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Date: Wednesday, May 22, 2024 19:50

Release 6.52
Bronchi-Shield® lyophilisate and solvent for suspension for nasal drops for dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Bronchi-Shield® lyophilisate and solvent for suspension for nasal drops for dogs
Product index: Bronchi-Shield
Incorporating:
Presentation
Bronchi-Shield is a combination vaccine presented as a lyophilisate and solvent for suspension for nasal drops.
Each dose comprises:
One vial of lyophilised fraction containing live attenuated Bordetella bronchiseptica, strain 92B: 2.1 x 106 to 5.5 x 108 CFU* per dose; and one vial of sterilised water for injections (Ph.Eur.)
(*) CFU: colony forming unit
Uses
For active immunisation 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.
Dosage and administration
The vaccine is to be administered by nasal drops to dogs of the age 8 weeks and older.
Primary vaccination
Vaccination with 1 dose of 1ml per dog from the age of 8 weeks. Administer 0.5ml of vaccine in each nostril. For larger animals (>15 kg), 1.0ml may be administered in a single nostril.
One dose at least five days before the period of anticipated risk, e.g. temporary kennelling.
Booster
Annual booster of one dose.
Advice on correct administration
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 breathe through its nostrils. Administer the product in the nostrils drop by drop.
Contra-indications, warnings, etc
For animal treatment only
Vaccinate healthy animals only.
The use is not recommended during pregnancy and lactation due to the lack of supportive studies and possible spread of the vaccine strain.
Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
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 reactions, 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).
In addition to the adverse reactions mentioned above, ten-fold overdose vaccinated puppies may sneeze one or more times following vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
The product contains live bacteria and must be administered by the intranasal route only. Parenteral administration can generate abscesses and cellulitis. Do not use immunodepressing agents within 1 month of vaccination with the product. Do not administer antibiotics during 14 days following vaccination. If any antibiotic is used within 2 weeks after vaccination, vaccination should be repeated after competition of the antibiotic treatment.
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.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Special precautions for use in animals
Vaccinated dogs may excrete the vaccine strain of Bordetella bronchiseptica up 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.
Operator warnings
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 bronchiseptica is 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.
Pharmaceutical precautions
Store and transport refrigerated (+2°C to +8°C). Protect from light. Do not freeze.
Keep out of the sight and reach of children.
Do not use after the expiration date shown on the vial labels.
Shelf-life after reconstitution according to directions: Use immediately
Legal category
Legal category: POM-V
Packaging quantities
Packs with 10 x 1 ml doses. Each dose is a combination of one vial of the lyophilised fraction, one vial of solvent fraction and one cannula for application.
Further information
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 Number
Vm 42058/4011
Significant changes
GTIN
GTIN description:10 x 1 dose:
GTIN:05414736024561