A suspension for injection, each 5 ml contains:

Each dose also contains aluminium hydroxide (60 mg) and Quil A (Quillaja saponaria, saponin extract) (1 mg) as adjuvants and thiomersal (0.05 mg) as preservative.

* Relative potency unit; 1 RPU = antibody response in rabbit potency test not significantly lower than that obtained with a reference batch shown efficacious in cattle.

For the active immunisation of pregnant cows and heifers in order to confer passive protection to their calves (via colostrum) to reduce the severity and duration of neonatal diarrhoea caused by rotavirus, coronavirus and E. coli (K99/F41) infections.

Protection is conferred only while the calves are fed colostrum from vaccinated cows.

One dose of 5 ml by subcutaneous injection in the side of the neck, observing aseptic precautions.

All cows in a herd should receive two injections of 5 ml during the later stages of pregnancy, with an interval of 4-5 weeks between doses and allowing 2-3 weeks from the time of the second dose until the predicted date of calving.

During each subsequent pregnancy previously vaccinated cows should receive a single injection of 5 ml 2-6 weeks prior to predicted calving date.

In order to attain local passive immunisation within the intestine against neonatal diarrhoea, the newborn calves must receive sufficient quality colostrum and milk from the vaccinated dams during the first 10 to 14 days of life. For calves born to beef cows this can be achieved by allowing the calf to suckle naturally. Calves born to dairy cows often do not receive sufficient colostrum if suckled naturally, so artificial feeding of colostrum (e.g. via oesophageal tube feeders) should be used.

For optimal protection it has been shown that daily intake of colostrum is essential to the calf from birth to 2 weeks of age. All calves should be fed colostrum derived from the first milking, ideally within the first 6 hours of life. Calves should then either be left to suckle naturally for a minimum of 2 weeks or a colostrum feeding regime must be established. Any remaining quantities from the first milking and all the colostrum from the second milking of each individual dam should be pooled, aliquoted and stored deep frozen (-20ºC for a maximum of one year). Alternatively, these colostrum pools can be stored at about +4°C for about 2 weeks. Following the first suckling of colostrum from the dam by the calves, where the calves are separated from the dam, their feed must be supplemented with 500ml of pooled colostrum from their own dam each day.

Do not use in animals which have intercurrent infection or are in poor nutritional status.

Immunisation may very commonly result in temporary swellings at the injection site (ranging from small nodules of approximately 1 cm in diameter to swellings of 20 cm in diameter in extreme cases). Typically, these swellings completely disappear or reduce to a negligible size within 2-4 weeks after vaccination, though in individual animals very small reactions remain longer. Additionally, a transient slight rise in body temperature normally decreasing to a non-significant level within one day may commonly be expected.

The frequency of adverse reactions is defined using the following convention:

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.

Do not mix with any other veterinary medicinal product.

Zero days

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to any of the components of the product should administer the veterinary medicinal product with caution.

Store in a refrigerator (+2°C to +8°C). Protect from frost.

Shelf-life after first opening the immediate package: 10 hours.

Keep out of the sight and reach of children.

For animal treatment only.

Cardboard box containing a 25 ml glass vial of 5 doses or 10 x 5 ml single dose glass vials. Not all pack sizes may be marketed.

Neonatal diarrhoea in calves is caused by pathogens which are constantly present in the herd. For this reason proper control measures require that all pregnant cows and heifers in a herd must be included in the programme of immunisation. This is the only way in which the pressure of infection can be reduced.

Neonatal diarrhoea in calves is often associated with poor hygiene. Thus, general improvements in hygiene are important to support the effect of vaccination.

Diarrhoeal diseases can have many causes. The vaccine induces high levels of antibody in the colostrum and milk against rotavirus and coronavirus as well as against E. coli, i.e. against the principal pathogens of neonatal diarrhoea in calves.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Vm 42058/4075