Rispoval Intranasal RS+PI3 5 Dose

Target Species Cattle 4.2 Indications for Use, Specifying the Target Species For active immunisation of maternally derived antibody positive or negative calves from 9 days of age against BRSV and PI3V, to reduce the mean titre and duration of excretion of both viruses. Onset of protective immunity: 5 days for BRSV and 10 days for PI3V after a single vaccination. Duration of protective immunity: 12 weeks following a single dose. The duration of protective immunity against the PI3V fraction may be reduced in MDA positive calves vaccinated before 3 weeks of age. 4.3 Contraindications None. 4.4 Special warnings for Cattle None. 4.5 Special precautions for use Special precautions for use in animals Vaccinate only healthy animals. Vaccinal viruses can spread from vaccinated to non-vaccinated calves and may cause a serological response, but without causing clinical signs. In laboratory experiments based on the data using 3 week-old animals, shedding was observed for BRSV and PI3V up to 11 and 7 days respectively after vaccination with one dose containing the maximal virus content. Animals should preferably be vaccinated at least 10 days before a period of stress or high infection risk like re-grouping or transport of animals, or at the start of the autumn season. To achieve optimal results, it is recommended to vaccinate all the calves within the same herd. Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 Adverse reactions (frequency and seriousness) Published evidence shows that on rare occasions repeated exposure to RSV may trigger hypersensitivity reactions. In colostrum-deprived animals vaccinated before 3 weeks of age with a 10x overdose of vaccine, transient temperature increase, nutritional scour, abnormal faeces and demeanour were observed. 4.7 Use during pregnancy, lactation or lay The safety and efficacy of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy and lactation. 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.