BILOVET- tylosin tartrate powder, for solution

BiloVet by

Drug Labeling and Warnings

BiloVet by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

FOR ORAL USE IN CHICKENS, TURKEYS, SWINE, AND HONEY BEES

A Macrolide Antibiotic

INDICATIONS:

Chickens: As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of CRD associated with Mycoplasma gallisepticum sensitive to tylosin at the time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.

Turkeys: For the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.

Swine: For the treatment and control of swine dysentery (SD) associated with Brachyspira hyodysenteriae. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A medicated article in feed. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A medicated article in feed.

Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).

WARNINGS

WARNINGS

User Safety Warnings: Not for Use in Humans. Keep out of Reach of Children. Avoid contact with human skin. Exposure to tylosin may cause a rash.

GENERAL PRECAUTIONS

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Restricted Drug (California) - Use only as Directed

TAKE TIME OBSERVE LABEL DIRECTIONS

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

Dosages:

Chickens: CRD indications: 2,000 mg/gallon (528 ppm) in drinking waler.

Turkeys: 2,000 mg/gallon (528 ppm) in drinking waler.

Swine: 250 mg/gallon (66 ppm) in drinking water.

Honey Bees: 200 mg/colony in confectioners/powdered sugar.

Mixing Directions for Medicated Drinking Water:

Always add the water to the powder.

Do not pour the powder into the water. Prepare a fresh Bilovet™ Soluble Powder solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves. If using a water medicating pump see table below, otherwise mix as follows: To assure thorough dissolution, first place the contents of one packet in a mixing container and add one gallon of water (3785 ml) to the powder to make a concentrated solution. To make medicated drinking water containing 250 mg/gallon (66 ppm), mix this concentrated solution with water to make 400 gallons (1514 liters) of medicated drinking water. To make medicated drinking water containing 2,000 mg/gallon (528 ppm), mix this concentrated solution with water to make 50 gallons (189 liters) of medicated drinking water.

Mixing Directions for Water Medicating Pump (1 :128 inclusion)*:  

	Desired Concentration in Drinking Water	Packets of Bilovet™	Volume of water to make Stock Solution
	250 mg/gallon (66 ppm)	1	3 gallons + 13 ounces
	2,000 mg/gallon (528 ppm)	10	3 gallons + 115 ounces

*This table applies only if the water medicating pump is set to deliver 1 ounce of stock solution per gallon of drinking water.

Mixing Directions for use in Honey Bees: Mix 200 mg tylosin in 20 g confectioners/powdered sugar. Use immediately.

DIRECTIONS FOR USE

Chickens: CRD indications: Administer medicated drinking water for three days; however, medicated water may be administered for one to five days depending upon severity of infection. Treated chickens must consume enough medicated water to provide 50 mg per pound of body weight per day. Only medicated water should be available to the birds.

Turkeys: Administer medicated drinking water for three days; however, medicated water may be administered for two to five days depending upon severity of infection. Treated turkeys must consume enough medicated water to provide 60 mg per pound of body weight per day. Only medicated water should be available to the birds.

Swine: SD indication: Administer medicated drinking water for 3 to 10 days, depending upon severity of infection. Alternatively, administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed manufactured from tylosin phosphate Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Bilovet™ Soluble Powder. PPE indication: Administer medicated drinking water for 3 to 10 days, followed by 40 to 100 g of tylosin per ton of complete feed (Type C medicated feed manufactured from tylosin phosphate Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Bilovet™ Soluble Powder.

Honey Bee Colonies: Administer three treatments of medicated confectioners sugar once weekly for 3 weeks. The 200 mg dose is applied (dusted) over the top bars of the brood chamber.

USER SAFETY WARNINGS

WARNINGS

User Safety Warnings: Not for Use in Humans.  Keep out of Reach of Children. Avoid contact with human skin. Exposure to tylosin may cause a rash.

RESIDUE WARNING

Residue Warnings: Chickens must not be slaughtered for food within 24 hours after treatment. Do not use in layers producing eggs for human consumption. Turkeys must not be slaughtered for food within five days after treatment. Swine must not be slaughtered for food within 48 hours after treatment. Honey Bees: The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks prior to main honey flow.

STORAGE AND HANDLING

Store at or below 25°C ( 77°F). Excursions permitted to 40°C (104°F). Avoid Moisture.

ADVERSE REACTIONS

To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-888-524-6332.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BILOVET 
tylosin tartrate powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5600
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TYLOSIN TARTRATE (UNII: 5P4625C51T) (TYLOSIN - UNII:YEF4JXN031)	TYLOSIN	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-5600-2	100 g in 1 PACKET
2	NDC: 61133-5600-1	100 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200455	05/15/2015

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)