Label: TYLOVET 100 - tylosin phosphate powder

  • Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated April 24, 2017

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  • Tylovet 100 Front Panel

    For use in Swine and Beef Cattle Feeds Only

    Tylovet®100

    Tylosin Phosphate

    Type A Medicated Article

    CAUTION: Federal law restricts medicated feed containing
    this veterinary feed directive (VFD) drug to use by or on
    the order of a licensed veterinarian.

    For Use in Swine and Beef Cattle Feeds Only

    Do Not Feed Undiluted


    Equivalent to 100 g Tylosin per Pound

    Swine:

    For the reduction in severity of effects of atrophic rhinitis.

    For control of swine dysentery associated with Brachyspira hyodysenteriae.

    For the treatment and control of swine dysentery associated with Brachyspira
    hyodysenteriae
    immediately after medicating with Tylovet Soluble (tylosin)
    drinking water.

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with
    Lawsonia intracellularis
    .

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with
    Lawsonia intracellularis
    immediately after medicating with Tylovet Soluble (tylosin)
    drinkng water.

    Beef Cattle:

    For reduction of incidence of liver abscesses associated with Fusobacterium
    necrophorum
    and Arcanobacterium pyogenes.

    Important: Must be Thoroughly Mixed in Feeds Before Use.Restricted Drug (California)  Use Only as Directed.ANADA# 200-484, Approved by FDAManufactured By: Biovet AD                                                         Distributed By: Huvepharma, Inc.39, Petar Rakov Str. 4550 Peshtera                                              525 Westpark Drive, Suite 230Bulgaria                                                                                       Peachtree, GA 30269

    Huvepharma®, and Tylovet® are trademarks of Huvepharma EOOD.
    To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

    Net weight: 50 lb (22.68 kg)

    HUVEPHARMA®

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  • Directions for Use

    Read all Directions Carefully Before Mixing and Feeding

    Tylovet® 100 Type A Medicated Article                           Net Weight: 50 lbs (22.68 kgs)

    Do Not Feed Undiluted

    CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

    Active Drug Ingredient: Tylosin (as tylosin phosphate)...100 g per lb
    Ingredients: Roughage products, pregelatanized starch and dipotassium phosphate.
    Caution: To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any
    liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate or complete feed) containing in excess of 2%
    bentonite.
    Warning: Tylovet 100 may be irritating to unprotected skin and eyes. When  mixing and handling Tylovet 100 use protective clothing, impervious gloves and a dust respirator. In case of accidental exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seed medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

    For the reduction in severity of effects of atrophic rhinitis. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed. Feed continuously as the sole ration.
    For control of swine dysentary. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pounds Tylovet 100 per ton) of complete feed until pigs reach market weight.
    For the treatment and control of swine dysentary.  Feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeksimmediately after medicating with 250 mg tylosin (as Tylosin Soluble) per gallon of drinking water for 3 to 10 days.
    For the control of porcine proliferative enteropathies. (PPE, ileitis). Feed 100 g tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per tone (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylovet Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylovet.

    NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.

    Mixing and Feeding
    Directions for Beef Cattle
     Feeds

    For reduction of incidence of
    liver abscesses associated with
    Fusobacterium necrophorum and Arcanobacterium pyogenes

    Tylovet 100 per Ton
    of Type C Feed

    0.08 to 0.10 lbs

    To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.

    Feed continuously as the sole ration.

    Tylosin Per Ton of Type C Feed

    8 to 10 g 

    ´╗┐Mixing Directions for Liquid Type B Cattle Feeds

    Limitaions

    1. pH must be between 4.5 and 6.0

    2. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top.

    Recirculate daily as described even when not used.

    3.For liquid feeds stored in mechanical, air, or other agitation - type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

    4. Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture.

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  • STORAGE AND HANDLING

    Store at Room Temperature, 25°C (77°F). Avoid moisture.
    Not to be used after the date printed on the bottom of the bag.

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  • Back Panel

    Tylovet® 100

    Tylosin Phosphate

    Type A Medicated Article

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  • Tylovet 100 Bag label
  • INGREDIENTS AND APPEARANCE
    TYLOVET 100  
    tylosin phosphate powder
    Product Information
    Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-2350
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TYLOSIN PHOSPHATE (UNII: NR75X12AFF) (TYLOSIN - UNII:YEF4JXN031) TYLOSIN 100 g  in 0.45 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23243-2350-1 22.68 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200484 03/01/2012
    Labeler - Huvepharma, Inc. (619153559)
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