Orbeseal

Company: Zoetis

Dry Cow Intramammary Teat Sealant Device

Non-antibiotic

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

Orbeseal is a sterile, antibiotic-free, off-white smooth paste. It is presented, ready to use, in syringes, each containing 4 g of intramammary infusion composed of 65% Bismuth Subnitrate, in a mineral oil vehicle. Orbeseal 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 Orbeseal 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 Orbeseal is administered following an antibiotic infusion, the withdrawal periods for meat and milk for the antibiotic must be observed.

Precautions

Keep out of reach of children. For animal treatment only. If Orbeseal gets on skin, wash with soap and warm water. If accidentally administered to a lactating cow, product can be stripped out by hand. A SDS may be obtained by calling Zoetis Inc. Customer Support at 1-888-963-8471.

Adverse Reactions

Mastitis-causing bacteria introduced into the teat at the time of infusion of Orbeseal have been associated with adverse reactions. Each teat must be cleaned and disinfected prior to infusion of Orbeseal. See below for instructions for administration of infusion products.

Storage

Orbeseal should be stored at room temperature 60°-85°F (~15°-30°C). In very cold temperatures Orbeseal may become difficult to administer and should be warmed to room temperature. Individual tubes should not be immersed in water. The Orbeseal bucket can be lowered into a 5 gallon bucket filled with warm water to warm the tubes.

Orbeseal Indications

Orbeseal is intended as an aid in the prevention of new intramammary infections of dairy cattle throughout the dry period.

Dosage and Administration

After last milking at dry-off, clean and disinfect the teats using an appropriate antiseptic teat wipe (containing at least 70% isopropyl alcohol). Infuse the entire contents of one syringe of Orbeseal into each quarter by inserting the nozzle into the teat and applying gentle 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 an appropriate antiseptic teat wipe (containing at least 70% isopropyl alcohol) prior to infusion with Orbeseal. A clean, disinfected and dry teat is essential, as Orbeseal possesses no antimicrobial activity. It is advisable to use an appropriate teat disinfectant following the infusion.

REMOVAL: Do not remove Orbeseal by action of the milking machine. To reduce the potential for Orbeseal accumulation in milking machines, aggressively hand-strip Orbeseal 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 an appropriate antiseptic teat wipe (containing at least 70% isopropyl alcohol) and leave to air 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 Orbeseal.

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.

Use Only as Directed

Not for Human Use

Distributed by:

Zoetis Inc., Kalamazoo, MI 49007

Revised: February 2023

CPN: 3690220.3