SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Lactovac or Lactovac C or Bovilis Lactovac C

Suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml dose contains the following:

Active Substances

Inactivated bovine rotavirus, strain 1005/78 at least 10^7.4TCID₅₀*, inducing >1 RPU***

Inactivated bovine rotavirus, strain Holland at least 10^7.0TCID₅₀, inducing >1 RPU

Inactivated bovine coronavirus, strain 800 at least 10^5.8TCID₅₀, inducing >1 RPU

Inactivated E.coliK99/F41 250 HAU**, inducing >1 RPU

Adjuvants

Aluminium hydroxide 60 mg

Saponin / Quil A 1 mg

Excipients

Thiomersal 0.05 mg

For a full list of excipients, see section 6.1.

* Tissue culture infective dose

** Haemagglutinating units

*** 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.

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (cows and heifers during advanced pregnancy).

4.2 Indications for use, specifying the target species

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.coliinfections.

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

4.3 Contraindications

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

4.4 Special warnings for each target species

Protection of the herd.

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.

Herd hygiene

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

Immune protection

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.

4.5 Special precautions for use

Only vaccinate immuno-competent animals.

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 product with caution.

4.6 Adverse reactions (frequency and seriousness)

Immunisation may rarely result in temporary swellings at the injection site (ranging from small nodules of approximately 1cm in diameter to swellings of 20 cm 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 non-significant level within one day may be expected.

4.7 Use during pregnancy and lactation

The vaccine can be used during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

Immunising dose:

5ml

Method of administration:

Subcutaneous injection into the side of the neck.

Basic immunisation:

All cows in a herd should receive two injections of 5ml 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.

Booster injection:

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

Passive immunisation of the calves:

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.

Feeding and storage of colostrum

For optimal protection it has been shown that the 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 should be pooled, aliquoted and stored deep frozen (-20 ^o C for maximal one year). Alternatively, these colostrum pools can be stored at about +4^oC 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 500 ml of pooled colostrum each day.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Accidental overdosage is unlikely to cause any reaction other than those described in section 4.6.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity in pregnant cows and heifers in order to provide passive immunity through the colostrum and milk to the progeny against rotaviruses, coronavirus and E.coli, i.e. against the principal pathogens of newborn calf diarrhoea. ATCvet code: QI02AL01

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Thiomersal

Water for injection.

6.2 Incompatibilities

Do not mix with any other vaccine/immunological product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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

6.4 Special precautions for storage

Store in a refrigerator (2 ºC – 8 ºC). Protect from frost.

6.5 Nature and composition of immediate packaging

Cardboard box containing one type I glass vial of 25 ml with type I rubber stoppers sealed with an aluminium crimp cap.

Cardboard box containing 10 type I glass vials of 5 ml with type I rubber stoppers sealed with an aluminium crimp cap.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4075

9. DATE OF FIRST AUTHORISATION

Date:26 August 1998

10 DATE OF REVISION OF THE TEXT

Date:October 2013

05 November 2013