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Tylan 200

Elanco Animal Health Co

Tylan 200 Tylosin Injection 250 mL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Elanco™
AH0206
YL086436AMA

For Use In Cattle and Swine Only
200 mg per mL

An Antibiotic

Uses

Indications: In Beef Cattle and Non-lactating Dairy Cattle, Tylan 200 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 200 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 200 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 200 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 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.

SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 50 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 200 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 25 pounds (0.5 mL), with the common syringe. It is recommended that Tylan 50 Injection be used in pigs weighing less than 25 pounds.

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 – 250 mL Bottle Label

Elanco™ AH0206

Tylan ® 200

Injection TM

250 mL

Tylosin

For Use In Cattle and Swine Only

200 mg per mL

Principal Display Panel – 250 mL Carton Label

Elanco™ AH0206

Tylan ® 200

Injection TM

200 mg per mL

Tylosin

For Use In Cattle and Swine Only

The Original Tylan 200

An Antibiotic

For Cattle Diseases

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

For Swine Diseases

  • Pneumonia
  • Mycoplasmal Arthritis
  • Dysentery
  • Erysipelas

250 mL

Tylan 200

TYLOSIN INJECTION, SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:0986-0206
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TYLOSIN TYLOSIN 200 mg

Inactive Ingredients

Ingredient Name Strength
propylene glycol
BENZYL ALCOHOL
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 250 in 1 BOTTLE, GLASS
2 NDC:0986-0206-05 500 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA012965 2013-07-08


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