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Date: Monday, May 6, 2024 7:17

Release 3.1016
Ubroseal Blue Dry Cow 2.6 g intramammary suspension for cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Dry cow (non antibacterial)
Active ingredient: Bismuth Subnitrate
Product:Ubroseal Dry Cow 2.6 g intramammary suspension for cattle
Product index: Ubroseal
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Presentation
Blue intramammary suspension. Each 4 g intramammary syringe contains:
Active ingredient: 2.6 g Bismuth subnitrate, heavy
Excipient: 0.02g Indigo Carmine AL Lake E 132
Uses
Prevention of new intramammary infections throughout the dry period.
In cows considered likely to be free of sub-clinical mastitis, the product can be used on its own in dry cow management and mastitis control.
Selection of cows for treatment with the 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 sub-clinical mastitis or bacteriological sampling.
Target Species
Cattle (dairy cows at drying off)
Dosage and administration
For intramammary use only.
Infuse the contents of one syringe of the 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 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 product may be warmed to room temperature in a warm environment to aid syringeability.
Care must be taken not to introduce pathogens into the teat. It is essential that strict aseptic techniques are used for the infusion of this product as it possesses no antimicrobial activity. 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 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 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.
Contra-indications, warnings, etc
Contraindications
Do not use in lactating cows. Do not use the product alone in cows with sub-clinical mastitis at drying off. Do not use in cows with clinical mastitis at drying off.
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
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. To reduce the risk of contamination, do not immerse the syringe in water. Use the syringe only once. It is important to observe strict aseptic technique for the administration of the product because the product does not have antimicrobial activity. Do not administer any other intramammary product following administration of this product. In cows that may have sub-clinical mastitis, the product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
The cleaning towels provided with the intramammary product contain isopropyl alcohol. Wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.
Use during pregnancy, lactation or lay
Pregnancy: Can be used during pregnancy. At calving, the seal may be ingested by the calf. Ingestion of the product by the calf is safe and produces no adverse effects.
Lactation: This product is contra-indicated for 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.
Adverse Reactions
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Twice the recommended dose has been administered to cows with no clinical adverse effects.
Withdrawal period(s)
Meat and offal: Zero days.
Milk: Zero hours.
Interaction with other medicinal products and other forms of interaction
None known.
Pharmaceutical precautions
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months
Do not store above 25°C. Protect from light.
For animal treatment only.
Keep out of the sight and reach of children.
To be supplied only on veterinary prescription.
Major incompatabilities
None known.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
A 4g polyethylene intramammary syringe consisting of a barrel with plunger and a polyethylene dual-cap
Cardboard box of 20 syringes and 20 cleaning towels
Polyethylene bucket of 60 syringes and 60 cleaning towels
Polyethylene bucket of 120 syringes and 120 cleaning towels
Not all pack sizes may be marketed
Marketing Authorisation Holder (if different from distributor)
Univet Ltd
Tullyvin
Cootehill
Co. Cavan
Ireland
Further information
Advice to herdsmen
It is important that you read the instructions before using this product. Great care should be taken in maintaining cleanliness when administering this product 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.
Pharmacodynamic properties
Infusion of the product into each udder quarter produces a physical barrier against the entry of bacteria thereby reducing the incidence of new intramammary infections during the dry period.
Pharmacokinetic particulars
Bismuth subnitrate is not absorbed from the mammary gland, but resides as a seal in the teat until physically removed (shown in cows with a dry period up to 100 days).
Excipients
Paraffin, liquid; Aluminium Di Tri Stearate; Silica, colloidal anhydrous; Indigo Carmine AL Lake E 132
Other Information
Infusion of the product into each udder quarter produces a physical barrier against the entry of bacteria thereby reducing the incidence of new intramammary infections during the dry period.
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. The product can be differentiated from mastitis by its texture.
After calving, the following steps are recommended for the effective removal of the product to minimise residual product entering the milking machine. The milking machine should not be used to remove the product from the teat.
1Pinch the teat at the top and strip quarter 10-12 times prior to first milking.
2Strip foremilk and check for residual product for first few milkings.
3Inspect mastitis filters and milk sock for evidence of residual product after every milking.
Marketing Authorisation Number
Vm 05150/4006
Significant changes
GTIN
GTIN description:120 x 4g
GTIN:5012917012132