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Date: Friday, March 29, 2024 6:19

Release 5.140
Orbeseal Dry Cow Intramammary Suspension
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow (non antibacterial), Pharmaceuticals: Miscellaneous
Active ingredient: Bismuth Subnitrate
Product:OrbeSeal® Dry Cow Intramammary Suspension
Product index: OrbeSeal
Cattle - milk: Zero days
Cattle - meat: Zero days
Incorporating:
Presentation
A greyish white smooth, unctuous suspension, presented in syringes each containing 4 g intramammary suspension containing 65% bismuth subnitrate, heavy.
Uses
For the prevention of new intramammary infections throughout the dry period in cattle.
In cows likely to be free of subclinical mastitis, the veterinary medicinal product can be used on its own in dry cow management and mastitis control.
Dosage and administration
For intramammary use only.
Infuse the contents of one intramammary syringe of the veterinary medicinal product 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 veterinary medicinal product .
Care must be taken not to introduce pathogens into the teat in order to reduce the risk of post-infusion mastitis.
It is essential that the teat is thoroughly cleaned and disinfected with surgical spirit or alcohol-impregnated wipes. The teats should be wiped until the wipes are no longer visibly dirty. Teats should be allowed to dry prior to infusion. Infuse aseptically and take care to avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.
Under cold conditions the veterinary medicinal product may be warmed to room temperature in a warm environment, to aid syringeability.
Contra-indications, warnings, etc
Selection of cows for treatment with the veterinary medicinal product 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 bacteriological sampling.
Since the veterinary medicinal product does not have antimicrobial activity, in order to minimize the risk of acute mastitis due to poor infusion technique and lack of hygiene, it is crucial to follow the aseptic technique of administration described in the Further Information section.
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Acute mastitis1
1 Primarily due to poor infusion technique and lack of hygiene. Please refer to the Further Information section regarding the importance of aseptic technique.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system.
Do not use the veterinary medicinal product alone in cows with subclinical mastitis at drying off. The compatibility of the veterinary medicinal product has only been shown with a cloxacillin-containing dry cow preparation.
Do not administer any other intramammary veterinary medicinal product following administration of the veterinary medicinal product. In cows that may have subclinical mastitis, the veterinary medicinal product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.
Do not use in cows with clinical mastitis at drying off.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Twice the recommended dose has been administered to cows with no clinical adverse effects.
Do not use during lactation. If accidentally used in a lactating cow, a small (up to 2-fold) transient rise in somatic cell count may be observed. In such an event, strip out the seal manually. No additional precautions are necessary.
To reduce the risk of contamination, do not immerse the syringe in water.
Withdrawal periods
Meat and offal: Zero days
Milk: Zero days
Operator warnings
The veterinary medicinal product may cause skin and eye irritation. 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 label to the doctor.
People with known hypersensitivity to bismuth salts should avoid contact with the veterinary medicinal product.
Wash hands after use.
Pharmaceutical precautions
No special precautions are necessary for storage. Use the syringe only once.
Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
24 syringe cartons and 120 syringe tubs are available.
Further information
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 therapy is instituted.
As the veterinary medicinal product is not absorbed following intramammary infusion, it can be used in pregnancy. At calving the seal may be ingested by the calf and produces no adverse effects.
The veterinary medicinal product is not absorbed from the mammary gland, but forms a seal in the teat until physically removed. Infusion of the veterinary medicinal product into each udder quarter produces a seal in the teat that provides an immediate and long lasting physical barrier to entry of bacteria and other mastitis causing organisms.
Care must be taken not to introduce pathogens into the teat. It is essential that strict aseptic techniques are used for the infusion of the veterinary medicinal product as it possesses no antimicrobial activity. For best results the following steps are recommended:
1All teats need to be thoroughly cleansed and disinfected prior to infusion of the veterinary medicinal product. Ensure sufficient time is allocated to treat each animal and do not combine this with other husbandry activities.
2Ensure animals are appropriately restrained in hygienic conditions. Keep syringes clean and DO NOT immerse in water.
3A separate pair of clean disposable gloves should be worn for the treatment of each cow.
4Start 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.
5Thoroughly 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 cleaning swabs can be used. Clean the teats furthest away from you first, to avoid contaminating clean teats.
6Gently scrub each teat end with new individual, disposable spirit/alcohol swabs, until both teat end and swab are visibly clean.
7Remove the cap from the intramammary tube, being careful not to touch the nozzle.
8Grip the teat base firmly between your fingers at the junction with the udder. Turn the teat to a slight angle. 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.
9Apply 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.
Failure to follow these recommendations can possibly lead to post-infusion mastitis, or in extreme cases, death.
After calving, the following steps are recommended for the effective removal of the veterinary medicinal product to minimise residues entering the milking machine. The milking machine should not be used to remove the veterinary medicinal product from the teat.
10Pinch teat at the top and strip quarter 10-12 times prior to first milking.
11Strip foremilk and check for residues for first few milkings.
12Inspect mastitis filters and milk sock for evidence of residues after every milking.
Marketing Authorisation Number
UK(GB): Vm 42058/5106
UK(NI): Vm 42058/3007
Significant changes
GTIN
GTIN description:24 syringes:
GTIN:05013457078992
GTIN description:120 syringes:
GTIN:05013457079005