Nobivac Respira Bb injectable vaccine

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BORDETELLA BRONCHISEPTICA FIMBRIAE; THIOMERSAL; DL-ALPHA-TOCOPHERYL ACETATE

Available from:

INTERVET AUSTRALIA PTY LIMITED

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

BORDETELLA BRONCHISEPTICA FIMBRIAE VACCINE Active 88.0 units/ml; THIOMERSAL MERCURY Other 0.15 mg/ml; DL-ALPHA-TOCOPHERYL ACETATE VITAMIN E Other 74.7 mg/ml

Units in package:

1 x 10 doses (10 mL multidose vial); 10 x 1 dose (1 mL pre-filled syringe); 5 x 1 dose (1 mL pre-filled syringe)

Class:

VM - Veterinary Medicine

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: N/A N/A; Host/pest details: DOG - OVER 6 WEEKS OLD: [BORDETELLA BRONCHISEPTICA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Nobivac Respira Bb injectable vaccine
91275/131572
Product Name:
APVMA Approval No:
Label Name:
Nobivac Respira Bb injectable vaccine
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Purified inactivated Bordetella bronchiseptica fimbriae: ≥ 88 U/mL
Also contains:
74.7 mg/mL dl-α-tocopheryl acetate (adjuvant)
[multidose vials only]
0.15 mg/mL thiomersal (preservative)
Claims:
For active immunisation of dogs against Bordetella bronchiseptica to
reduce clinical signs
of upper respiratory tract disease.
Onset of immunity: 2 weeks.
Duration of immunity: 7 months after primary vaccination. 1 year after
re-vaccination.
Net Contents:
[Pre-filled syringe]
5 x 1 mL dose
10 x 1 mL dose
[Multidose vials]
1 x 10 doses (10 mL)
Directions for Use:
Restraints:
Contraindications:
Precautions:
This vaccine can be used during pregnancy. However, the safety of this
vaccine has not
been investigated during the first 20 days of gestation.
The safety of this vaccine in breeding males has not been
investigated. RLP APPROVED
Side Effects:
A transient swelling at the site of injection (≤ 2 cm), which can
occasionally be firm, may
very 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.
Dosage and
Administration:
[Multidose vial only]
Shake well before each administered dose. Avoid introduction of
contamination by using a
clean needle for each administered dose.
Use the contents within 28 days of first broaching the vial. Discard
the unused portion.
[All presentations]
Do not mix with any other veterinary medicinal product. Allow the
vaccine to reach room
temperature (15°C - 25°C) before use.
Subcutaneous use, 1 mL dose per vaccination.
Dogs can be vaccinated from the age of 6 weeks onwards.
Vaccinate healthy animals only.
Primary vaccination:
Two vaccinations with an interval of 4 weeks.
Re-vaccination:
A single vaccination, a