Target species
Sheep.
Indications for use
For the active immunisation of sheep as an aid to the prevention of footrot and reduction of lesions of footrot caused by serogroups and/or serotypes of Dichelobacter nodosus.
Contraindications
Do not vaccinate sheep within 6 - 8 weeks of shearing.
Do not use in lactating dairy sheep.
Do not vaccinate ewes in the period of 4 weeks before lambing to 4 weeks after lambing.
Special warnings for each target species
None.
Special precautions for use
Sheep destined for show or sale should not be vaccinated within the previous 6 months because of the occurrence of a well-defined, inactive lump at the site of injection.
Operator warnings
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the doctor:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions
Sheep:
Very common (>1 animal / 10 animals treated): | Injection site swelling.1 |
Rare (1 to 10 animals / 10,000 animals treated): | Lameness.2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction.3 |
1The vaccine may cause a reaction at the site of injection. This may range from a slight swelling to a well-defined lump of about 3 cm to 5 cm or even 8 cm diameter, from about 24 hours after injection to 8 days after injection. These swellings generally remain inactive and may resolve completely within 4-6 weeks, but frequently swellings persist for at least 10 weeks. Occasionally, these swellings may be large, painful and unsightly, with the formation of abscesses which may burst and discharge, particularly if any contaminating skin bacteria are introduced at the time of injection. Partial or complete resolution within 10 weeks of inoculation can be expected. Reactions to second doses develop more slowly but the formation of necrotic lesions is rare. Occasionally abscesses may be noted on macroscopic examination of injection sites. Subcutaneous necrosis and inflammation may be noted on microscopic examination of injection sites.
2Generalised and transitory lameness, which is thought to be due to a local immunological reaction, has been reported after vaccination, occurring within 24 hours of vaccination and normally persisting for no more than 48 hours.
3In such cases adrenalin or antihistamines should be administered without delay.
Use during pregnancy or lactation
Pregnancy:
Can be used during pregnancy.
Interactions
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 decided on a case by case basis.
Amounts to be administered and administration route
Administration: Subcutaneous use.
Dose: 1 ml.
Primary vaccination: Two vaccinations, at an interval of 6 weeks. This vaccine should be administered by subcutaneous injection underneath a skinfold in the neck at least 5 – 8 cm behind the ear to strictly avoid muscle and nervous tissues in the neck.
Shake bottle thoroughly before use.
As the vaccine contains an oil adjuvant it is rather viscous. It will aid administration in cold weather if the vaccine is gently warmed by immersion in warm water (not hot) for 3-4 minutes before use.
Particularly strict precautions should be taken against contamination of the vaccine.
Sterile syringes and needles should be used and the injection made through an area
of clean, dry skin, taking strict precautions against contamination in order to reduce the possibility of abscess formation.
Vaccination programmes:
These should be tailored to meet individual flock requirements which will vary from season to season according to the actual or likely incidence of footrot.
Wherever possible ‘whole flock’ vaccination programmes should be adopted. By this means disease incidence in the flock will decline and subsequent disease risk from the environment will be greatly reduced.
Prevention programme:
Commence vaccination with a single dose of vaccine. Further doses of vaccine will be required according to the flock disease status and/or the climatic conditions. If, after 4-6 weeks significant levels of disease remain in the flock or climatic conditions conducive to footrot persist, administer a further dose. Otherwise delay this dose until conditions favour re-emergence of the disease.
Subsequent doses should also be administered according to prevailing conditions. Thus, with severe and constant disease challenge, revaccination may be necessary at 4-5 monthly intervals; conversely under favourable conditions revaccination may be delayed until the incidence of disease challenge increases or climatic conditions worsen.
It should be noted that these adverse conditions tend to occur in the UK between March and May and between October and December thus, vaccination should normally be completed shortly before these periods if problems are anticipated.
Treatment programme:
A single dose of vaccine should be given to the flock immediately the disease becomes apparent. For maximum effect, treatment with the vaccine should be combined with the use of a footbath and antibiotic treatment.
Revaccination should be as stated in the prevention programme, which should then be continued on the farm as the key element of the overall flock foot care programme.
Overdose
At a 2-fold overdose, no other effects other than those described in section "Adverse reactions" have been observed.
Withdrawal periods
Zero days.