Animal NDC 61133-4011-2 Bilovet
Tylosin
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 61133-4011-2 |
| Proprietary Name | Bilovet What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Tylosin What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Bimeda, Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | ANADA200508 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Bilovet Images
Bilovet Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description
BiloVet®
(tylosin injection)
For Use in Cattle and Swine Only
Use automatic syringe equipment only
200 mg per mL
An Antibiotic
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Indications & Usage
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.
Dosage & Administration
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
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
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.
Storage And Handling
STORE AT 20°C-25°C (68°F -77°F). Use within 28 days of first puncture and puncture a maximum of 5 times with automatic syringe equipment. When using a draw-off spike or needle larger than 4-gauge, discard any product remaining in the vial immediately after use.
Other
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.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.