Nobivac Bb
Authorised
This medicine is authorised for use in the European Union
live vaccine against Bordetella bronchiseptica in cats
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Nobivac Bb is a dry substance and solvent that are made up into a suspension, which is given via the nose.
Nobivac Bb is used to vaccinate cats aged one month or older against the disease (a flu-like illness) caused by the bacterium B. bronchiseptica.
Cats are vaccinated by giving a 0.2-ml dose into one nostril. Immunity against infection is usually established after around three days and lasts for up to a year.
Nobivac Bb is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2. When a cat is given the vaccine, the immune system recognises the bacteria as ‘foreign’ and makes a special type of antibody against them. In the future, the immune system will be able to produce these antibodies more quickly when it is again exposed to the bacteria. The live bacterium strain included in Nobivac Bb differs from other types of B. bronchiseptica because it is missing certain molecules and is therefore less likely to cause disease. This makes it suitable for use in a vaccine. Vaccines against B. bronchiseptica that are administered through the nose are also used in dogs.
The effectiveness of Nobivac Bb was investigated in three main studies involving cats of various breeds. The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica. Nobivac Bb was the first live B. bronchiseptica vaccine licensed for use in cats.
The main studies showed that Nobivac Bb was effective in reducing the symptoms caused by B. bronchiseptica.
Occasional side effects include sneezing, coughing and a mild and temporary discharge from the eyes or nose. In animals that show more severe signs, treatment with an antibiotic may be necessary.
The vaccine may be administered by veterinarians only. In case of accidental administration to people seek medical advice immediately and show the package leaflet or label to the doctor. Although the risk for people with weak immune systems becoming infected with B. bronchiseptica is extremely low, it is advised that cats which are in close contact with such people are not vaccinated with Nobivac Bb, since they can shed the bacteria intermittently for up to a year after vaccination.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Bb exceed the risks of its use. The benefit-risk balance may be found in module 6 of this EPAR.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B.V. on 10 September 2002. The marketing authorisation was renewed on 25 September 2007. Information on the prescription status of this product may be found on the label / outer package.
Product information
Latest procedure affecting product information:
IAIN/0012
17/10/2014
Product details
- Name of medicine
- Nobivac Bb
- Active substance
- live Bordetella bronchiseptica bacteria strain B-C2
- International non-proprietary name (INN) or common name
- live vaccine against Bordetella bronchiseptica in cats
- Species
- Cats
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI06AE02
Pharmacotherapeutic group
Immunologicals for felidaeTherapeutic indication
For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Duration of immunity: The duration of immunity is up to 1 year.
No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available. From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
News on Nobivac Bb
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