Target species
Cattle.
Indications for use
For the active immunisation of cattle against:
- Parainfluenza-3 virus, to reduce infection,
- Respiratory Syncytial virus, to reduce infection and clinical signs,
- Mannheimia haemolytica serotype A1, to reduce infection, mortality, clinical signs, lung lesions and bacterial invasion of the lung caused by serotypes A1 and A6.
Cross-reactive immunity to the A6 serotype of Mannheimia haemolytica has been demonstrated in a challenge experiment under laboratory conditions after primary course of vaccination.
Approximately two weeks after completion of the basic immunisation programme, the humoral immune response against Bovine Respiratory Syncytial virus and Parainfluenza-3 virus is at its highest level. The duration of protective immunity has not been established in challenge experiments.
Onset of immunity: 2 weeks.
Duration of immunity: has not been established.
Contraindications
Do not vaccinate animals that have intercurrent disease, heavy parasitic infestation or are in poor general condition, since a satisfactory immune response will only be obtained in healthy and immuno-competent animals.
Special warnings for each target species
Vaccinate healthy animals only.
The basic immunisation should be started in time, so that immunity has fully developed by the beginning of the period of risk. The basic immunisation of calves should be completed prior to housing or should be performed in the housing unit under quarantine.
It is advisable to vaccinate all animals in a herd in order to minimise the infectious potential unless there is a contraindication. Failure to vaccinate individual animals may promote the transmission of pathogens and development of disease.
The magnitude of the antibody response may be reduced by maternally derived antibodies in calves up to six weeks of age. However, according to the results of challenge experiments, significant protection against infection by Bovine Respiratory Syncytial virus is still provided three weeks after the basic vaccination course, and significant protection against Parainfluenza-3 virus and Mannheimia haemolytica serotype A1 is still provided six weeks after the basic vaccination course. The results of challenge experiments in calves with maternally derived antibodies further indicate that the onset of cross-protective immunity to the A6 serotype is 2 weeks after completion of the vaccination course. Cross protective immunity is provided up to six weeks after the basic vaccination course as demonstrated by serological tests.
Respiratory infections in calves are often associated with poor hygiene. Thus, general improvements in hygiene are important to support the effect of vaccination.
Special precautions for use
Not applicable.
Operator Warning
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
In laboratory and field trials:
Common (1 to 10 animals / 100 animals treated): | Injection site swelling1. Elevated temperature2, reluctant to move. |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction3. |
1 In extreme cases narrow swellings up to 10 cm long. Typically, these swellings completely disappear or reduce in size to a negligible small lump within 2 to 3 weeks after vaccination, though in individual animals very small reactions can be found for up to 3 months.
2 Slight and lasting a maximum of 3 days after vaccination.
3 May be fatal.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Bovilis IBR Marker Live (where this product is authorised) in cattle from 3 weeks of age onwards.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.
Immunosuppressive drugs should generally not be used directly before or after vaccination, since a satisfactory immune response will only be obtained in immuno-competent animals.
Amounts to be administered and administration route
Method of administration:
Subcutaneous use. Injection into the side of the neck.
Dose:
5 ml.
Basic immunisation:
Animals from approximately 2 weeks of age should receive two vaccinations separated by an interval of approximately 4 weeks.
Booster doses: If booster doses are required, a single dose should be given approximately 2 weeks before each risk period (e.g. transport, introduction into a herd, change of housing).
The vaccine must be shaken well before use.
For vaccine administration, needles of 1.5 to 2.0 mm diameter and 10 to 18 mm long are recommended. The vaccine should be brought to room temperature prior to use and injected quickly.
Overdose
Accidental overdosage is unlikely to cause any reaction other than described in section "Adverse reactions", however the swelling may be larger and temperature rise may be higher.
Withdrawal period
Zero days.