UBAC Emulsion for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Biofilm Adhesion Component (BAC) of Streptococcus uberis

Available from:

Laboratorios Hipra SA

ATC code:

QI02AB

INN (International Name):

Biofilm Adhesion Component (BAC) of Streptococcus uberis

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2018-07-26

Summary of Product characteristics

Unlimited Renewal: January 2023
AN: 03163/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UBAC emulsion for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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:
Montanide
ISA.................................................................................................907.1
mg
Monophosphoryl Lipid A (MPLA)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogeneous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
None.
Unlimited Renewal: January 2023
AN: 03163/2022
Page 2 of 5
4.4
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the