Patient leaflet - Ubac
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
UBAC emulsion for injection for cattle
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release :
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
UBAC emulsion for injection for cattle.
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (2 ml) contains:
Active substances:
Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis , strain 5616..................................................................................................................................> 1 RPU
Relative Potency Units (ELISA)
Adjuvant:
907.1 mg
Montanide ISA
Monophosphoryl Lipid A (MPLA)
Emulsion for injection.
White homogeneous emulsion.
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4. INDICATION(S)
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.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
Local swelling more than 5 cm 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 (e.g. 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:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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.
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7. TARGET SPECIES
Cattle.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program:
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– First dose at approximately 60 days before the expected parturition date
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– Second dose at least 21 days before the expected parturition date
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– Third dose should be administered about 15 days after the calving.
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.
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9. ADVICE ON CORRECT ADMINISTRATION
The injections should be preferably 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.
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10. WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated.
Protect from light.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Only healthy animals should be immunised.
The whole herd should be immunised.
Immunisation has to be considered as one component in a complex mastitis 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 animals :
To the user:
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 very 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.
Pregnancy and Lactation :
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) :
No information is available.
Incompatibilities :
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY