TYLAN SOLUBLE- tylosin tartrate powder
Tylan Soluble by
Drug Labeling and Warnings
Tylan Soluble by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., TriRx Speke Limited, AndersonBrecon Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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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.
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Dosages:
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 -
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.
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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.
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
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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
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INGREDIENTS AND APPEARANCE
TYLAN SOLUBLE
tylosin tartrate powderProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 58198-1300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tylosin tartrate (UNII: 5P4625C51T) (tylosin - UNII:YEF4JXN031) tylosin tartrate 100 g in 3785 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58198-1300-1 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA013076 12/23/2011 Labeler - Elanco US Inc. (966985624)
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