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Date: Tuesday, May 21, 2024 1:31

Description: MSD-AH
Release 2.145
Nobivac® Respira Bb suspension for injection for dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Nobivac® Respira Bb suspension for injection for dogs
Product index: Nobivac® Respira Bb suspension
Incorporating:
Qualitative and quantitative composition
Each dose of 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
Excipients:
Thiomersal: 0.15 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection. Aqueous, white to nearly white suspension, mild creaming
Clinical particulars
Target species
Dogs.
Indications for use
For active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection.
Onset of immunity: 2 weeks.
Duration of immunity: 7 months after primary vaccination. 1 year after revaccination.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
Not applicable.
Adverse reactions
Dogs:
Very common
(> 1 animal / 10 animals treated):
Injection site swelling (≤ 2 cm, occassionally firm, may be present up to 25 days post-vaccination).
Common
(1 to 10 animals / 100 animals treated):
Injection site swelling (≤ 3.5 cm, may be present up to 25 days post-vaccination1 and can be painful)
Very rare
(< 1 animal / 10,000 animals treated, including isolated reports):
Hypersensitivity reaction.2
1 The swelling may uncommonly last for up to 35 days post-vaccination.
2 If hypersensitivity reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition which may be life-threatening.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy or lactation
Pregnancy:
Can be used during pregnancy. The safety of this vaccine has not been investigated during the first 20 days of gestation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the live vaccines in the Nobivac range against canine distemper, canine contagious hepatitis caused by canine adenovirus type 1, canine parvovirus disease and respiratory disease caused by canine adenovirus type 2, where authorised.
Safety data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the Nobivac range of vaccines mentioned above together with the live Nobivac parainfluenza vaccine and the inactivated vaccines in the Nobivac range against leptospirosis caused by L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
In addition, for the live canine parainfluenza vaccine there are antibody response data, and for the inactivated canine leptospirosis vaccines there are antibody response data and other immunity data which support the use of the vaccine at the same time but not mixed with the mentioned Nobivac range of vaccines.
When this vaccine is administered in association with the relevant Nobivac vaccines, the demonstrated safety and efficacy claims of the vaccine are the same as when this vaccine is administered alone.
The product information of the relevant Nobivac vaccines used in association with this vaccine should be consulted before administration.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product 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.
Amounts to be administered and administration route
Subcutaneous use, 1 ml dose per vaccination.
Dogs can be vaccinated from the age of 6 weeks onwards.
Allow the vaccine to reach room temperature (15 °C – 25 °C) before use.
Primary vaccination: Two vaccinations with an interval of 4 weeks.
Revaccination: A single vaccination, administered 7 months after primary vaccination with this vaccine, is sufficient to maintain protection against Bordetella bronchiseptica for a further year. Thereafter, a single vaccination should be administered, annually. In case revaccination at 7 months is missed, a single vaccination within 12 months after primary vaccination is sufficient to extend protection against Bordetella bronchiseptica for a further year.
This vaccine can also be used for revaccination in a schedule where Nobivac KC has been used for primary vaccination. A single vaccination, administered one year after primary vaccination with Nobivac KC, is sufficient to prolong immunity against Bordetella bronchiseptica for another year.
Revaccination after primary vaccination with Nobivac KC: One vaccination, annually.
For associated use: When this vaccine is administered in associated use (i.e. not mixed) with another vaccine in the Nobivac range as indicated under section ‘Interactions’, 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 vaccine, as stated in the respective product information.
Overdose
Not applicable.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATC Vet Code: QI07AB03.
Pharmacotherapeutic group
Immunologicals for Canidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
The subunit vaccine stimulates active immunity against Bordetella bronchiseptica infection in dogs.
Pharmaceutical particulars
Excipients
dl-α-tocopheryl acetate
Thiomersal
Sodium chloride
Disodium hydrogen phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Polysorbate 80
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 4 weeks.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package in order to protect from light.
Once broached, store between 2 °C – 25 °C. Do not freeze.
Immediate packaging
Polyethylene terephthalate (PET) vial closed with a halogenobutyl rubber stopper and aluminium cap.
Pack size:
Cardboard box with 1 multidose vial containing 10 doses (10 ml) of vaccine.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5067
UK(NI): Vm 01708/3001
Significant changes
Date of the first authorisation or date of renewal
18 August 2020.
Date of revision of the text
March 2023.
Any other information
For animal treatment only.
Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
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