Rotavec Corona Data Sheet

Inactivated vaccine containing per dose of 2 ml:

Bovine rotavirus, strain UK-Compton, serotype G6 P5 (inactivated)1/4 dose of vaccine stimulates a virus neutralising antibody titre: ≥ 7.7 log2/ml (guinea pigs).
Bovine coronavirus, strain Mebus (inactivated)1/20 dose of vaccine stimulates an ELISA antibody titre: ≥ 3.41 log10/ml (guinea pigs).
E. coli F5 (K99) adhesin1/20 dose of vaccine stimulates an ELISA antibody (OD492):> 0.64 (guinea pigs).

Also contains 1.5 ml Light Mineral Oil / emulsifier and 2.45 – 3.32 mg Aluminium hydroxide as adjuvants and 0.051 – 0.069 mg Thiomersal as preservative.

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.
The vaccine is intended to stimulate active immunity in order to provide passive immunity to the progeny against active substances. Passive protection against all active substances will commence from the start of colostrum feeding. In calves artificially fed with pooled colostrum, protection will continue until colostrum feeding ceases.

Dosage and administration
Can be used during pregnancy.
Dose - 2 ml.

By intramuscular injection. The recommended site is the side of the neck.
The bottle should be well shaken before any vaccine is withdrawn.
A single injection should be given during each pregnancy between 12 and 3 weeks before calving is expected.
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.

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.
Contra-indications, warnings, etc
Particularly strict precautions should be taken against contamination of the vaccine.
Do not vaccinate unhealthy animals.

Adverse reactions
Occasionally a soft swelling raised up to 1 cm may be observed at the site of injection, which will resorb within 14 to 21 days.
Occasional hypersensitivity reactions may occur. In such cases appropriate treatment such as adrenaline should be administered without delay.
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.

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 other veterinary medicinal product.

Operator warnings
To the user:
This 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 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.

Withdrawal periods
Zero days.
For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions
Store and transport refrigerated (2 °C – 8 °C). Protect from light. Do not freeze.
In use shelf life: 8 hours.
Disposal advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

Packaging Quantities
Carton with one bottle containing 10 ml (5 doses) or one bottle containing 40 ml (20 doses).

Further information
The feeding of pooled colostrum is recognised as a potential factor in the spread of Johne’s disease. Please discuss this with your veterinary surgeon(s) if you are concerned.

Marketing authorisation number
Vm 01708/4556

Intervet/Schering-Plough Animal Health
Milton Keynes, Bucks.

Date of text preparation:
August 2010.