Target species Pigs (fattening pigs or future breeders until first reproductive service). 4.2 Indications for use, specifying the target species For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae. Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks. 4.3 Contraindications None. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Vaccinate healthy animals only In case of anaphylactic-type reactions, the administration of epinephrine is recommended. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 Adverse reactions (frequency and seriousness) Adverse reactions are very rare (less than 1 animal in 10,000 animals, including isolated reports): - anaphylactic-type reactions may occur and should be treated symptomatically (e.g. epinephrine) - transient swelling up to four centimetres in diameter, sometimes associated with redness of the skin, may be observed at the injection site. These swellings may last up to five days. - a transient mean increase in rectal body temperature of about 0.8 °C lasting up to 20 hours after vaccination may be observed. 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 Not applicable. 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 mixed with Boehringer Ingelheim’s Ingelvac CircoFLEX and administered at one injection site. 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.