TYLOVET (TYLOSIN TARTRATE) POWDER, FOR SOLUTION [HUVEPHARMA, INC.]

TYLOVET (TYLOSIN TARTRATE) POWDER, FOR SOLUTION [HUVEPHARMA, INC.]
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NDC 23243-2220-1, 23243-2220-2
Set ID bb913f0b-79c4-43d1-94d0-291b15d50321
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Huvepharma, Inc.
Generic Name
Product Class
Product Number
Application Number ANADA200473
  • 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 Tylovet Type A medicated article in feed. For the control of
    porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when
    followed immediately by Tylovet 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
    Tylovet 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 pouch 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)*:

    Desired Concentration
    in Drinking water
    Pouches of Tylovet SolubleVolume of Water to Make Stock Solution
    250 mg/gallon (66 ppm)13 gallons + 13 ounces
    851 mg/gallon (225 ppm)54 gallons + 77 ounces
    1,419 mg/gallon (375 ppm)95 gallons + 0 ounces
    2,000 mg/gallon (528 ppm)103 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.

  • INSTRUCTIONS 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 Tylovet 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 Tylovet
    Type A medicated article) for 2 to 6 weeks. Only medicated water should be available to swine while
    medicating with Tylovet 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 Tylovet A medicated article) for 2 to 6 weeks. Only medicated water should be
    available to swine while medicating with Tylovet 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.

  • 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.

  • SAFETY INFORMATION

    User Safety Warnings: Keep Out of Reach of Children. Avoid contact with 

    human skin. Exposure to tylosin may cause a rash.

  • HOW SUPPLIED

    How supplied:
    Tylovet® Soluble is supplied in pouches of laminated aluminum foil, 100 g of tylosin activity
    per pouch; or HDPE jars with PP cap with heat sealable coating, 100 g of tylosin activity per jar.

  • STORAGE

    Storage:
    Store at Room Temperature, 25°C (77°F).
    Excursions Permitted to 40°C/104°F. Avoid moisture.

  • TOP AND BOTTOM LABEL TEXT

    Tylovet® 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, ANADA# 200-473, Approved by FDA Product 2220

    Restricted Drug (California) - Use only as Directed
    ANADA # 200-473, Approved by FDA
    To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.
    Manufactured for: Huvepharma Inc. Peachtree City, GA 30269 , Made in Bulgaria
    Tylovet® is a registered trademark of Huvepharma EOOD

    Lot: 00000000000 Exp. Date: 00.0000 Code: LB444v4-Tyl100-USA1017

  • POUCH LABEL IMAGE

    POUCH LABEL IMAGE

  • POUCH LABEL IMAGE 2

    POUCH LABEL IMAGE 2

  • INGREDIENTS AND APPEARANCE
    TYLOVET 
    tylosin tartrate powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-2220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TYLOSIN TARTRATE (UNII: 5P4625C51T) (TYLOSIN - UNII:YEF4JXN031) TYLOSIN100 g  in 3970 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-2220-1100 in 1 CASE
    13790 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20047301/01/2011
    Labeler - Huvepharma, Inc. (619153559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biovet Joint Stock Company645015512api manufacture, manufacture, analysis, pack, label

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