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Date: Sunday, May 19, 2024 0:01

Release 3.313
UBAC Emulsion for Injection for Cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:UBAC Emulsion for Injection for Cattle
Product index: UBAC Injection for Cattle
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Presentation
White homogenous emulsion for injection for cattle
Uses
For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by Streptococcus uberis, to reduce the somatic cell count in Streptococcus uberis positive quarter milk samples and to reduce milk production losses caused by Streptococcus uberis intramammary infections.
Onset of immunity: approximately 36 days after the second dose.
Duration of immunity: approximately the first 5 months of lactation.
Dosage and administration
Intramuscular use
Administration: Administer one dose (2ml) by deep intramuscular injection in the neck muscles according to the following immunisation program:
-First dose at approximately 60 days before the expected parturition date
-Second dose at least 21 days before the expected parturition date
-Third dose should be administered about 15 days after calving.
The injections should preferably be administered on the alternate sides of the neck.
Allow the vaccine to reach a temperature of +15 to +25 °C before administration.
Shake before use.
Protection of animals not vaccinated following this program has not been demonstrated. This should be considered in case of herd vaccination.
The full immunisation program should be repeated with each gestation.
One 2ml Dose Contains:
Active substance: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ≥ 1 RPU*
*Relative Potency Units (ELISA)
Adjuvants: Monotanide ISA 907.1 mg; Monophosphoryl Lipid A (MPLA)
Additional Information for Northern Ireland
Excipients: Disodium phosphate dodecahydrate; Potassium dihydrogen phosphate; Sodium chloride; Potassium chloride; Water for injections
Contra-indications, warnings, etc
Contra-indications: None
Special warnings for each target species; Vaccinate healthy animals only. The whole herd should be immunised. Immunisation has to be considered as one component in a complex intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals; This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician; This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions (frequency and seriousness)
Local swelling more than 5cm in diameter at the injection site is a very common reaction after administration of the vaccine. This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination. However, in some cases, swelling may persist for up to 4 weeks.
A transient increase in rectal temperature (mean increase of 1 °C but may be up to 2 °C in individual animals) may very commonly occur in the first 24 hours after injection.
Anaphylactic-type reactions (eg. oedema) which might be life-threatening, may occur very rarely in some sensitive animals based on post-marketing safety experience. Under these circumstances, appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals treated displaying adverse reaction(s))
-common (more than 1 but less than 10 in 100 animals treated)
-uncommon (more than 1 but less than 10 in 1000 animals treated)
- rare (more than 1 but less than 10 in 10,000 animals treated)
-very rare (less than 1 animal in 10,000 animals treated including isolated reports)
Use during pregnancy, lactation or lay; Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction; No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Overdose (symptoms, emergency procedures, antidotes), if necessary: No information is available.
Withdrawal period(s); Zero days
Pharmaceutical precautions
Pharmacotherapeutic group; Immunologicals for bovidae, inactivated bacterial vaccines for cattle. ATC vet code: Q102AB18.
Subunit vaccine to stimulate immunity against Streptococcus uberis.
Do not mix with any other veterinary medicinal product.
Shelf life; Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage; Store and transport refrigerated (2°C - 8°C) and protected from light. Do not freeze.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products; Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Nature and composition of immediate packaging;
Type I colourless glass vials of 3ml. Polyethylene (PET) vials of 10, 50 and 100ml. The vials are closed with a rubber stopper and aluminium cap.
Pack sizes;
Cardboard box with 20 glass vials of 1 dose (2ml).
Cardboard box with 1 PET vial of 5 doses (10ml).
Cardboard box with 1 PET vial of 25 doses (50ml).
Cardboard box with 1 PET vial of 50 doses (100ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
LABORATORIES HIPRA, S.A.
Avda. la Selva, 135
17170- AMER (Girona)
SPAIN
Tel +34 972 430660
Fax +34 972 430661
E-mail: hipra@hipra.com
Further information
In a multicentre field study , the incidence of new cases of Streptococcus uberis clinical intramammary infection in the group vaccinated with UBAC was 50% lower than the incidence in the placebo group (6.1% vs 12.2%) which was statistically significant different (p=0.012). Bearing in mind that some cows had suffered more than one episode of Streptococcus uberis clinical intramammary infection, the incidence of cows with clinical intramammary infection was 52.5% lower in the vaccinated group than those of the placebo group (4.7% versus 9.9%), with a statistical significance of p<0.017.
Marketing Authorisation Number
UK(GB): Vm 17533/5011
UK(NI): EU/2/18/227/001-004
Significant changes
GTIN
GTIN description:UBAC 1 DOSE
GTIN:8427711183211
GTIN description:UBAC 5 DOSE
GTIN:8427711183228
GTIN description:UBAC 25 DOSE
GTIN:8427711183235