TYLAN SOLUBLE (TYLOSIN TARTRATE) POWDER [ELANCO US INC.]

TYLAN SOLUBLE (TYLOSIN TARTRATE) POWDER [ELANCO US INC.]
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NDC 58198-1300-1
Set ID 0c3d01b7-be57-4031-adbe-5dbdd2a6d7f2
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number NADA013076
  • SPL UNCLASSIFIED SECTION

    Elanco™

    AF1300

    Tylan™ Soluble

  • Indications

    Chickens: For the control of mortality caused by necrotic enteritis (NE) associated with Clostridium perfringens in broiler chickens. As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens. For the control of CRD associated with Mycoplasma gallisepticum at the time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae 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 SD associated with Brachyspira hyodysenteriae when followed immediately by Tylan Type A medicated article in feed. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by Tylan Type A medicated article in feed.

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

    Ingredients

    Tylosin (as tylosin tartrate).........................................................................................100 g

    Dosage and Administration

  • Dosages:

    Chickens:

    NE indication: 851 to 1,419 mg/gallon (225 to 375 ppm) in drinking water.

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

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

    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 Tylan Soluble 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 jar 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 851 to 1,419 mg/gallon (225 to 375 ppm), mix this concentrated solution with water to make from 117 gallons + 51 ounces (444 liters) to 70 gallons + 64 ounces (267 liters) of medicated drinking water, respectively. 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)*:

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

    Desired Concentration in Drinking water Jars of Tylan Soluble Volume of Water to Make Stock Solution
    250 mg/gallon (66 ppm) 1 3 gallons + 13 ounces
    851 mg/gallon (225 ppm) 5 4 gallons + 77 ounces
    1,419 mg/gallon (375 ppm) 9 5 gallons + 0 ounces
    2,000 mg/gallon (528 ppm) 10 3 gallons + 115 ounces

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

  • Directions for Use

    Chickens: NE indication: Administer medicated drinking water for a single five day period in broiler chickens. To assure all birds receive the intended medication, only medicated water should be available. These practices should be followed to assure both food safety and responsible antimicrobial drug use in chickens: 1) Use in flocks exhibiting signs of a necrotic enteritis outbreak, for example, increased mortality and lesions characteristic of necrotic enteritis upon necropsy; 2) Administer the full dose and dosing regimen once medication is initiated; 3) Use of Tylan Soluble or another macrolide is not advised if additional therapy is needed beyond the original course of medication. 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 tylosin per ton of complete feed (Type C medicated feed manufactured from Tylan Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble. 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 Tylan A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while medicating with Tylan Soluble.

    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.

  • Warnings

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

    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.

    Manufactured For:
    Elanco US, Inc.
    Greenfield, IN 46140 U.S.A.
    Product of the United Kingdom

  • STORAGE AND HANDLING

    Store at or below 25°C (77°F)

    Excursions Permitted to 40°C (104°F)

    Avoid Moisture.

    Restricted Drug (California) – Use Only as Directed.

    To report suspected adverse events, for technical assistance, or to obtain a Material Safety Data Sheet (MSDS), call 1-800-428-4441.

    Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    Lot/Exp. Date

    47801-04

  • Principal Display Panel - Tylan Soluble Bottle Label

    Elanco™

    AF1300

    Tylan™ Soluble

    Tylosin Tartrate

    Equivalent to 100 g (3.53 oz) tylosin base

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

    For oral use in chickens, turkeys, swine, and honey bees.

    Macrolide Antibiotic, NADA 13-076, approved by FDA

    Principal Display Panel - Tylan Soluble Bottle Label
  • INGREDIENTS AND APPEARANCE
    TYLAN SOLUBLE 
    tylosin tartrate powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58198-1300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031) tylosin tartrate100 g  in 3785 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-1300-13785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01307612/23/2011
    Labeler - Elanco US Inc. (966985624)

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