Target species
Pigs for fattening.
Indications for use for each target species
Active immunisation against Mycoplasma hyopneumoniae infection in pigs to reduce the frequency and severity of lung lesions.
Onset and duration of immunity: not established.
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:
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:
Rare (1 to 10 animals / 10,000 animals treated): | Injection site swelling1 |
1 Transient, of 2 cm in diameter, spontaneously resolving within a few days.
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 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.
Fertility:
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
Intramuscular use.
A dose of 2 ml must be administered intramuscularly in the neck behind the ear twice with an interval of 2 weeks, to pigs from the age of 1 week and before the age of 10 weeks.
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)
The administration of an overdose may very commonly result in the same type of reaction as seen after administration of a single dose (see section "Adverse events").
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.