Rispoval Pasteurella POM 5 Dose

4.1 Target Species Cattle from 3 months of age. 4.2 Indications for Use, Specifying the Target Species For active immunisation of cattle to reduce lesions and respiratory disease caused by Mannheimia haemolytica biotype A, serotype 1. Studies carried out show that a single dose is sufficient to confer protection from challenge by Mannheimia haemolytica within 7 days of vaccination. The vaccine will protect animals for at least 17 weeks. 4.3 Contraindications Do not vaccinate unhealthy animals, pregnant animals or heifers at the time of breeding. 4.4 Special warnings for each target species Calves should be vaccinated at least 7 days before transport, mixing of animals of different origins, housing or any other event which may cause the animals to be stressed or exposed to new infections. Calves are usually most susceptible during early autumn. The vaccine will protect animals for at least 17 weeks, which will cover the period of risk from pasteurellosis. 4.5 Special precautions for use i) Special precautions for use in animals None. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self-injection. To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek further medical advice. To the doctor: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon. 4.6 Adverse reactions (frequency and seriousness) A transient local swelling at the injection site is very commonly observed within 24 to 48 hours post vaccination. The swellings are up to 14 cm in diameter and usually disappear within 2 weeks post vaccination, with no need for treatment. On rare occasions, the local reaction may take longer to resolve (up to 52 days). A transient increase in rectal temperature (up to a maximum of 40.9°C) is very commonly observed within 1 to 4 hours post vaccination. Temperatures return to normal within 4 days without treatment. Rarely, hypersensitivity reactions may occur. In such cases, appropriate treatment e.g. adrenaline and/or antihistamine should be given without delay. Muscular trembling has also been noted very rarely.” 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) 4.7 Use during pregnancy, lactation or lay Do not vaccinate pregnant animals and heifers at the time of breeding. 4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Rispoval RS. 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.