Animal NDC 58198-1300-1 Tylan Soluble
Tylosin Tartrate
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 58198-1300-1 |
| Proprietary Name | Tylan Soluble What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Tylosin Tartrate What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Elanco Us Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | NADA013076 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
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Tylan Soluble Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Other
Elanco™
AF1300
Tylan™ Soluble
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).
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 use in Honey Bees: Mix 200 mg tylosin in 20 g confectioners/powdered sugar. Use immediately.
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.
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.
Do not use in layers producing eggs for human consumption.
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. Store at or below 25°C (77°F)
Greenfield, IN 46140 U.S.A. Excursions Permitted to 40°C (104°F)
Product of the United Kingdom Avoid Moisture.
Ingredients
Tylosin (as tylosin tartrate).........................................................................................100 g
Dosage And Administration
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.
| *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 |
Storage And Handling
To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2022 Elanco or its affiliates
Lot/Exp. date
47801-07
YL103717X
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
Approved by FDA under NADA # 013-076
YL103717X
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.