Ubac

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI02AB

INN (International Name):

Streptococcus uberis vaccine (inactivated)

Therapeutic group:

Cattle

Therapeutic area:

Immunologicals for bovidae

Therapeutic indications:

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.

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2018-07-26

Patient Information leaflet

11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
Cardboard box with 20 glass vials of 1 dose.
Cardboard box with 1 PET vial of 5, 25 and 50 doses.
Vial of 25 and 50 doses.
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UBAC emulsion for injection for cattle
2.
STATEMENT OF ACTIVE SUBSTANCES
One dose (2 ml) contains:
Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of
_Streptococcus uberis_
, strain
5616
≥ 1 RPU*
*Relative Potency Units (ELISA)
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
PACKAGE SIZE
20 x 1 dose (1 vial of 2 ml)
5 doses (1 vial of 10 ml)
25 doses (1 vial of 50 ml)
50 doses (1 vial of 100 ml)
25 doses (50 ml)
50 doses (100 ml)
5.
TARGET SPECIES
Cattle
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD(S)
Withdrawal period: Zero days.
12
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached use immediately.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Protect from light.
Do not freeze.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only. To be supplied only on veterinary
prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/18/227/001-004
17.
MANUFACTURER’S BATCH NUMBER
Batch {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial label 1 dose and 5 doses
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UBAC emulsion for injection for cattle
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
LTA from BAC of
_Streptococcus uberis_
, strain

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
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.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the
veterinary medicinal p