Pigs

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection.

Onset of immunity: 2 weeks after vaccination.

Duration of immunity: 26 weeks after vaccination.

None

Vaccinate healthy animals only.

Use of the vaccine in boars has not been evaluated.

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.

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.

Pigs:

* Mostly consisting of hard non-painful swellings of up to 2 cm diameter. A biphasic pattern of the injection site swelling, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed. In individual pigs the size may increase to 6.5 cm and redness and/or scabs may be observed. The injection site swellings disappear 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 last section of the package leaflet for respective contact details.

Can be used during pregnancy and lactation

Safety and efficacy data are available in pigs from 3 weeks of age onwards which demonstrate that this vaccine can be administered mixed with Porcilis Lawsonia ID (see section ‘Amounts to be administered and administration route’) and/or non-mixed with Porcilis M Hyo ID ONCE and/or non-mixed with Porcilis PRRS (intradermal route). The administration site of non-mixed vaccines should be separated by at least 3 cm. The product literature of Porcilis Lawsonia ID, Porcilis M Hyo ID ONCE and Porcilis PRRS should be consulted before administration.

Adverse events are as described in section ‘Adverse events’, except for local injection site reactions where a maximum size of up to 7 cm may occur in individual pigs. Injection site reactions may last up to 7 weeks and are very commonly accompanied by redness and crusts. If the crust is rubbed off, some small skin damage may be commonly observed. Elevated body temperature on the day of vaccination (mean 0.3 °C, in individual pigs up to 2 °C) is common. The animal’s temperature returns to normal within 1 ‑ 2 days after the peak temperature is observed. Lying down and malaise can be uncommonly observed in vaccinated pigs.

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

For intradermal use.

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

Avoid multiple broaching.

Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg (all pigs) or perianal area (in pigs for reproduction) using a 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.

Safety and efficacy of Porcilis PCV ID have been demonstrated using the device IDAL.

Vaccinate once from an age of 3 weeks onwards and re-vaccination at 26 weeks interval is recommended.

Porcilis PCV ID may be used to reconstitute Porcilis Lawsonia ID lyophilisate shortly before vaccination in pigs from 3 weeks of age onwards as follows:

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

1. Allow Porcilis PCV ID to reach room temperature and shake well before use.

2. Add approximately 5 - 10 ml of Porcilis PCV ID to the Porcilis Lawsonia ID lyophilisate and mix briefly.

3. Withdraw the reconstituted concentrate from the vial and transfer it back into the vial with 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.

Dosage:

A single dose (0.2 ml) of Porcilis Lawsonia ID mixed with Porcilis PCV ID is given intradermally in the neck.

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

Avoid introduction of a contamination by multiple broaching.

No data available.

Zero days.