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BRONCHI-SHIELD, Lyophilisate and solvent for suspension for nasal drops for dogs

Description

Each dose comprises:
Freeze-dried fraction (Lyophilisate)

Active Substances:
Bordetella bronchiseptica, live, strain 92B
(*) CFU : colony forming unit
2.1 x 106 to 5.5 x 108 CFU(*)
Solvent:
Water for injectionsad 1 ml

INDICATIONS

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

CONTRAINDICATIONS

Do not vaccinate sick/unhealthy animals.
Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.

ADVERSE REACTIONS

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 reaction, administer adrenaline.

TARGET SPECIES

Dogs.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

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.
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), 1.0 ml 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

Disinfect hands and equipment after use.

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Shelf life after reconstitution according to directions: 8 hours.

SPECIAL STORAGE PRECAUTIONS

Store and transport refrigerated (+2°C to +8°C).
Do not freeze.
Protect from light.

SPECIAL WARNINGS

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 in animals

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not use during pregnancy and lactation, due to the lack of supportive studies and possible spread of the vaccine strain.
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.
Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

OTHER INFORMATION

ATCv Code: QI07AE01
Nature and composition of immediate packaging
Freeze-dried Fraction:
Vial : Type I glass vial
Closure : Bromobutyl rubber stopper sealed with aluminum cap
Solvent
Vial : Type I glass vial
Closure : Bromobutyl stopper sealed with aluminum cap
Presentations
Box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 dose of solvent and 10 cannulae for application

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