Target species
Pigs
Indications for use, specifying the target species
For the active immunisation of pigs:
to reduce lung lesions associated with porcine enzootic pneumonia caused by Mycoplasma hyopneumoniae. Also, to reduce the incidence of these lesions (as observed in field studies).
to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by Porcine circovirus type 2 (PCV2). Efficacy against PCV2 genotypes a, b and d has been demonstrated in field studies.
to reduce culling rate and the loss of daily weight gain caused by Mycoplasma hyopneumoniae and/or PCV2 related diseases (as observed at 6 months of age in field studies).
Mycoplasma hyopneumoniae:
Onset of immunity: 3 weeks after vaccination
Duration of immunity: 23 weeks after vaccination
Porcine circovirus type 2:
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 22 weeks after vaccination
In addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of PCV2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.
Contraindications
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special warnings for each target species
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 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:
Very common (> 1 animal / 10 animals treated): | Injection site inflammation1 Depression2 |
Common (1 to 10 animals / 100 animals treated): | Injection site inflammation3 Elevated temperature4 |
Very rare (< 1 animal / 10 000 animals treated, including isolated reports): | Anaphylactic-type reaction5 |
1Mild transient local reactions consisting of non-painful skin inflammations, of less than 3 cm in diameter are very common.
2A slight depression, which subsides in less than 24 hours without treatment is very commonly observed.
3Moderate inflammation (between 3-5 cm) at the inoculation site is commonly observed from 4 hours post-vaccination to day three. These local reactions can be observed during the first week after vaccination and last for 1 to 5 days. One or two weeks later, these local reactions can reappear lasting for 1 to 7 days. Local reactions disappear completely within approximately 3 weeks after vaccination without treatment.
4A slight transient increase in body temperature (mean 0.6 ºC, in individual pigs less than 2 ºC) that subsides without treatment.
5Anaphylactic-type reactions (e.g. vomiting, circulatory disorders, dyspnoea) which might be life-threatening, may occur in some sensitive animals. Under these circumstances, appropriate symptomatic treatment should be administered.
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:
The use is not recommended during pregnancy and 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
For intradermal use.
Before use allow the vaccine to reach room temperature.
Shake well before use.
For intradermal use.
Before use allow the vaccine to reach room temperature.
Shake well before use.
Administer one dose of 0.2 mL to pigs from 3 weeks of age onwards by intradermal administration at the sides of the neck using a suitable needle-free device able to administer 0.2mL doses per shot (with an injection stream diameter of 0.25-0.30 mm and a peak force of injection of 0.9-1.3 N).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None known.
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 period(s)
Zero days.