BiloVet: Product Information

BILOVET- tylosin injection, solution
Bimeda, Inc.

INDICATIONS: In Beef Cattle and Non-lactating Dairy Cattle, BiloVet 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, BiloVet 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% propylene glycol with 4% benzyl alcohol, water for injection and hydrochloric acid for pH adjustment.

ADMINISTRATION AND DOSAGE: BiloVet is administered intramuscularly.

Use automatic syringe equipment only

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 BiloVet 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 tylosin 50 mg/mL injection be used in pigs weighing less than 25 lbs.

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.

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 20°C-25°C (68°F -77°F).

Restricted Drug (California) – Use Only as Directed

Approved by FDA under ANADA # 200-508

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae.

BiloVet® is a registered trademark of Bimeda, Inc.

Manufactured for:

Bimeda, Inc.

Le Sueur, MN 56058

www.bimeda.com

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BILOVET
tylosin injection, solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-4011
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TYLOSIN (TYLOSIN) TYLOSIN 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
BENZYL ALCOHOL
water
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61133-4011-2 250 mL in 1 BOTTLE, GLASS None
2 NDC:61133-4011-3 500 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200508 06/30/2021
Labeler — Bimeda, Inc. (060492923)
Establishment
Name Address ID/FEI Operations
Bimeda- MTC 256232216 manufacture
Establishment
Name Address ID/FEI Operations
Biovet 645015512 api manufacture
Establishment
Name Address ID/FEI Operations
Shandong Lukang Shelile Pharmaceutical Co. Ltd. 554404761 api manufacture

Revised: 01/2022 Bimeda, Inc.

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