White homogenous emulsion.

* Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.

For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and faecal shedding caused by infection with PCV2.

For active immunisation of pigs from the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.

3 weeks after vaccination.

23 weeks after vaccination.

One dose of 2 ml per animal should be administered intramuscularly in the neck behind the ear to pigs from 3 weeks of age.

Shake vaccine well before administration and intermittently during the process of vaccination.

The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions. The vaccine is to be administered aseptically. During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.

No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.

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

Vaccinate only healthy animals.

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 made on a case by case basis.

Do not mix with any other veterinary medicinal product.

A transient increase in body temperature (on average 1°C) was very commonly observed during the first 24 hours after vaccination in laboratory and field trials. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2°C. This resolves spontaneously within 48 hours without treatment.

Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation are very common and may last for up to 2 days (based on laboratory safety studies). The area of local tissue reactions is in general below 2 cm in diameter. In a laboratory study, a post-mortem examination of the injection site, performed 4 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.

Immediate mild hypersensitivity-like reactions were uncommonly observed after vaccination, resulting in transient clinical signs such as vomiting, diarrhoea or depression, in field efficacy trials. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rare cases. In case of such reactions, appropriate treatment is recommended.

The frequency of possible adverse effects is defined using the following convention:

A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose. This resolved spontaneously within 24 hours without treatment. Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.

Zero days.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Store and transport refrigerated (2°C - 8°C).

Do not freeze. Protect from light.

A slight black deposit may appear and the emulsion may separate into two distinct phases during storage. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.

Shelf-life after first opening: use immediately.

Keep out of the sight and reach of children.

For animal treatment only.

Cardboard box containing 1 vial of 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses).

Cardboard box containing 10 vials of 50 ml (25 doses) or 100 ml (50 doses).

Cardboard box containing 4 vials of 250 ml (125 doses).

Not all pack sizes may be marketed.

Not applicable.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

UK(GB): Vm 42058/5072

UK(NI): EU/2/15/190/001-006