Versican Plus Bb Oral Suspension for dogs (pack of 10 x 1 dose)

Uses
Active immunisation of dogs from 8 weeks of age:
•to reduce clinical signs and excretion following infection with Bordetella bronchiseptica.
Onset of immunity
3 weeks.
Duration of immunity
12 months.
Dosage and administration
Method and route of administration
1Grip the lyophilisate vial with your fingers and position your thumb directly under the embossed triangle on the vial cap.
2Using your thumb, push the vial cap upwards from underneath the embossed triangle to allow access to the rubber stopper. Do not remove the vial cap or aluminium collar as they are not designed to be removed for use with a syringe and needle. Aseptically reconstitute the lyophilisate with the solvent. The reconstituted product should be an orange to yellow coloured liquid. Shake the product well after reconstitution. Withdraw the liquid with the syringe and remove the needle. The vaccine should then be used immediately.
3The head of the dog should be held with the nose pointing upwards and mouth open. Administer the entire 1 ml dose into the buccal pouch (between the teeth and the buccal mucosa).
Administration Instructions: Versican Plus Bb Oral Lyophilisate & Solvent for Oral Suspension for Dogs
Description: Figure 1
Description: Figure 2
Description: Figure 3
Primary vaccination scheme
Vaccination with 1 dose of 1 ml per dog from the age of 8 weeks.
Re-vaccination scheme
One dose annually.
Contra-indications, warnings, etc
Vaccinate healthy animals only.
The product contains live bacteria and must be administered by the oral route only. Parenteral administration can generate abscesses and cellulitis.
Vaccinated dogs may shed the vaccine strain of Bordetella bronchiseptica for up to 35 days oronasally and for at least 70 days in faeces.
Due to the attenuated nature of the vaccine strain it is not necessary to keep unvaccinated dogs separate from vaccinated animals, however during this time it is advised that any immunocompromised dogs should avoid contact with vaccinated dogs.
The Bordetella bronchiseptica in the vaccine has been shown to be safe in pigs exposed to the vaccine strain (e.g. from contact with vaccinated dogs). Cats exposed to the vaccine strain (e.g. from contact with vaccinated dogs) may show moderate clinical signs such as sneezing, nasal and ocular discharge.
Safety of the bacteria in the vaccine shed by vaccinated dogs has not been studied in other animal species.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, use is not recommended in pregnant or lactating bitches.
Do not use immunosuppressive agents within 1 month of vaccination with the product.
Do not administer antibiotics for 14 days following vaccination.
The product has been shown safe when given at the same time as vaccines of the Versican Plus and Vanguard ranges containing live canine parvovirus, adenovirus, distemper virus, parainfluenza virus as well as inactivated Leptospira and rabies. Efficacy after concurrent use has not been tested.
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 veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Rarely a mild ocular discharge may occur after vaccination.
Very rarely mild transient diarrhoea, vomiting, nasal discharge, mild transient cough or lethargy can occur for up to 14 days after vaccination.
If an animal were to show more severe respiratory signs, appropriate treatment may be indicated.
Hypersensitivity reactions may occur in very rare cases. If such a reaction occurs, appropriate treatment should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals treated displaying adverse reaction(s))
-common (more than 1 but less than 10 animals in 100 animals treated)
-uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
-rare (more than 1 but less than 10 animals in 10,000 animals treated)
-very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
No adverse reactions other than those mentioned above were observed after administration of a 10-fold overdose of the vaccine.
User warnings
Disinfect hands and equipment after use.
In case of accidental self-injection during reconstitution of the product, 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 may lead to rare hypersensitivity reactions.
Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated dogs during the oronasal shedding period.
Pharmaceutical precautions
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.
Shelf life after reconstitution according to directions: use immediately.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category:POM-V
Packaging quantities
Packs with 10x 1 ml doses. Each dose is a combination of one vial of the lyophilisate fraction and one vial of solvent fraction.