BOVISEAL- bismuth subnitrate paste
Bimeda, Inc. Division of Cross Vetpharm Group
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Each syringe contains 4 g intramammary paste
Containing 65% Bismuth Subnitrate
For use in nonlactating dairy cattle
FOr animal use only
Read Entire Package Insert Carefully Before Using This Product
Boviseal is a sterile, antibiotic-free, off white smooth paste. It is presented, ready to use, in syringes, each containing 4g of intramammary infusion composed of 65% Bismuth Subnitrate, in a mineral oil vehicle. Boviseal is indicated as an aid in the prevention of new intramammary infection throughout the dry period by providing a malleable barrier in the teat canal. This results in a reduction in the incidence of clinical mastitis in the dry period.
It is recommended that Boviseal be used as part of a herd approach to dry cow management and mastitis control.
WITHDRAWAL INFORMATION: For use in dry cows only. Zero-day milk and meat withdrawal when used alone. If Boviseal is administered following an antibiotic infusion, the withdrawal periods for meat and milk for the anitbiotic must be observed.
PRECAUTIONS: Keep out of reach of children. For animal treatment only. If Boviseal gets on skin, wash with soap and warm water. If accidentally administered to lactating cow, product can be stripped out by hand. A MSDS may be obtained by calling Bimeda Customer Support at 1-888-254-6332.
REMOVAL: Do not remove Boviseal by action of the milking machine. To reduce the potential for Boviseal accumulation in milking machines, aggressively hand-strip Boviseal out of every quarter, 10 to 12 strips per quarter, before milking fresh cows. Bucket-milk fresh cows for a minimum of three milkings, if possible.
Simple steps to avoid introducing infections during administration of intramammary infusions.
1. Do not place individual syringes in warm/hot water during cold weather.
2. Dry cows off abruptly rather than gradually.
3. Clean teat ends as thoroughly as possible with alcohol and leave air to dry. DO NOT use water with or without disinfectant.
4. Clean the two teats furthest away first, followed by the two closest.
5. Ensure the teats are clean and dry before infusing Boviseal.
6. Infuse the teats in the opposite order to cleansing: i.e. infuse the closest two teats first, followed by the two furthest away.
7. After infusing, dip teats in teat dip or spray with disinfectant and leave cows standing in yard for at least half an hour to allow the teat canal to close.
8. Check cows regularly for signs of mastitis during the first week after drying off.
ADVERSE REACTIONS: Mastitis causing bacteria introduced into the teat at the time of infusion of Boviseal have been associated with adverse reactions. Each teat must be cleaned and disinfected prior to infusion of Boviseal. See below for instructions for administration of infusion products.
STORAGE: Boviseal should be stored below 25 degrees C (77degrees F). In very cold temperatures Boviseal may become difficult to administer and should be warmed to room temperature. Individual tubes should not be immersed in water. The Boviseal bucket can be lowered into a 5 gallon bucket filled with warm water to warm the tubes.
INDICATIONS: Boviseal is intended as an aid in the prevention of new intramammary infections of dairy cattle throughout the dry period.
DOSAGE AND ADMINISTRATION:
After the last milking at dry-off, clean and disinfect the teats with the alcohol swabs provided. Infuse the entire contents of one syringe of Boviseal into each quarter by inserting the nozzle into the teat and applying gently continuous pressure to the plunger until the paste is expressed. Do not massage teat or udder following infusion. If an antibiotic is infused into the teat, the teat should be re-swabbed with the alcohol swab provided prior to infusion with Boviseal. A clean, disinfected and dry teat is essential, as Boviseal possesses no antimicrobial activity. It is advisable to use an appropriate teat disinfectant followint the infusion.
| BOVISEAL
bismuth subnitrate paste |
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| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (060492923) |
| Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (060492923) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Bimeda, Inc., Division of Cross Vetpharm Group | 060492923 | manufacture | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| 5N Plus Lubeck GmbH | 316594993 | api manufacture | |