Ubac

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

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About

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.

How is Ubac used?

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.

How does Ubac work?

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.

What benefits of Ubac have been shown in studies?

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%).

What are the risks associated with Ubac?

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.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

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.

What is the withdrawal period in food-producing animals?

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.

Why is Ubac authorised in the EU?

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

Other information about Ubac

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

Name Language First published Last updated
Ubac : EPAR - Summary for the public BG = bălgarski 2018-08-14  
Ubac : EPAR - Summary for the public ES = español 2018-08-14  
Ubac : EPAR - Summary for the public CS = čeština 2018-08-14  
Ubac : EPAR - Summary for the public DA = dansk 2018-08-14  
Ubac : EPAR - Summary for the public DE = Deutsch 2018-08-14  
Ubac : EPAR - Summary for the public ET = eesti keel 2018-08-14  
Ubac : EPAR - Summary for the public EL = elliniká 2018-08-14  
Ubac : EPAR - Summary for the public EN = English 2018-08-14  
Ubac : EPAR - Summary for the public FR = français 2018-08-14  
Ubac : EPAR - Summary for the public IT = italiano 2018-08-14  
Ubac : EPAR - Summary for the public LV = latviešu valoda 2018-08-14  
Ubac : EPAR - Summary for the public LT = lietuvių kalba 2018-08-14  
Ubac : EPAR - Summary for the public HU = magyar 2018-08-14  
Ubac : EPAR - Summary for the public MT = Malti 2018-08-14  
Ubac : EPAR - Summary for the public NL = Nederlands 2018-08-14  
Ubac : EPAR - Summary for the public PL = polski 2018-08-14  
Ubac : EPAR - Summary for the public PT = português 2018-08-14  
Ubac : EPAR - Summary for the public RO = română 2018-08-14  
Ubac : EPAR - Summary for the public SK = slovenčina 2018-08-14  
Ubac : EPAR - Summary for the public SL = slovenščina 2018-08-14  
Ubac : EPAR - Summary for the public FI = suomi 2018-08-14  
Ubac : EPAR - Summary for the public SV = svenska 2018-08-14  
Ubac : EPAR - Summary for the public HR = Hrvatski 2018-08-14  

This EPAR was last updated on 14/08/2018 .

Authorisation details

Product details

Product details for Ubac
NameUbac
Agency product numberEMEA/V/C/004595
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) codes QI02AB



Publication details

Publication details for Ubac
Marketing-authorisation holder

Laboratorios Hipra, S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union26/07/2018

Contact address:

Laboratorios Hipra, S.A.
Avda. La Selva,
135 Amer
17170 Girona
Spain

Product information

Product information

26/07/2018  Ubac -EMEA/V/C/004595

Name Language First published Last updated
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  
Ubac : EPAR - Product Information HR = Hrvatski 2018-08-14  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  
Ubac : EPAR - All Authorised presentations HR = Hrvatski 2018-08-14  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Ubac : EPAR - Public assessment report HR = Hrvatski 2018-08-14  
CVMP summary of positive opinion for UBAC HR = Hrvatski 2018-05-28  

Authorised

This medicine is approved for use in the European Union