Summary of product characteristics

	Download Nobivac Bb SPC as PDF file from EMEA website
	English Spanish Portuguese French German Italian Dutch Swedish Danish Finnish Greek
	Acrobat Reader

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Solvent
Water for injections

3. PHARMACEUTICAL FORM

4. IMMUNOLOGICAL PROPERTIES

ATC vet code: QI 06AE02.

5. CLINICAL PARTICULARS

Cats.

5.2 Indications for use

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.

5.3 Contra-indications

None known.

5.4 Undesirable effects

Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose. In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.

5.5 Special precaution(s) for use

Only healthy cats should be vaccinated.

Sneezing by cats after administration does not adversely affect the efficacy of the product.

Do not administer during antibiotic treatment or in conjunction with any other intranasal products.

Vaccinated animals can spread the vaccine strain of Bordetella bronchiseptica for six weeks, and there may be intermittent shedding for at least one year.

Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats, which are in close contact with immunocompromised humans are not vaccinated with this vaccine.

Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs. Other animals, such as rabbits and small rodents, have not been tested.

5.6 Use during pregnancy and lactation

Do not use in pregnant or lactating queens.

5.7 Interaction with other veterinary medicinal products and other forms of interaction

No information is available on the safety and efficacy from the use of this vaccine with any other. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product.

5.8 Posology and method of administration

Vaccination scheme: One dose of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.

Allow the solvent to reach room temperature (15 - 25°C). Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided. Shake well after addition of the solvent. Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat's nostrils.

The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is forced to breathe through its nostrils. Place the syringe in front of one of the nostrils and carefully administer the whole contents of the syringe into the nasal cavity via this nostril. The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.

5.9 Overdose

Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose, particularly in very young susceptible kittens. In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.

5.10 Special warnings for each target species

If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.

Vaccinated animals can spread the Bordetella bronchispetica vaccine strain for six weeks; in individual cases for at least one year. Intermittent spreading is possible as well.

5.11 Withdrawal period

Not applicable.

5.12 Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-administration, seek medical advise immediately and show the package insert or the label to the physician.

Appropriate disinfection procedures should be used following use of this live bacterial vaccine.

Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica is extremely low, such individuals should be aware that cats can shed the organism for up to 1 year after vaccination.

6. PHARMACEUTICAL PARTICULARS

In the absence of incompatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.

6.2 Shelf-life

2 years.

After reconstitution the product should be used within 4 hours.

6.3 Special precautions for storage

Store at 2 - 8°C. Protect from light.

6.4 Nature and contents of container

One 3 ml unit-dose vial (glass Type I) of powder sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent.

5 unit-dose vials of powder and 5 vials of solvent per carton.

6.5 Special precautions for the disposal of unused products or waste materials

Dispose of waste material that has had contact with the active substance by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

7. NAME OR CORPORATE NAME AND CORPORATE ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORISATION HOLDER

PROHIBITION OF SALE, SUPPLY AND/OR USE

MARKETING AUTHORISATION NUMBER(S)

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

DATE OF REVISION OF THE TEXT

Back

[Nobivac® Bb for cats] [Vaccination video] [Why intranasal?] [Guidelines for use] [Vaccination method] [Registration studies] [Publications] [SPC] [Talk to owners] [Vets FAQ] [Logout]