KERASEAL

2.6 g/syringe, dry cow intramammary suspension

Indications

Prevention of new intramammary infections throughout the dry period.

In cows considered likely to be free of sub-clinical mastitis, Keraseal can be used on its own in dry cow management and mastitis control. Selection of cows for treatment with Keraseal should be based on veterinary clinical judgement. Selection criteria may be based on the mastitis and cell count history of individual cows or recognized tests for the detection of subclinical mastitis or bacteriology sampling. As a guide, where individual cell counts are available, cows with an average cell count less than 200,000 cells/ml may be given Keraseal. A minor increase in cell count during the last 4 weeks before drying off is normal and may be ignored.

COMPOSITION

Each syringe of 4 g contains:

Bismuth subnitrate, heavy    2.6g

 

CONTRAINDICATIONS

Do not use Keraseal  in cows with sub-clinical mastitis at drying off. Do not use in cows with clinical mastitis at drying off.

Do not use in animals that are known to be hypersensitive to the active substance or to any of the excipients.

 

ADVERSE REACTIONS

None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For intramammary infusion only.

Infuse the contents of one syringe of Keraseal into each udder quarter immediately after the last milking of the lactation (at drying off).

Do not massage the teat or udder after infusion of the product.

 

Administration:

Care must be taken not to introduce pathogens into the teat in order to reduce the risk of post-infusion mastitis. Since the product does not have antimicrobial activity, it is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated wipes. 

 

1.  All teats need to be thoroughly cleansed and disinfected prior to infusion of the product. 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 teats only, with moistened disposable paper towels and dry thoroughly. Dip teats in a rapid-acting pre-dip, leave for 30 seconds, then wipe each teat completely dry with separate disposable paper towels. Strip fore milk 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 spirit (or the 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 bottom portion of the teat below where you are pinching the teat avoiding contaminating the teat end. Infuse teats in the opposite order to cleaning i.e. treat the quarters closest to you first. 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.

 

At calving ingestion of the product by the calf is safe and produces no adverse effects.

 

ADVICE ON CORRECT ADMINISTRATION

User warnings

It is important to read the instructions before using this product.

Great care should be taken in maintaining cleanliness when administering Keraseal 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. Under cold conditions the product may be warmed to room temperature in a warm environment, to aid syringeability.

 

WITHDRAWAL PERIODS

Meat: zero days.

Milk: zero hours.

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 250C.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

 

SHELF-LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.

 

SPECIAL WARNINGS

Special precautions for use

Special precautions for use in animals

In cows that may have subclinical mastitis, the product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter. In clinical trials, the compatibility of the product has only been shown with a cloxacillin containing dry cow preparation. 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. To reduce the risk of contamination, do not immerse syringes in water. Use syringe only once.

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

Avoid contact with skin or eyes. Should skin or eye contact occur, wash the affected area thoroughly with water. If irritation persists, seek medical advice and show the package leaflet to the doctor. If you know that you are allergic to bismuth salts, avoid using this product. Wash hands after use.

Pregnancy and lactation

As Keraseal is not absorbed following intramammary infusion, it can be used in pregnant animals.

Keraseal is contra-indicated for use during lactation. 

Interactions with other medicinal products and other forms of interaction

Do not administer other intramammary products after administration of Keraseal.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Twice the recommended dose has been administered to cows with no clinical adverse effects.

 

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

 

OTHER INFORMATION

Most of the seal comes out at the first stripping or suckling after calving, but small amounts may occasionally be seen for a few days as flecks on the filter. Keraseal can be differentiated from mastitis by its texture.

After calving, the following steps are recommended for the effective removal of Keraseal to minimize residual product entering the milking machine. The milking machine should not be used to remove Keraseal from the teat.

1. Pinch the teat at the top and strip quarter 10-12 times prior to first milking.

2. Strip colostrum and check for residual product for first few milkings.

3. Inspect mastitis filters and milk sock for evidence of residual product after every milking.

 

PRESENTATION/PACKAGE

A single dose intramammary syringe made of low-density polyethylene with a smooth, tapered hermetically sealed nozzle, containing 4 g of product.


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