Dosage Form: FOR ANIMAL USE ONLY
Tylan® 200
tylosin
Injection
For Use in Swine, Beef Cattle
and Non-lactating Dairy Cattle Only
NADA 12-965 Approved by FDA
DESCRIPTION:
Tylan 200 Injection is a sterile solution of tylosin base in 50% propylene glycol with 4% benzyl alcohol and water for injection. Each mL contains 200 mg of tylosin activity (as tylosin base).
ACTIONS:
Tylan has an antibacterial spectrum that is essentially gram-positive, but it is also active against certain spirochetes, large viruses, and certain gram-negative organisms (not including coliforms). It has also been found to be active against certain Mycoplasma species.
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 Actinomyces pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Actinomyces 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.
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.
SIDE EFFECTS:
Side effects consisting of an edema of the rectal mucosa, anal protrusion, diarrhea, erythema, and pruritus have been observed in some hogs following the use of tylosin. Discontinuation of treatment effected an uneventful recovery from the reaction.
CAUTION:
Do not mix Tylan 200 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.
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.
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.
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.
HOW SUPPLIED:
Tylan 200 Injection is supplied in 100 mL, 250 mL, and 500 mL vials with aluminum sealed rubber stoppers.
Store at 72°F (22°C) or below.
*Elanco® and Tylan® are trademarks of Eli Lilly and Company.
Text revised: April, 2004
Literature revised: April, 2004
Manufactured for:
Elanco Animal Health
A Division of Eli Lilly and Company
Indianapolis, IN 46285, USA
To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.
PA9021DEAMP (I-APR-04)
Principal Display Panel
Principal Display Panel – 250 ml Bottle Label
ELANCO* AH 0206-38W
Tylan® 200
Tylosin
Injection
200 mg per mL
For Use In Cattle and Swine Only
An Antibiotic
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 Actinomyces pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Actinomyces 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.
250 mL
Principal Display Panel – 250 ml Carton Label
ELANCO* AH 0206-38W
Tylan® 200
Tylosin
Injection
200 mg per mL
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
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| 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 | |
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