Target species
Pigs (for fattening).
Indications for use for each target species
Active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal 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 vaccination schedules): 3 weeks after (the last) vaccination.
Duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.
In addition, vaccination has been shown to reduce body weight gain losses under field conditions.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Pigs for fattening:
Very common (>1 animal / 10 animals treated): | Elevated temperature (< 2.1 °C, resolving within 24 hours) Injection site swelling (between 2-5 cm in diameter, for 7 to 10 days)a |
Uncommon (1 to 10 animals / 1,000 animals treated): | Erythema (in first 24 hours) Hypersensitivity reactions: vomiting, incoordination, lethargy, and laboured breathing (most animals recover within 24 hours) |
a 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.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Not applicable.
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 made on a case by case basis.
Administration routes and dosage
Vaccinate pigs by the intramuscular route in the neck behind the ear.
Single dose vaccination schedule:
A single dose of 2 ml in pigs from 3 weeks of age.
Split dose vaccination schedule:
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, it is recommended to use the split dose vaccination schedule or to delay the age of vaccination.
Shake well before administration and intermittently during the process of vaccination.
The use of a multi-dosing syringe or a needle-free device for intramuscular injections is recommended. In each case, use vaccination devices according to the manufacturer’s instructions. For needle-free administration use a needle-free device appropriate to deliver intramuscular injections of 2 ml dose in pigs from 3 weeks of age. Follow manufacturer’s instructions specific to the pressure required to administer the required dose volume, and specific to handling and cleaning processes. Follow any restriction imposed by the device manufacturer specific to animal age or body weight limits.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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 41.1 ºC) may occur for up to 12 hours.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Withdrawal periods
Zero days.