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Clinical particulars
Target species
Cattle (cows and heifers).
Indications for use
For active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with bovine viral diarrhoea virus.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precaution for use
Not applicable.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
In very rare cases a slight swelling may be observed for 14 days at the site of injection. Also in very rare cases transient mild pyrexia may occur. In very rare cases, hypersensitivity reactions including anaphylactic shock may occur. In the event of anaphylactic type reactions, appropriate treatment such as with antihistamine, corticosteroid or adrenaline is recommended.
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.
Interactions
Safety and efficacy data are available which demonstrate that for re-vaccination -in cattle from 15 months of age onwards (i.e. those that have previously been vaccinated separately with Bovilis BVD and Bovilis IBR Marker Live) - this vaccine can be mixed and administered with Bovilis IBR Marker Live (in Member States where this veterinary medicinal product is authorised). The product literature of Bovilis IBR Marker Live should be consulted before administration of the mixed products. The adverse effects observed after administration of one dose or an overdose of the mixed vaccines are not different from those described for the vaccines administered separately.
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.
Amounts to be administered and administration route
Before using the vaccine allow it to reach ambient temperature (15 °C – 25 °C).
Shake well before use. Use sterile syringes and needles.
Intramuscular injection. 2 ml per animal.
All cattle can be vaccinated from an age of eight months onwards.
Foetal protection can be expected if the primary immunisation has been finalised 4 weeks before start of the gestation. Animals which are vaccinated later than 4 weeks before gestation or during the early gestation will not be protected against foetal infection.
Individual vaccination
Basic immunisation
Two vaccinations with an interval of 4 weeks. The second vaccination should be given not later than 4 weeks before the start of the gestation. Revaccination
One vaccination 4 weeks before start of the next gestation.
Herd vaccination
Basic immunisation
Two vaccinations with an interval of 4 weeks. For use in cattle from eight months of age, all animals should be vaccinated.
Revaccination
One vaccination 6 months after basic vaccination with next re-vaccinations at an interval no greater than 12 months.
For revaccination, the vaccine may be used for reconstitution of Bovilis IBR Marker Live for use in cattle from 15 months of age (i.e. those that have previously been vaccinated separately with Bovilis BVD and Bovilis IBR Marker Live) and the following instructions should be used:
Bovilis IBR Marker Live Bovilis BVD
5 doses + 10 ml
10 doses + 20 ml
25 doses + 50 ml
50 doses + 100 ml
A single dose (2 ml) of Bovilis BVD mixed with Bovilis IBR Marker Live is given intramuscularly.
Visual appearance after reconstitution of Bovilis IBR Marker Live in Bovilis BVD:
As specified for Bovilis BVD alone.
Overdose
Reactions after a double dose are not different from those after the single dose.
Withdrawal period
Zero days.