Overview

An overview of Ubac and why it is authorised in the EU

Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production. Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis).Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616.

Ubac is available as an injection and can only be obtained with a prescription. Ubac is given as a course of 3 injections into the neck muscles, alternating sides of the neck. The first injection is given at about 60 days before the expected calving date followed by a second injection given at least 3 weeks before the expected calving date. The third injection is given about 15 days after calving. The whole herd should be vaccinated. The full course should be repeated with each pregnancy. Protection starts about 36 days after the second injection and lasts for the first 5 months of lactation (milk production).

For more information about using Ubac, see the package leaflet or contact your veterinarian or pharmacist.

Ubac is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The active substance in Ubac is obtained from the sticky substances that the S. uberis bacteria produce to protect themselves and attach to surfaces (known as biofilm adhesion components). When Ubac is given to cattle, the animals’ immune system recognises the active susbstance as ‘foreign’ and makes antibodies against it. In the future, if the animals are exposed to disease-causing S. uberis bacteria, the immune system will be able to respond more quickly. This will help protect the cattle against the infection and reduce the risk of mastitis.

The vaccine also contains ‘adjuvants’ (Montanide ISA and MPLA) to stimulate a better reaction by the immune system.

A field study involved 6 farms with a history of S. uberis clinical mastitis and recently confirmed presence of S. uberis infection. During a 21 week observation period the incidence of new cases of S. uberis clinical mastitis was 50% lower in the group of 277 cattle vaccinated with Ubac compared to the group of 303 cattle given placebo (dummy treatment) (6.1% versus 12.2%).

The most common side effects with UBAC (which may affect more than 1 in 10 animals) are a short-lived increase in rectal temperature of around 1 - 2 ºC within 24 hours of injection and a local injection site swelling of more than 5 cm in diameter. The injection site swelling usually disappears or reduces in size by 17 days after vaccination but in some cases the swelling may last for up to 4 weeks.

For the full list of restrictions, see the package leaflet.

Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – this could result in the loss of the finger if prompt medical attention is not given. If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. The package leaflet should be shown to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before milk may be used for human consumption.

The withdrawal period for meat and milk from cattle treated with Ubac is ‘zero’ days, which means that there is no mandatory waiting time.

The European Medicines Agency decided that Ubac’s benefits are greater than its risks and it can be authorised for use in the EU.

Ubac received a marketing authorisation valid throughout the EU on 26 July 2018.

Ubac : EPAR - Summary for the public

български (BG) (110.16 KB - PDF)
español (ES) (75.35 KB - PDF)
čeština (CS) (98.72 KB - PDF)
dansk (DA) (73.17 KB - PDF)
Deutsch (DE) (76.45 KB - PDF)
eesti keel (ET) (73.18 KB - PDF)
ελληνικά (EL) (114.71 KB - PDF)
français (FR) (75.88 KB - PDF)
hrvatski (HR) (93.99 KB - PDF)
italiano (IT) (74.88 KB - PDF)
latviešu valoda (LV) (103.58 KB - PDF)
lietuvių kalba (LT) (97.64 KB - PDF)
magyar (HU) (95.07 KB - PDF)
Malti (MT) (99.16 KB - PDF)
Nederlands (NL) (74.62 KB - PDF)
polski (PL) (98.86 KB - PDF)
português (PT) (75.46 KB - PDF)
română (RO) (97.03 KB - PDF)
slovenčina (SK) (109.47 KB - PDF)
slovenščina (SL) (89.32 KB - PDF)
Suomi (FI) (74.96 KB - PDF)
svenska (SV) (73.93 KB - PDF)

Product information

Ubac : EPAR - Product Information

български (BG) (192.12 KB - PDF)
español (ES) (150.3 KB - PDF)
čeština (CS) (184.17 KB - PDF)
dansk (DA) (313.68 KB - PDF)
Deutsch (DE) (1016.03 KB - PDF)
eesti keel (ET) (288.66 KB - PDF)
ελληνικά (EL) (215.03 KB - PDF)
français (FR) (133.49 KB - PDF)
hrvatski (HR) (178.9 KB - PDF)
íslenska (IS) (150.77 KB - PDF)
italiano (IT) (148.84 KB - PDF)
latviešu valoda (LV) (186.66 KB - PDF)
lietuvių kalba (LT) (185.13 KB - PDF)
magyar (HU) (184.1 KB - PDF)
Malti (MT) (197.4 KB - PDF)
Nederlands (NL) (150.48 KB - PDF)
norsk (NO) (147.2 KB - PDF)
polski (PL) (190.11 KB - PDF)
português (PT) (150.24 KB - PDF)
română (RO) (188 KB - PDF)
slovenčina (SK) (192.81 KB - PDF)
slovenščina (SL) (175.16 KB - PDF)
Suomi (FI) (140.32 KB - PDF)
svenska (SV) (148.98 KB - PDF)

Latest procedure affecting product information: IB/0006

03/12/2021

Ubac : EPAR - All Authorised presentations

български (BG) (69.36 KB - PDF)
español (ES) (51.54 KB - PDF)
čeština (CS) (64.48 KB - PDF)
dansk (DA) (51.94 KB - PDF)
Deutsch (DE) (51.92 KB - PDF)
eesti keel (ET) (50.14 KB - PDF)
ελληνικά (EL) (67.29 KB - PDF)
français (FR) (50.47 KB - PDF)
hrvatski (HR) (58.19 KB - PDF)
íslenska (IS) (51.61 KB - PDF)
italiano (IT) (51.88 KB - PDF)
latviešu valoda (LV) (68.57 KB - PDF)
lietuvių kalba (LT) (64.34 KB - PDF)
magyar (HU) (61.03 KB - PDF)
Malti (MT) (66.91 KB - PDF)
Nederlands (NL) (51.58 KB - PDF)
norsk (NO) (51.64 KB - PDF)
polski (PL) (67.68 KB - PDF)
português (PT) (51.24 KB - PDF)
română (RO) (85.92 KB - PDF)
slovenčina (SK) (60.14 KB - PDF)
slovenščina (SL) (74.76 KB - PDF)
Suomi (FI) (51.51 KB - PDF)
svenska (SV) (52.18 KB - PDF)

Product details

Name of medicine
Ubac
Active substance
Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616
International non-proprietary name (INN) or common name
Streptococcus uberis vaccine (inactivated)
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) code
QI02AB

Pharmacotherapeutic group

Immunologicals for bovidae

Therapeutic indication

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.

Authorisation details

EMA product number
EMEA/V/C/004595
Marketing authorisation holder
Laboratorios Hipra, S.A.

Avda. La Selva,
135 Amer
17170 Girona
Spain

Marketing authorisation issued
26/07/2018
Revision
1

Assessment history

Ubac : EPAR - Procedural steps taken and scientific information after authorisation

Ubac : EPAR - Public assessment report

CVMP summary of positive opinion for UBAC

Topics

This page was last updated on

How useful do you find this page?