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Tylan Soluble

Generic Name: tylosin tartrate powder
Dosage Form: FOR ANIMAL USE ONLY

Tylan® Soluble
Tylosin Tartrate

For Use In Chickens, Turkeys, Swine and Honey Bees Only
ELANCO*
AF 1300-67X
Equivalent to 100 g tylosin base
An Antibiotic NADA #13-076, Approved by FDA

Indications

Chickens: As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of CRD associated with Mycoplasma gallisepticum sensitive to tylosin at the time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.

Turkeys: For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.

Swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae. For the treatment and control of swine dysentery 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

Mixing Directions

Chickens and Turkeys: To assure thorough dissolution, place the Tylan (contents of this jar) in a mixing container and add one gallon of water (3790 mL) to the material. Mix this concentrated solution with water to make 50 gallons (189 liters) of treated drinking water.

Swine: To assure thorough dissolution, place the Tylan (contents of this jar) in a mixing container and add one gallon of water (3790 mL) to the material. Mix this concentrated solution with water to make 400 gallons of treated drinking water resulting in 250 mg/gallon.

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

When directed to mix the product with water, always add the water to the powder. Do not pour the powder into the water. Prepare a fresh Tylan solution every three days. When mixing and handling tylosin, use protective clothing and impervious gloves.

Directions for Use

Chickens should be treated for three days; however, treatment 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 should be treated for three days; however, treatment 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 For the treatment and control of swine dysentery medicate with 250 mg tylosin per gallon in drinking water for 3 to 10 days, depending upon severity of infection. Alternatively, medicate with 250 mg tylosin per gallon in 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. For control of porcine proliferative enteropathies (PPE, ileitis) medicate with 250 mg tylosin per gallon in 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 Type A medicated article) for 2 to 6 weeks. Swine must consume enough medicated water to provide a therapeutic dose. Only medicated water (250 mg tylosin per gallon) should be available while medicating with Tylan Soluble.

Honey Bee colonies should receive three treatments administered as a dust in confectioners/powdered sugar. The 200 mg dose is applied (dusted) over the top bars of the brood chamber once weekly for 3 weeks.

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.

NOT FOR HUMAN USE

RESIDUE WARNING: Chickens must not be slaughtered for food within 24 hours after treatment. Turkeys must not be slaughtered for food within five days after treatment. Swine must not be slaughtered for food within 48 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.

Avoid contact with human skin. Exposure to tylosin may cause a rash.

Store at Room Temperature, 25°C (77°F).
(Excursions Permitted to 40°C).
Avoid Moisture.

Manufactured For:
Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, USA

Restricted Drug (California) - Use Only as Directed.

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

*Elanco®, Tylan® and the diagonal color bar are trademarks of Eli Lilly and Company.

Lot/Exp. date YL0091DEAMX (V01-08-2008)

Principal Display Panel

Principal Display Panel – 100 g Bottle Label
ELANCO*
AF 1300-67X
Tylan® Soluble
Tylosin Tartrate
For Use In Chickens, Turkeys, Swine and Honey Bees Only
Equivalent to 100 g tylosin base
An Antibiotic NADA #13-076, Approved by FDA

Tylan Soluble 
tylosin tartrate powder
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0986-1300
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TYLOSIN TARTRATE (TYLOSIN) TYLOSIN TARTRATE 100 g  in 3790 mL
Packaging
# Item Code Package Description
1 NDC:0986-1300-11 3790 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA13076 05/10/2010
Labeler - Elanco Animal Health Co (807447169)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 043911403 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Eli Lilly and Company Limited (Speke Operations) 230761368 API MANUFACTURE
Revised: 05/2010
 
Elanco Animal Health Co



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