Nobivac® Respira Bb

Nobivac® Respira Bb is a vaccine for active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection

FOR ANIMAL USE ONLY

Nobivac® Respira Bb

Reg. No. G4506 (Act 36/1947)

Suspension for Injection

INDICATIONS

INDICATIONS

For active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection.

IMMUNITY

Onset of immunity:                   2 weeks.

Duration of immunity:             7 months after primary vaccination.

                                                         1 year after re-vaccination.

COMPOSITION

Each dose (1 mℓ) contains:

Active substance

Bordetella bronchiseptica fimbriae1:                  88 – 399 U2

1 Purified from strain Bb7 92932

2 Antigenic mass ELISA units

Adjuvant

dl-α-tocopheryl acetate:                                      74,7 mg

Excipient

Thiomersal:                                                               0,15 mg

STORAGE INSTRUCTIONS

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Store in the original package in order to protect from light.
  • Once the multi-dose vial is broached, it should be stored between 2 °C and 25 °C and used within 4 weeks.

WARNINGS

  • Vaccinate healthy animals only.
  • Do NOT mix Nobivac® Respira Bb with any other veterinary medicinal product, except those specifically mentioned under the section “INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION”.
  • Do not over- or underdose the vaccine.
  • Nobivac® Respira Bb is safe for use during pregnancy; however, the safety has not been investigated during the first 20 days of gestation.
  • In case of accidental self-injection, seek medical advice immediately and show this package leaflet to the physician.
  • Do not inject intravenously.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Do not eat, drink or smoke whilst handling the product.
  • Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Inject subcutaneously with 1 mℓ per dose.

Dogs can be vaccinated from the age of 6 weeks onwards.

Allow the vaccine to reach room temperature (15 °C to 25 °C) before use.

For the multi-dose vial – Shake well before each administered dose. Avoid introduction of contamination by using a clean needle for each administered dose.

Primary vaccination:

Two vaccinations with an interval of 4 weeks.

Re-vaccination:

A single vaccination, administered 7 months after the primary vaccination, is sufficient to maintain protection against Bordetella bronchiseptica for another year. Thereafter, a single vaccination should be administered, annually. In case re-vaccination at 7 months is missed, a single vaccination within 12 months after primary vaccination is sufficient to extend protection against Bordetella bronchiseptica for another year.

Nobivac® Respira Bb can also be used for re-vaccination in a schedule where Nobivac® KC has been used for primary vaccination. A single vaccination, administered 1 year after primary vaccination with Nobivac® KC, is sufficient to prolong immunity against Bordetella bronchiseptica for another year.

Re-vaccination after primary vaccination with Nobivac® KC:

One vaccination, annually.

For associated use:

When Nobivac® Respira Bb is administered in associated use (i.e., not mixed) with another vaccine of the Nobivac® series, as indicated under “INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION”, the vaccines should be given subcutaneously at the same time, at a different site. Dogs should not be younger than the minimum age recommended for the other Nobivac® vaccines, as stated in their respective product information leaflets.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Safety and efficacy data are available which demonstrate that Nobivac® Respira Bb vaccine can be administered at the same time, but not mixed, with Nobivac® DHPPi, Nobivac® L6 and Nobivac® Rabies.

When Nobivac® Respira Bb is administered in association with the relevant Nobivac® vaccines, the demonstrated safety and efficacy claims of Nobivac® Respira Bb are the same as when this vaccine is administered alone.

The product information of the relevant Nobivac® vaccines used in association with Nobivac® Respira Bb should be consulted with the assistance of a veterinarian before administration.

No information is available on the safety and efficacy of Nobivac® Respira Bb when used with any other veterinary medicinal products except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.

SIDE EFFECTS

A transient swelling at the site of injection (≤ 2 cm), which can occasionally be firm, may commonly be present for up to 25 days post-vaccination. A medium size transient swelling at the site of injection (≤ 3,5 cm) may occur in common cases and can be painful. The swelling may uncommonly last for up to 35 days post-vaccination.

PRESENTATION

An aqueous, white to nearly white suspension presented in a polyethylene terephthalate (PET) multi-dose vial closed with a halogenobutyl rubber stopper and aluminium cap, containing 10 mℓ (10 doses) of vaccine.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0)11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT 21 July 2022