KERASEAL

COMPOSITION

A syringe (4 g) contains 

Active substance

Bismuth subnitrate 65%                                 

TARGET SPECIES

Cattle (dairy cows)

INDICATIONS

Indications for use, specifying target species

It is indicated for the prevention of new intramammary infections during the dry periods. It is recommended to be used as part of a herd approach to cow management during dry periods and for mastitis control

In cows considered free of subclinical mastitis, Keraseal can be used during the dry periods. 

Other animals should be monitored in accordance with an approved mastitis control plan under the supervision of the veterinarian.

The selection of cattle for treatment with Keraseal should be based on a prior investigation by the veterinarian. 

As a guideline, when individual cell counts are available, cows having an average cell count of less than 200,000/mL before dry periods can be treated with Keraseal. A slight increase in the number of cells in the last 4 weeks before dry periods is normal and can be ignored.

CONTRAINDICATIONS

Do not use the product alone in cows with subclinical mastitis during dry periods. Do not use in cows with clinical mastitis during dry periods. Do not use in lactating cows. If accidentally used in a lactating cow, there is a transient (2-fold) increase in somatic cells. In such a case, the product shall be hand-cleansed and no further precautions are required. Do not administer any other intramammary product after administration of Keraseal.

ADVERSE REACTIONS

If adverse reactions or other secondary effects not mentioned in this leaflet are noted, please inform your vet.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Dose and administration:

For intramammary infusion only. Dose: Inject the contents of a Keraseal syringe into each quarter breast immediately after the last milking (during dry periods). Do not massage the nipple or the udder after the infusion of the product. 

Administration: Care must be taken not to introduce pathogens into the nipple. It is important to observe a strict aseptic technique for administering Keraseal because the product has no antimicrobial activity. 

All nipples should be carefully disinfected before Keraseal injection. Make sure you have enough time to treat each animal. Do not combine this practice with other zootechnical activities.

Ensure that animals are properly immobilised, under hygienic conditions. Keep the syringes clean and do NOT put them in water. 

A pair of disposable gloves should be used to treat each individual animal. 

Start with visibly clean and dry nipple. If the nipples are visibly dirty, clean the dirt around them with damp disposable napkins and dry well. Soak the nipple and let it work for 30 seconds, then wipe each nipple with disposable napkins until it is completely dry. Drain the milk into a cup and then dispose of it.

Carefully disinfect the entire nipple surface with a napkin soaked in alcohol. Studies indicate the use of recently made cotton swabs soaked in alcohol (or alcohol equivalents) as the most effective way of cleaning. 

Remove the lid of the intrammary tube, taking care not to touch the nozzle. Inject the contents of the syringe into the nipple, avoiding contamination. Inject nipples in the reverse order of cleaning, for example: first treat the quarter closest to you. Do not massage the udder.

Apply a post-milking disinfectant to the nipple and take the treated animals in an area where they will stay for at least 30 minutes to allow the nipple channel closure.

At calving, the ingestion of Keraseal in the calf is safe and does not produce adverse effects.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

User warnings

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

Care must be taken to maintain cleanliness when administering Keraseal in order to reduce the risk of death by post-infusion mastitis.

Complete tips on nipple cleaning before injection are included in the instructions for use and should be followed strictly.

WITHDRAWAL PERIOD(S)

Meat and offal 0 days.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25 °C. Keep in a dry place.

SPECIAL WARNING(S)

In cows that may have subclinical mastitis, Keraseal can be used after the administration of an antibiotic therapy to the infected quarter. In clinical trials, the compatibility of Keraseal has only been demonstrated with cloxacillin. Like all intramammary treatments, it is a good practice, to observe the cows in the dry period frequently, to note any signs of clinical mastitis. If one of the mammary quarters develops clinical mastitis, the respective quarter should be emptied manually before the necessary therapy is administered. Use the syringe only once. To reduce the risk of contamination, do not insert the syringe into water. Wash hands after using the product. Because the product is not absorbed after injection, Keraseal can be used in pregnant animals. For veterinary use only.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Wash hands after using the product.

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

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste.

OTHER INFORMATION

Most products that seal tightly are removed during the first milking or because of the calf’s effect on the nipple, small amounts of product can also be seen for a few days (like small spots on the filter). Keraseal can be distinguished from mastitis by its texture. Twice the recommended dose was administered to cows without having any side effects. Under cold conditions, the product can be brought to room temperature in a warm environment to aid in infusion.

After calving, the following steps are recommended for effectively eliminating the product, to minimize the entry of residual product into the milking equipment. The milking equipment should not be used to remove Keraseal from the nipple.

Pinch the nipple 10-125 times before the first milking.

For the first milking: check if the product contains residual material.

Check the filters after each milking to avoid residual product.

PRESENTATION/PACKAGE

White low-density polyethylene syringes.