Pigs.

For the active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by Mycoplasma hyopneumoniae.

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 22 weeks after vaccination.

None.

Vaccinate healthy animals only.

Not applicable.

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 veterinary medicinal 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 medical advice again.

To the physician:

This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal 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.

Pigs:

1 A transient elevated temperature (mean 0.7 °C, in individual pigs up to 2 °C) very commonly occurs on the day of vaccination. The animals return to normal 1 to 2 days after the peak temperature is observed.

2 A transient injection site swelling mostly consisting of hard non-painful button-like swellings of a diameter of up to 4 cm can be very commonly observed. In individual pigs redness and/or a biphasic pattern of the injection site swelling, consisting of an increase and decrease followed by another increase and decrease of the size, may be observed. The injection site swelling disappears completely within approximately 7 weeks after vaccination.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.

Not applicable.

Safety and efficacy data are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be administered on the same day, but non-mixed with Porcilis PRRS (intradermal route) and/or non-mixed with Porcilis PCV ID or with Porcilis PCV ID mixed with Porcilis Lawsonia ID providing that non-mixed administration sites of vaccines are separated by at least 3 cm. Adverse events are as described in section 4.6, except for injection site swelling where a maximum size of up to 6 cm may occur in individual pigs. Injection site swellings may last 8 weeks and are very commonly accompanied by redness and crusts. In the event that the crust is rubbed off, some small skin damage may be commonly observed.

The product information of Porcilis PCV ID, Porcilis Lawsonia ID and Porcilis PRRS should be consulted before administration.

Intradermal use.

Intradermal administration of 0.2 ml per animal preferably at the sides of the neck or along the muscles of the back using an multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2 ml ± 10%) through the epidermal layers of the skin. A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.

Safety and efficacy of Porcilis M Hyo ID ONCE have been demonstrated using the device IDAL.

Vaccination scheme:

Vaccinate once from an age of 2 weeks onwards.

Before using the vaccine allow it to reach room temperature (15–25 °C) and shake well before use.

Avoid introduction of contamination.

No adverse reactions other than those mentioned under section ‘‘interactions’’ have been observed after administration of a double dose. However, these reactions may be more pronounced. A mean transient temperature increase of 1 °C may be observed. Local reactions may be observed with a maximum diameter of up to 7 cm. The local reactions disappear completely within approximately 9 weeks after vaccination.

Zero days.