Rispoval IBR-Marker Inactivated 100ml

CLINICAL PARTICULARS 4.1 Target species Cattle 4.2 Indications for use, specifying the target species For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce the clinical signs and virus shedding and, in female cattle, to prevent abortions associated with BoHV-1 infection. The vaccination of pregnant cattle will prevent abortion associated with BoHV-1 infections as demonstrated during the second trimester of gestation upon challenge 28 days after vaccination. Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless the cattle were previously vaccinated with a conventional vaccine or infected with field virus. Duration of immunity: 6 months - For booster immunisation after primovaccination with Rispoval IBR-Marker Vivum (in member states where this product is authorized) to reduce the virus shedding and the clinical signs associated with BoHV-1 infection in cattle and, in female cattle, to prevent abortions associated with BoHV-1 infection. This vaccination of cattle will prevent abortion associated with BoHV-1 infections as demonstrated during the third trimester of gestation upon challenge 86 days after the booster vaccination. Duration of immunity: 6 months after complete primovaccination with Rispoval IBR-Marker Vivum followed by 12 month after annual booster with Rispoval IBR-Marker Inactivatum. In order to prevent abortion in female cattle that have received basic immunisation, a single dose revaccination with Rispoval IBR-Marker Inactivatum is recommended to be applied no later than by the start of the second trimester of each further pregnancy. 4.3 Contraindications Do not use in unhealthy animals. 4.4 Special warnings None. 4.5 Special precautions for use Special precautions for use in animals None. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) Transient subcutaneous swelling up to 5 cm in diameter, which subsides within 14 days, may occur at the injection site in very rare cases. In very rare cases allergic reactions may occur as with other vaccines, therefore vaccinates should be observed for approximately 30 minutes following immunisation. In those cases, antiallergics should be administered. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 4.7 Use during pregnancy, lactation or lay Can be used during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction Immunosuppressive substances, i.e. corticosteroids or Bovine Virus Diarrhoea modified live vaccines, should be avoided in a period of 7 days prior to and after vaccination as this may impair the development of the immunity. 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 decided on a case by case basis.