Pigs for fattening

For the active immunization of fattening pigs from 3 weeks of age to reduce the occurrence and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.

Onset of immunity: 3 weeks after the vaccination

Duration of immunity: 26 weeks after vaccination

None.

Vaccinate healthy animals only.

The data available are not sufficient to exclude the interaction of maternally derived antibodies against Mycoplasma hyopneumoniae with vaccine uptake. Interaction with maternally derived antibodies is known and should be taken into consideration. It is recommended to delay vaccination in piglets with residual MDA against Mycoplasma hyopneumoniae at the age of 3 weeks.

Not applicable.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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 and 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.

Special precautions for the protection of the environment:

Not applicable.

Target species:

Pigs for fattening

Very common (>1 animal / 10 animals treated):	Elevated temperature* Injection site swelling**
Uncommon (1 to 10 animals / 1,000 animals treated):	Hypersensitivity reaction*** Vomiting***
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Anaphylactic shock**** Recumbency****

*On the day of vaccination a transient mean increase in body temperature of about 1.3oC is very common. In an individual pig this increase might reach 2oC, but in all cases body temperature is back to normal the next day.

** A local reaction at the site of injection in the form of a swelling of a diameter up to 5 cm can be very common, which can last for three days. These reactions are of transient nature and do not need further treatment.

*** Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting.

**** Serious anaphylactic-type reactions (shock, recumbency) which may be fatal have been reported very rarely. Such reactions require prompt symptomatic treatment.

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 also the last section of the package leaflet for respective contact details.

Not applicable.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Circovac and administered to piglets at one injection site. Vaccinate piglets from 3 weeks of age.

Onset of immunity: 3 weeks after vaccination when mixed with Circovac

Duration of immunity: 23 weeks when mixed with Circovac.

In case of mixing with Circovac, slight and transient local reactions may occur very commonly after the administration, mainly swelling (0.5 cm - 5 cm), mild pain and redness as well as in some cases oedema. These reactions resolve spontaneously within maximum 4 days. Transient lethargy may occur very commonly on the day of vaccination which resolves spontaneously within 1-2 days. An increase in individual rectal temperature of up to 2.5°C may occur commonly lasting less than 24 hours. The above adverse reactions were observed in clinical studies.

The product literature of Circovac should be consulted before mixed administration.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except when mixed with Circovac. 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.

Shake well before use.

Use sterile syringe and needle, respect aseptic conditions of vaccination.

When Hyogen is used alone:

Intramuscular use.

Vaccinate pigs in the side of their neck.

Administer a single dose of 2 ml from 3 weeks of age.

When Hyogen is mixed with Circovac:

The mixed use is restricted to the 100 doses (200 ml) presentations of Hyogen and to the 100 doses presentations (50 ml of reconstituted vaccine) of Circovac.

Piglets from 3 weeks of age:

Vaccine devices should be used under aseptic conditions and in accordance with the device instructions provided by the manufacturer.

Prepare Circovac by vigorously shaking the vial of antigen suspension and injecting its content into the vial of emulsion containing adjuvant.

Mix 200 ml of Hyogen and 50 ml of Circovac and shake gently until a homogeneous white emulsion is obtained.

Administer one 2.5 ml dose of the mixture by intramuscular injection, in the side of the neck.

Use the entire vaccine mixture immediately after mixing.

As the vaccine is inactivated, studies investigating the safety of an overdose administration are not required.

Zero days.