Orbeseal®

Dry cow teat sealant suspension

Each 4 g intramammary syringe contains 65 % bismuth subnitrate in a mineral oil vehicle

Orbeseal® is indicated for the prevention of new intramammary infections throughout the dry period.

The non-antibiotic dry cow treatment prevents new intramammary infections throughout the dry period with a zero milk and meat withdrawal period.

It is recommended that Orbeseal can be used as part of a herd approach to dry cow management and mastitis control. Cows considered likely to be free of subclinical mastitis can be given Orbeseal at drying off. Other animals should be managed in accordance with an approved mastitis control plan or specific veterinary advice.

Withdrawal period for meat and milk is zero days.

It is important that the instructions are read before using this product. Great care should be taken in maintaining cleanliness when administering Orbeseal in order to reduce the risk of potentially fatal post-infusion mastitis. Full advice on teat cleaning technique prior to tubing is included in the instructions and should be followed.

Selection of cows for treatment should be based on veterinary clinical judgement. Selection criteria may be based on the mastitis and cell count history of individual cows or recognised tests for the detection of subclinical mastitis or bacteriology sampling.

Keep out of reach of children, uninfomed persons and animals.

Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

Special precautions for use in animals

As with all dry cow intramammary treatments, it is good practice to observe dry cows regularly for signs of clinical mastitis. If a sealed quarter develops clinical mastitis, the affected quarter should be stripped out manually before appropriate antibiotic therapy is instituted.

Do not administer any other intramammary product following the administration of Orbeseal.

In cows that may have subclinical mastitis, Orbeseal may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.

Since the product does not have antimicrobial activity, in order to minimise the risk of acute mastitis due to poor infusion technique and lack of hygiene, it is crucial to follow aseptic technique of administration described in Directions for Use.

Use syringe only once.

To reduce the risk of contamination, do not immerse syringes in water.

If any serious effects are noticed, or other effects not mentioned in this leaflet, please inform the Veterinarian.

Dispose of any unused product, seal stripped from an animal at calving, or waste material in accordance with local waste management practices.

Special precautions to be taken by the person administering the veterinary product to animals

This product may cause skin and eye irritation.

Avoid contact with skin and eyes.

Should skin or eye contact occur, was the affected area thoroughly with water.

If irritation persists, seek medical advice and show this label to the physician.

If you know you are allergic to bismuth salts, avoid using the product.

Wash hands after use.

Adverse reactions

Acute mastitis has been reported very rarely (less than 1 animal in 10 000 animals treated, including isolated reports) after use of this product, primarily due to poor infusion technique and lack of hygiene. Refer to Precautions and Directions for Use regarding the importance of aseptic technique.

Use during pregnancy and lactation

Pregnancy:

As the product is not absorbed following intramammary infusion, Orbeseal can be used in pregnant animals. At calving, the seal may be ingested by the calf. Ingestion of Orbeseal by the calf is safe and produces no adverse effects.

Lactation:

The product is contraindicated for use during lactation. [Do not use in the lactating cow.] If lactating cows are accidentally infused, a small (up to 2-fold) transient rise in somatic cell count may be observed. In such an event, strip out the seal manually, [but the seal can easily be stripped out manually and] no additional precautions are necessary

Use only as directed.

For intramammary infusion only.

Dosage:

One syringe into each udder quarter immediately after last milking of the lactation (at drying off). Do not massage the teat or udder after infusion.

Administration:

Care must be taken not to introduce pathogens into the teat. Failure to follow these recommendations can lead to serious cases of post-infusion mastitis and even death.

1. All teats need to be thoroughly cleansed and disinfected prior to infusion of Orbeseal®. Ensure sufficient time is allocated to treat each animal and do not combine this with other husbandry activities.

2. Ensure animals are appropriately restrained in hygienic conditions. Keep syringes clean and DO NOT immerse in water.

3. A separate pair of clean, disposable gloves should be worn for the treatment of each cow.

4. Start with a visibly clean, dry teat and udder. If teats are obviously dirty, then clean off dirt from the teats only with moistened disposable paper towels and dry thoroughly. Dip teats in rapid-acting pre-dip, leave for 30 seconds, and then wipe each teat completely dry with separate disposable paper towels. Strip foremilk into a strip cup and discard.

5. Thoroughly disinfect the whole surface of the teat with a disposable spirit/alcohol-soaked swab. Studies indicate that the most effective means of teat-cleaning involves the use of swabs freshly prepared from clean, dry cotton wool, soaked in surgical spirits (or equivalent). If this is not available, then the supplied sterile swabs can be used. Clean the teats furthest away from you first, to avoid contaminating clean teats.

6. Gently scrub each teat end with new, individual disposable spirit/alcohol swabs until both teat end and swab are visibly clean.

7. Remove the cap from the intramammary tube, being careful not to touch the nozzle. Infuse the contents of the syringe into the teat, avoiding contaminating the teat end. Do not massage the product into the udder.

8. Apply a post-milking teat disinfectant and confine the treated cows to a yard where they should stand for at least 30 minutes to allow the teat canal to close.

Store at or below 25 °C.

Bucket containing 144 x 4 g syringes.