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Clinical particulars
Target Species
Cattle (pregnant cows and heifers)
Indications for use
For the active immunisation of pregnant cows and heifers to raise antibodies against E. coli adhesin F5 (K99) antigen, rotavirus and coronavirus. While calves are fed colostrum from vaccinated cows during the first two to four weeks of life, these antibodies have been demonstrated to:
- reduce the severity of diarrhoea caused by E. coli F5 (K99)
- reduce the incidence of scours caused by rotavirus
- reduce the shedding of virus by calves infected with rotavirus or coronavirus.
Onset of Immunity : Passive protection against all active substances will commence from the start of colostrum feeding.
Duration of Immunity : In calves artificially fed with pooled colostrum, protection will continue until colostrum feeding ceases. In naturally suckled calves, protection against rotavirus will persist for at least 7 days and against coronavirus for at least 14 days.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Particularly strict precautions should be taken against contamination of the vaccine.
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 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 physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this 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
A soft swelling raised up to 1 cm was observed very commonly at the site of injection during safety and clinical studies. These swellings usually resorb within 14 to 21 days.
Hypersensitivity reactions were observed in spontaneous pharmacovigilance reports in very rare cases. In such cases, appropriate treatment such as adrenaline 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).
Use during pregnancy or lactation
Can be used during pregnancy.
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.
Amounts to be administered and administration route
Intramuscular use.
Shake well before use. Syringes and needles should be sterilised before use and the injection should be made through an area of clean, dry skin taking precautions against contamination.
Strict precautions should be taken against contamination of the vaccine. The use of a multi-dose syringe is recommended to avoid excessive broaching of the stopper. Once a vial is broached for the first time it may be used once more during the next 28 days and then discarded immediately after that use.
Administer a single dose of 2 ml per animal. The recommended site of injection is the side of the neck.
A single injection should be given during each pregnancy between 12 and 3 weeks before calving is expected.
Colostrum feeding:
Protection of calves depends on the physical presence of colostrum antibodies (from vaccinated cows) within the gut for the duration of the first 2 - 3 weeks of life until calves develop their own immunity. Thus it is essential to ensure adequate colostrum feeding for the whole of this period to maximise the efficacy of vaccination. All calves must receive adequate colostrum from their dams within 6 hours of birth. Suckled calves will continue to receive adequate colostrum naturally by feeding from vaccinated cows.
In the dairy herd colostrum/milk from the first 6 - 8 milkings of vaccinated cows should be pooled. The colostrum may be stored below 20 °C but should be used as soon as possible as immunoglobulin levels may fall by up to 50% after storage for 28 days. Where possible, storage at 4 °C is recommended. The calves should be fed on this pool at the rate of 2½ to 3½ litres per day (according to body size) for the first two weeks of life.
Optimal results will be obtained if a whole herd cow vaccination policy is adopted. This will ensure that in calves the level of infection and consequent virus excretion is kept to a minimum and consequently the overall level of disease challenge on the farm is minimised.
On administration of an intramuscular injection of not more than double the recommended dose, a reaction no more severe than after administration of a single dose may occur.
Withdrawal period
Zero days.