Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

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 intranasally to dogs 8 weeks of age or 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 breath through its nostrils. Administer the product in the nostrils drop by drop.

Contra-indications, warnings, etc

For Animal Treatment Only

Do not vaccinate sick animals/unhealthy animals.

Do not use in pregnant or lactating bitches.

Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.

Occasionally, transient coughing (1 or 2 days) may occur, during the first days following vaccination.

In rare occasions, 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 case of anaphylactic reactions, administer adrenaline.

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. No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product. Do not administer antibiotics during 14 days following vaccination. Do not mix with any other vaccine or immunological 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 reach and sight of children.

Do not use after the expiration date shown on the vial labels.

Shelf-life after reconstitution according to directions: 8 hours

Legal category

POM-V

Packaging Quantities

Packs with 5 or 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.

Not all pack sizes may be marketed.

Further information

Disposal:

Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Marketing authorisation number

Vm01596/4332.