Your browser does not support JavaScript! TYLAN 50 (TYLOSIN) INJECTION, SOLUTION [ELANCO ANIMAL HEALTH CO]

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TYLAN 50 (tylosin) injection, solution
[Elanco Animal Health Co]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL New Animal Drug Application
Drug Label Sections

Elanco™ AH0205 YL086437AMA

For Use In Cattle and Swine Only
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.

WARNINGS:

NOT FOR HUMAN USE, KEEP OUT OF REACH OF CHILDREN.

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. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.

RESIDUE WARNING: Swine:

Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product.

RESIDUE WARNING: Cattle:

Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/ or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. 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.

Store at or below 25°C (77°F)

Elanco, Tylan and the diagonal bar are trademarks owned or licensed by

Eli Lilly and Company, its subsidiaries or affiliates

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 – 100 mL Bottle Label

ELANCO™ AH 0205

For Use In Cattle and Swine Only

Tylan® 50

Tylosin

Injection

50 mg per mL TM

100 mL

Principal Display Panel – 100 mL Bottle Label

Principal Display Panel – 100 mL Carton Label

ELANCO™ AH 0205

For Use In Cattle and Swine Only

Tylan® 50

Tylosin

Injection

50 mg per mL TM

The Original Tylan 50

An Antibiotic For

Cattle

  • Pneumonia
  • Shipping
    Fever
  • Metritis
  • Diphtheria
  • Foot Rot

Swine

  • Pneumonia
  • Mycoplasmal
    Arthritis
  • Dysentery
  • Erysipelas

100 mL

Principal Display Panel – 100 mL Carton Label
TYLAN 50 
tylosin injection, solution
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:0986-0205
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TYLOSIN (TYLOSIN) TYLOSIN50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
BENZYL ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0986-0205-111 in 1 CARTON
1100 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01296507/01/2013
Labeler - Elanco Animal Health Co (807447169)
Establishment
NameAddressID/FEIBusiness Operations
Norbrook Laboratories Limited232880554MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Evonik Degussa Corporation130890994API MANUFACTURE

Revised: 7/2013
 
Elanco Animal Health Co

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