Target species
Pigs.
Indications for use for each target species
For active immunisation of pigs of a minimum age of 7 days to reduce lung lesions that are caused by Mycoplasma hyopneumoniae.
Onset of immunity: 2 weeks.
Duration of immunity: 6 months after vaccination.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Avoid stress in the animals around the time of vaccination.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product contains animal oil. 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:
Very common (>1 animal / 10 animals treated): | Injection site swelling1 Shivering2 Piloerection2 Depression2, Elevated temperature2/3 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Anaphylactic-type reaction Neurological signs |
1May reach 0.3 cm in diameter (palpable, but not visible) and last for up to 2 days.
2Within 4 hours after vaccination and spontaneously resolving within 24 hours without treatment.
3Body temperature increase up to 1.9°C.
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:
Do not use in pregnant or lactating animals.
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
One dose (2 ml) per animal should be administered intramuscularly in the neck to pigs from the age of 7 days onwards.
Shake vaccine well before administration and intermittently during the process of vaccination.
It is good practice to allow the vaccine to warm to body temperature in the hand or pocket before administration, to avoid the discomfort of injection of a cold liquid.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
After administration of a two-fold overdose by the recommended route to 3 weeks-old pigs, no other symptoms than those described under section “Adverse events” can be observed. However, the duration may be prolonged (body temperature increases up to 2 days and local tissue reactions up to 3 days) and the area of local tissue reactions may reach 1.0 cm in diameter. Administration of an overdose of the vaccine has not been investigated in 1 week-old piglets.
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.