Tylan 50

Dosage Form: FOR ANIMAL USE ONLY
Tylan®50

Tylosin Injection

50 mg per mL

For Use In Cattle and Swine Only

ELANCO* AH 0205-82X

An Antibiotic

Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes. In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.

ADMINISTRATION AND DOSAGE: Tylan 50 Injection is administered intramuscularly.

BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 6.25 pounds). Treatment should be continued 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site.

This formulation is recommended for use in calves weighing less than 200 pounds.

SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 12.5 pounds) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site.

Read accompanying directions fully before use.

CAUTION: Do not mix Tylan 50 Injection with other injectable solutions as this may cause a precipitation of the active ingredients. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.

PRECAUTION: Adverse reactions, including shock and death may result from overdosage in baby pigs. Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL) unless the syringe is capable of accurately delivering 0.1 mL.

If tylosin medicated drinking water is used as a follow-up treatment for swine dysentery the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.

NOT FOR HUMAN USE

WARNING: Discontinue use in cattle 21 days before slaughter. Discontinue use in swine 14 days before slaughter.

Do not use in lactating dairy cattle.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Store at 72°F (22°C) or below.

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

Restricted Drug (California) - Use Only as Directed.

NADA 12-965, Approved by FDA

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

Manufactured for: Elanco Animal Health

A Division of Eli Lilly and Company

Indianapolis, IN 46285, USA

Principal Display Panel

Principal Display Panel – 100 mL Bottle Label

ELANCO* AH 0205-82X

Tylan® 50

Tylosin

Injection

50 mg per mL

For Use In Cattle and Swine Only

100 mL

An Antibiotic

Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes. In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.

ADMINISTRATION AND DOSAGE: Tylan 50 Injection is administered intramuscularly.

Manufactured for: Elanco Animal Health

A Division of Eli Lilly and Company

Indianapolis, IN 46285, USA

YL9500DEAMB (V01-08-2009)

Principal Display Panel

Principal Display Panel – 100 mL Carton Label

ELANCO* AH 0205-82X

Tylan® 50

Tylosin

Injection

50 mg per mL

For Use In Cattle and Swine Only

100 mL

The Original Tylan 50

An Antibiotic For

Cattle

• Pneumonia


• Shipping
  
  Fever


• Metritis


• Diphtheria


• Foot Rot

Swine

• Pneumonia


• Mycoplasmal
  
  Arthritis


• Dysentery


• Erysipelas

100 mL

Tylan 50  tylosin  injection, solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 0986-0205 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TYLOSIN (TYLOSIN) TYLOSIN 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   BENZYL ALCOHOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0986-0205-11 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 100 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (0986-0205-11)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA12965	06/03/2010

Labeler - Elanco Animal Health Co (807447169)

Establishment
Name	Address	ID/FEI	Operations
Norbrook Laboratories Limited		232880554	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Evonik Degussa Corporation		130890994	API MANUFACTURE

Revised: 06/2010Elanco Animal Health Co