman Road, Suite 627,
Kitchener, ON N2E 4H9, Canada
Tel: +1 (519) 822-5333

FUMAGILLIN DICYCLOHEXYLAMINE SOLUBLE POWDER

FOR VETERINARY USE ONLY

WARNINGS: See package insert for complete warnings.

Packaging

INGREDIENTS AND APPEARANCE

FUMAGILIN-B 
fumagillin dicyclohexylamine powder, for solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86196-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BICYCLOHEXYLAMMONIUM FUMAGILLIN (UNII: 0W72P6E6EY) (FUMAGILLIN - UNII:7OW73204U1)	BICYCLOHEXYLAMMONIUM FUMAGILLIN	21 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86196-001-24	24 g in 1 JAR
2	NDC: 86196-001-96	96 g in 1 JAR
3	NDC: 86196-001-45	454 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/08/2024

Labeler - VITA BEE HEALTH CANADA LTD (243313029)