Target species
Pigs (for fattening)
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
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal 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)
Pigs (for fattening):
Very common (>1 animal / 10 animals | Injection site swelling! |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site fibrosis2, Injection site inflammation2, Hypersensitivity reaction3, Elevated Temperature4 |
3Including shock and death. Appropriate treatment that may include intravenous glucocorticoid or intramuscular adrenaline should be administered.
4Up to 1.9° C, for up to 4 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
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 use 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 a 2-fold 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 2-fold overdose of vaccine.
Withdrawal period
Zero days.