Emulsion for Injection.

White homogenous emulsion.

Each 2 ml dose contains:

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

Active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, faecal shedding and the lesions in lymphoid tissues associated with PCV2 infection. Protection was demonstrated against porcine circovirus types 2a, 2b and 2d.

Active immunisation of pigs against Mycoplasma hyopneumoniae to reduce the lung lesions associated with Mycoplasma hyopneumoniae infection.

Onset of immunity (both vaccine schedules): 3 weeks after (the last) vaccination.

Duration of immunity (both vaccine schedules): 23 weeks after (the last) vaccination

In addition, vaccination has been shown to reduce body weight gain losses under field conditions.

Vaccinate pigs by the intramuscular route in the neck behind the ear.

A single dose of 2 ml in pigs from 3 weeks of age.

Two injections each of 1 ml in pigs from 3 days of age with an interval of approximately 3 weeks.

Choice of dosing regimen, including age of vaccination should take into account farm circumstances. In situations where the level of maternally-derived antibodies against PCV2 is expected to be moderately high or very high consider delaying the age of vaccination.

Shake 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.

Vaccinate healthy animals only.

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.

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, not exceeding 2.1°C, is very common after vaccination and resolves spontaneously within 24 hours without treatment. In a laboratory study, a post-mortem examination of the injection site, performed 2 weeks after the administration of a repeated single dose of the vaccine, very commonly revealed a mild lymphocytic-granulomatous inflammatory response. Local tissue reactions in the form of swelling at the injection site, below 2 cm in diameter, are common and may last for up to 10 days. Erythema may be uncommonly observed during the first 24 hours after vaccination.

Hypersensitivity reactions, vomiting, incoordination, lethargy, and laboured breathing were uncommonly observed in field studies. The animals mostly recover within 24 hours.

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

In supportive overdose studies, lethargy and polypnoea have been observed. Transient mild injection site swellings can occur for up to 1 day. Transient fever (maximum 41.1ºC) may occur for up to 12 hours.

Zero days.

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 of the veterinary medicinal product as package for sale: 18 months.

Shelf life after first opening the immediate packaging: use immediately.

Keep out of the sight and reach of children.

For animal treatment only.

High density polyethylene vials of 50 ml, of 100 ml and of 250 ml, with a chlorobutyl elastomer closure and sealed with an aluminium cap.

Cardboard box containing 1 vial of 50 ml, 100 ml or 250 ml.

Cardboard box containing 10 vials of 50 ml or 100 ml.

Cardboard box containing 4 vials of 250 ml.

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 42058/5013

UK(NI): EU/2/20/264/001-006