Pigs.

For the active immunisation of pigs from 3 weeks of age to reduce diarrhoea, loss of daily weight gain, intestinal lesions, bacterial shedding and mortality caused by Lawsonia intracellularis infection.

Onset of immunity: 4 weeks after vaccination.

Duration of immunity: 21 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 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.

An increase in body temperature very commonly occurs (mean 0.6°C, in individual pigs up to 1.3°C). The animals return to normal temperature within 1 day after vaccination. Local injection site reactions in the form of swelling (< 5 cm diameter) may commonly occur and disappear within 23 days.

In post marketing experience:

Anorexia and lethargy have been reported uncommonly.

Anaphylactic-type reactions have been reported very rarely. If such reactions occur, appropriate treatment is recommended.

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).

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Safety and efficacy data in pigs from 3 weeks of age onwards are available, which demonstrate that this vaccine can be given at the same time with Porcilis PCV M Hyo and/or Porcilis PRRS. When Porcilis Lawsonia is given at the same time with Porcilis PCV M Hyo, these products should be mixed (see below), whereas Porcilis PRRS should always be given at a separate site (preferably at the opposite side of the neck). The product literature of Porcilis PCV M Hyo and/or Porcilis PRRS should be consulted before administration.

In individual pigs the temperature increase after associated use may commonly exceed 2°C. The temperature returns to normal from 1 to 2 days after the peak temperature is observed. Transient local injection site reactions, which are restricted to a slight swelling (maximum 2 cm diameter), may commonly occur directly after vaccination, but reactions may not appear until 12 days after vaccination. All these reactions disappear within 6 days. Hypersensitivity reactions after vaccination may occur uncommonly.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products 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.

Intramuscular use.

Reconstitute the lyophilisate in the solvent or in Porcilis PCV M Hyo as follows:

For proper reconstitution and correct administration, use the following procedure:

1. Allow the solvent or Porcilis PCV M Hyo to reach room temperature and shake well before use.

2. Add 5-10 ml of the solvent or Porcilis PCV M Hyo to the lyophilisate and mix briefly.

3. Withdraw the reconstituted concentrate from the vial and transfer it back into the vial with the solvent or the Porcilis PCV M Hyo. Shake briefly to mix.

4. Use the vaccine suspension within 6 hours of reconstitution. Any vaccine remaining at the end of this time should be discarded.

Needle length and diameter should be adapted to the age of the animal.

Avoid introduction of a contamination by multiple broaching.

Dosage:

A single dose of 2 ml of reconstituted vaccine in pigs starting at 3 weeks of age.

Vaccinate pigs by the intramuscular route in the neck.

Visual appearance after reconstitution: homogenous white to nearly white emulsion after shaking.

No adverse reactions other than the local reactions and the temperature increases described above were observed after the administration of a double dose of Porcilis Lawsonia reconstituted in Porcilis PCV M Hyo.

Zero days.