Target species
Fattening pigs
Indications for use, specifying the target species
For active immunisation of piglets from 3 days of age to reduce lung lesions related to infection by Mycoplasma hyopneumoniae in fattening animals.
Onset of immunity : 18 days following vaccination.
Duration of immunity : 26 weeks following vaccination.
For active immunisation of piglets from 3 weeks of age to reduce coughing and losses in weight gain related to infection by Mycoplasma hyopneumoniae in fattening animals.
Onset of immunity : 3 weeks following vaccination.
Duration of immunity : 23 weeks following vaccination
Contraindications
None
Special warnings
None.
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this oil-based product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions (frequency and seriousness)
Local tissue reactions in the form of a transient swelling at the injection site (max. diameter 2.5 cm) are very common (more than 1 in 10 animals) and may last for up to 3 days
Transient increase in rectal temperature (up to 1.9°C above baseline) can be observed for up to 4 days post vaccination.
As part of the immune reaction following vaccination, inflammatory cell infiltration and/or fibrosis may occur in the muscle tissue at the injection site lasting for at least 14 days.
Hypersensitivity reactions, including shock and death may occur in very rare cases. Appropriate treatment (for example glucocorticoid intravenously or adrenaline intramuscularly) should be administered.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
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.
Amounts to be administered and administration route
Shake and aseptically administer a single 2 ml injection by deep intramuscular route in the lateral neck muscle. Needle length and diameter should be adapted to the age of the animals.
Vaccination programme:
One single dose of 2 ml of vaccine should be given.
Vaccination should be performed prior to the period of risk. Infection usually occurs within the first month of life.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Injection site reactions observed after the administration of one overdose are similar to those following a single dose of vaccine. Very commonly (more than 1 in 10 animals), animals vaccinated with an overdose develop a palpable injection site reaction of up to 3 cm in diameter that resolves within 2 days.
A lower growth rate has been observed in animals administered a double dose of vaccine.
Withdrawal period
Zero days.