Porcilis^® PCV

Description and Vaccination Program

Description
Porcilis PCV is an inactivated emulsion vaccine containing Porcine Circovirus type 2 ORF2 subunit antigen. The vaccine is indicated to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.

Composition
Active substance
Porcine Circovirus type 2 ORF2 subunit antigen: at least 4.5 log₂ ELISA units.

Adjuvants
Dl-α-tocopheryl acetate     25 mg.
Light liquid paraffin         346 mg.

Excipient
Polysorbate 80.
Simethicon.
Water for injections.

Formulation
Emulsion for injection.

Indications
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.

Vaccination
Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:

In the case of low to medium levels of maternally derived antibodies against PCV2 a single vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.

When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3-5 days, the second injection (2 ml) 2-3 weeks later.

High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus. In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule. In case of doubt, apply the two shot vaccination schedule.

Onset of protection: 2 weeks after vaccination.
Duration of protection: 22 weeks after vaccination.

Method of administration
2 ml by intramuscular injection in the neck, in the area behind the ear.

Withdrawal period
Zero days.

Presentation
Cardboard boxes with either 1 or 10 PET vials. Various sizes are available in different countries.
Vials are closed with a nitryl rubber stopper and a coded aluminium cap.

Not all pack sizes may be marketed.

Special precautions for use in animals
Vaccinate only healthy animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This 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 product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:
This 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.

Adverse reactions (frequency and seriousness)
Transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivity-like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination. Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.

Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Vaccine must be warmed to room temperature at least 3 hours before use.

Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.

Contraindications
None.

Special warnings
From the data provided, it can be concluded that a full dose regimen of vaccination breaks through medium to high levels of maternally derived antibodies in piglets.
No data are available on the use of the vaccine in breeding boars.