Pigs

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).

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.

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

Vaccinate healthy animals only.

Not applicable.

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.

Mild transient local reactions consisting of non-painful skin inflammations, of less than 3 cm in diameter are very common. Moderate inflammation (between 3-5 cm) at the inoculation site is commonly observed from 4 hours post-vaccination to day one.

These local reactions can be observed during the first week after vaccination and last for 1 to 4 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.

A slight transient increase in body temperature (mean 0.3 ºC, in individual pigs less than 2 ºC) occurred commonly in field studies. This slight increase subsided spontaneously within 48 hours without treatment.

Anaphylactic-type reactions (e.g. vomiting, circulatory disorders, dyspnoea) which might be life-threatening, may occur very rarely in some sensitive animals based on post-marketing safety experience. Under these circumstances, appropriate symptomatic treatment should be administered.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The use is not recommended during pregnancy and lactation.

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.

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 the HIPRADERMIC device.

Safety and efficacy of MHYOSPHERE PCV ID have been demonstrated using the device HIPRADERMIC.

---- specific details of administration for Northern Ireland -------------

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).

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None known.

Zero days.