Bronchi-Shield, Lyophilisate And Solvent For Suspension For Nasal Drops For Dogs
Revised: September 2016
NAME OF THE VETERINARY MEDICINAL PRODUCT
BRONCHI-SHIELD, lyophilisate and solvent for suspension for nasal drops for dogs.
Duramune Bb vet (NO and SE)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1 ml) of vaccine contains:
1. Lyophilized fraction:
Bordetella bronchiseptica, live, strain 92B 2.1 x 106to 5.5 x 108CFU (*)
(*) CFU: colony forming unit
For a full list of excipients, see section 6.1.
Water for injections 1 ml
Lyophilisate and solvent for suspension for nasal drops.
Uniform cream colour freeze-dried powder.
Indications for use, specifying the target species
For active immunization of dogs of 8 weeks of age or older to reduce coughing caused by Bordetella bronchiseptica.
Duration of immunity: 1 year.
Onset of immunity: from 5 days after vaccination.
Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
See section 4.6.
Special warnings for each target species
The product contains live bacteria and must be administered by the intranasal route only. Parenteral administration can generate abscesses and cellulitis.
If any antibiotic is used within 2 weeks after vaccination, vaccination should be repeated after completion of the antibiotic treatment.
Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Vaccinated dogs may excrete the vaccine strain of Bordetella bronchisepticaup to 7 weeks following vaccination. During this time, immunodepressed persons are advised to avoid contact with vaccinated dogs. Similar precautions are also applicable to unvaccinated in-contact or immunodepressed animals.
The vaccine has been shown safe in pigs. Cats and unvaccinated dogs in contact with vaccinated dogs may react to the vaccine strain, presenting moderate clinical signs such as sneezing, nasal and ocular discharge. Other animals, such as rabbits and small rodents, have not been tested.
Special precautions should be taken to avoid spreading of the vaccine strain in the clinic.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Disinfect hands and equipment after use.
In case of accidental self-injection during reconstitution of the product or inhalation of the aerosolized product at the time of application in the dog nostrils, seek medical advice immediately and show the package leaflet or the label to the physician.
Persons administering the product to the dog should be aware that repeated exposure to the product by inhalation of aerosolized product may lead to rare hypersensitivity reactions.
Although the risk that immunocompromised humans become infected with Bordetella bronchisepticais extremely low, such individuals should be aware that dogs can shed the organism for up to 7 weeks after vaccination. Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated dogs during the shedding period.
Adverse reactions (frequency and seriousness)
in rare cases, transient coughing (1 or 2 days) may occur during the first days following vaccination.
In rare cases, transient nasal or ocular discharge may be observed.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated. However, veterinarians should be aware that antibiotic treatment given less than 14 days after vaccination may impair vaccine efficacy.
Hypersensitivity reactions may occur in very rare cases. In case of anaphylactic reaction, administer adrenaline.
The frequency of adverse reactions is defined using the following convention :
very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
The use is not recommended during pregnancy and lactation due to the lack of supportive studies and possible spread of the vaccine strain.
Interaction with other medicinal products and other forms of interaction
Do not use immunodepressing agents within 1 month of vaccination with the product.
Do not administer antibiotics during 14 days following vaccination.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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
The vaccine is to be administered by nasal drops to dogs of the age of 8 weeks and older.
Aseptically reconstitute the lyophilisate with the solvent.
Shake the product well after reconstitution. Withdraw the liquid with the syringe, remove the needle and replace with the applicator. The vaccine should be used immediately.
The head of the dog should be held with the nose pointing upwards and its mouth closed, so that it is forced to breath through its nostrils. Administer the product in the nostrils drop by drop.
Vaccination with 1 dose of 1 ml per dog from the age of 8 weeks.
Administer 0.5 ml of the vaccine in each nostril. For larger animals (>15 kg), 1 ml may be administered in a single nostril.
One dose at least five days before the period of anticipated risk, e.g. temporary kennelling.
See also section 4.5 “Special precautions for use”.
Annual booster of one dose.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In addition to the adverse reactions mentioned in section 4.6, ten-fold overdose vaccinated puppies may sneeze one or more times following vaccination.
Pharmacotherapeutic group: immunologicals fpr canidae live bacterial vaccines for dogs
ATC-vet code: QI07AE01
Live vaccine stimulating active immunity against Bordetella bronchiseptica in dogs.
List of excipients
Potassium dihydrogen phosphate
Eagle HEPES medium
Hydrochloric acid for pH adjustment
Sodium hydroxide for pH adjustment
Water for injections
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after reconstitution according to directions: Use immediately.
Special precautions for storage
Store and transport refrigerated (+2°C – +8C) and protect from light.
Do not freeze.
Nature and composition of immediate packaging
Vial: Type I glass vial
Closure: Bromobutyl rubber stopper sealed with aluminum cap
Vial: Type I glass vial
Closure: Chlorobutyl stopper sealed with aluminum cap
Box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 dose of solvent and 10 cannulae for application
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
MARKETING AUTHOrisation NUMBER
DATE OF FIRST AUTHORISATION
18 July 2005
DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
Subject to prescription.
The import, sale, supply and/or use of Bronchi-Shield is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Bronchi-Shield must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
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