Target Species
Pigs.
Indications for use
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.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
This vaccine is intended for intradermal administration only.
The lyophilisate must be reconstituted in the dedicated “Solvent for Porcilis Lawsonia ID” or in Porcilis PCV ID following the instructions given in section Amounts to be administered and administration route
Special precautions for use
Not applicable.
Operator warnings
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.
Adverse Reactions
Pigs:
Very common (>1 animal /10 animals traeted): | Elevated temperature1, injection site swelling2 |
1. Mean increase of 0.1 °C, up to 1.4 °C in individual pigs. The animals return to normal temperature within 1 day after vaccination.
2. Mean diameter of approximately 1 cm, in individual pigs up to 5 cm. Injection site swelling disappears within 4 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.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Interactions
Safety and efficacy data, except for protection against mortality, are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be administered mixed with Porcilis PCV ID and/or non-mixed with Porcilis M Hyo ID ONCE and/or non-mixed with Porcilis PRRS (intradermal route) providing that administration sites of vaccines are separated by at least 3 cm.
The product literature of Porcilis PCV ID, Porcilis M Hyo ID ONCE and Porcilis PRRS should be consulted. Adverse events are as described in section “Adverse reactions”, except for injection site swelling where a maximum size of up to 7 cm may occur in individual pigs. Injection site swellings are very commonly accompanied by redness and crusts and disappear within 6 weeks after vaccination. Lying down and malaise can be uncommonly observed in vaccinated pigs. Elevated temperatures (mean 0.3 °C, individual pigs up to 1.2 °C) may commonly occur on the day of vaccination. The animals return to normal 1 to 2 days after the peak temperature is observed.
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.
Amounts to be administered and administration route
Intradermal use.
Reconstitute the lyophilisate in the solvent or in Porcilis PCV ID as follows:
Lyophilisate | Solvent for Porcilis Lawsonia ID or Porcilis PCV ID |
50 doses | 10 ml |
100 doses | 20 ml |
For proper reconstitution and correct administration, use the following procedure:
1. Allow the solvent or Porcilis PCV ID to reach room temperature and shake well before use.
2. Add approximately 5-10 ml of the solvent or Porcilis PCV ID to the lyophilisate vial 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 ID. 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.
Avoid introduction of a contamination by multiple broaching.
Dosage
A single dose of 0.2 ml of reconstituted vaccine in pigs starting at 3 weeks of age.
Vaccinate pigs by the intradermal route using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin.
Safety and efficacy of Porcilis Lawsonia ID have been demonstrated using the device IDAL.
Visual appearance after reconstitution: homogenous white to nearly white emulsion after shaking.
Overdose
No adverse reactions other than the local reactions described in section 4.6 were observed after the administration of a double dose of Porcilis Lawsonia ID reconstituted in solvent.
Withdrawal periods
Zero days.