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Tylosin Injection200 mg/mL

Product Type: OTC ANIMAL DRUG LABEL
Autor Name: Boehringer Ingelheim Vetmedica, Inc.
Code Source: 0010-6879
Route of Administration: INTRAMUSCULAR

Tylosin

Generic: Tylosin

Ingredients:

  • TYLOSIN TYLOSIN : Active ingredient - basis of strength - 200 mg in 1 mL
  • PROPYLENE GLYCOL : Inactive ingredient - 0.5 mL in 1 mL
  • BENZYL ALCOHOL : Inactive ingredient - 0.04 mL in 1 mL
  • WATER : Inactive ingredient

Package Description:

  • 250 mL in 1 BOTTLE, GLASS
  • 500 mL in 1 BOTTLE, GLASS

NADA 138-955, Approved by FDA
Antibiotic - Sterile
For use in animals only.

Description

Tylosin Injection is available in a concentration of 200 mg/mL tylosin base. The product is recommended for intramuscular injection only in beef cattle, nonlactating dairy cattle and swine.
Each mL contains:
Tylosin Base ............................200.0 mg
Propylene Glycol .....................50% v/v
Benzyl Alcohol .........................4% v/v
Water for Injection ...................q.s.

Indications

Tylosin 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 beef cattle and nonlactating dairy cattle.
In swine, Tylosin 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 ; and acute swine dysentery associated with Brachyspira ( formerly Serpulina or Treponema) hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

Dosage and Administration

For intramuscular injection only.
Beef Cattle and Nonlactating Dairy Cattle - Inject intramuscularly 8 mg per pound of body weight (1 mL per 25 pounds) once daily. Treatment should be continued 24 hours after symptoms of the disease have stopped, not to exceed 5 days. Do not inject more than 10 mL per site. The 50 mg 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 50 pounds) twice daily. Treatment should be continued 24 hours after symptoms of the disease have stopped, not to exceed 3 days. Do not inject more than 5 mL per injection site.

Side Effects

Side effects consisting of 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.

Caution

Do not mix Tylosin Injection with other injectable solutions as this may cause precipitation of the active ingredients. Do not administer to horses or other equine species. Injection of tylosin in equines has been fatal.

Precautions

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). It is recommended that Tylosin Injection 50 mg/mL 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.

Storage

Store at 72 °F (22°C) or below.

How Supplied

Tylosin Injection, 200 mg/mL is available in 250 mL and 500 mL vials. The 500 mL size is for use via automatic syringe only.

Keep out of reach of children. For use in animals only.
Restricted Drug (California): Use only as directed.
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.
687901L-02-0308
Code 687921

250 mL Bottle Label



Picture of 250 mL container label
Tylosin Injection200 mg/mL

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