Target species
Pigs (for fattening).
Indications for use for each target species
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.
Onset of immunity: 3 weeks.
Duration of immunity: 23 weeks.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Pigs (for fattening):
Very common (>1 animal / 10 animals treated): | Elevated temperature1 Injection site inflammation2, Injection site pain3, injection site reddening3, injection site swelling3 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Hypersensitivity reactions (e.g. depression, diarrhoea or vomiting)4 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylaxis5 |
1Transient; observed during the first 24 hours after vaccination. On average 1 °C but may exceed 2°C in individual pigs. This resolves spontaneously within 48 hours without treatment.
2Post-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 lymphocytic-granulomatous inflammatory response.
3The area of local tissue reactions is in general below 2 cm in diameter and may last up to 2 days.
4Normally resolve without treatment.
5In case of such reactions, appropriate treatment is recommended.
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
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Pregnancy and lactation:
Do not use during pregnancy and lactation.
Fertility:
No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
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
Intramuscular use.
Administer one dose of 2 ml to pigs in the neck behind the ear.
Vaccination schedule:
One injection from 3 weeks of age.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
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
Not applicable.
Withdrawal periods
Zero days.