Company
Nobivac Myxo Data Sheet
Lyophilisate and solvent for suspension for injection for rabbits.Presentation
Live vaccine containing >103.0 and <104.9 pfu of Shope fibroma virus per dose of 1 ml reconstituted product.
Uses
As an aid in the prevention of myxomatosis in rabbits.
Onset of immunity: The onset of immunity was established as two weeks after vaccination.
Duration of immunity: The duration of immunity was established as 6 months.
Dosage and administration
Transfer the contents of one vial of the solvent supplied (Nobivac® Solvent) into the vaccine vial by syringe and agitate until the lyophilisate is fully dissolved.
The vaccine should be reconstituted immediately before use with the solvent supplied.
Reconstituted Nobivac Myxo should be used immediately and should not be stored.
The contents of one vial of reconstituted vaccine should be injected into rabbits of 6 weeks of age or older. The nature of the virus is such that, in order to achieve best protection, 0.1 ml of each dose of the reconstituted vaccine should be administered by intradermal injection.
The intradermal injection is best administered in the relatively thick skin on the dorsal aspect at the base of the ear, using a 25g x 5/8″ needle and may be achieved by partial needle withdrawal following the subcutaneous injection. Alternatively, the subcutaneous injection can be given at a more commonly used site e.g. in the scruff of the neck.
Sterile equipment should be used for administration. Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectants or spirit to disinfect the skin prior to inoculation.
In the present state of knowledge no firm recommendation for revaccination frequency can be made but it is suggested that animals should be revaccinated annually in May/June just prior to the myxomatosis season as most myxomatosis in Britain occurs in late summer, autumn and early winter months. Where there is high risk of myxomatosis infection revaccination every six months is suggested.
Contra-indications, warnings, etc.
Do not vaccinate unhealthy animals.
The vaccine may not be effective in rabbits incubating the disease at the time of vaccination. Some animals may be immunologically incompetent and fail to respond to vaccination.
Do not use in animals intended for human consumption.
Following vaccination a small (<3.5 mm) circumscribed and transient swelling may develop at the site of injection approximately 1 week post vaccination and disappear by approximately 25 days.
In the rare event of a hypersensitivity reaction following vaccination administer adrenalin without delay and by the most immediate route.
Following an overdose a transient swelling (<6.5 mm) as observed following a single dose vaccination may develop at the site of injection approximately 1 week post vaccination.
If a rabbit with a degree of immunity is heavily challenged with myxomatosis, then atypical myxomatosis (‘lumpy bunny syndrome’) may be observed. In these instances, the rabbits do not develop typical clinical signs of myxomatosis, only the dermal lesions (hence ‘lumpy bunny syndrome’). Prognosis for recovery from atypical myxomatosis is good, although may be protracted, providing concomitant problems such as stress, pasteurellosis, etc., do not interfere.
The vaccine virus may spread to susceptible in-contact rabbits.
Do not use in breeding or pregnant animals.
No information is available on the safety and efficacy of the concurrent use of Nobivac Myxo with any other vaccine. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with Nobivac Myxo.
Do not mix with any other product except the solvent supplied for use with the vaccine.
Operator warning:
Particular care should be taken to avoid self-injection when administering intradermal inoculations.
Withdrawal period:
Not applicable.
FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Pharmaceutical precautions
Store between +2°C and +8°C. Protect from light.
Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use – in hot summer conditions vaccine potency can be severely reduced within a few hours.
Reconstituted vials should be used immediately.
Disposal advice:
Dispose of waste material by boiling, incineration or immersion in appropriate disinfectant in accordance with national requirements.
Legal category
POM-V To be supplied only on veterinary prescription.
Package quantities
Clear, glass Type I (Ph.Eur.) single dose vials with a halogenobutyl rubber stopper, closed with a coded aluminium cap. Packed in cartons of 5 single dose vials of vaccine plus 5 vials of solvent (Nobivac Solvent, Vm 01708/4368).
Further information
Nil.
Marketing Authorisation number
Vm 01708/4369 UK authorised veterinary medicinal product.
Marketing Authorisation holder
Intervet UK Ltd
Walton Manor
Walton
Milton Keynes,
Bucks MK7 7AJ
Distributed in Northern Ireland by:
Intervet Ireland Ltd.
Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Date of text preparation
26/07/06