Porcilis PCV ID - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Porcilis PCV ID emulsion for injection for pigs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Intervet International B.V.

Wim de Korverstraat 35

5831 AN Boxmeer

The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis PCV ID emulsion for injection for pigs

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

Each dose of 0.2 ml contains:

Active substance:

Porcine circovirus type 2 ORF2 subunit antigen > 1436 AU1

Adjuvants:

dl-a-tocopheryl acetate Light liquid paraffin 1Antigenic units as determined in the in vitro antigenic mass assay.

Emulsion for injection.

Homogenous, white to nearly white emulsion after shaking.

• 4. INDICATION(S)

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection.

Onset of immunity: 2 weeks after vaccination.

Duration of immunity: 23 weeks after vaccination.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

Transient local reactions mostly consisting of hard non-painful swellings of up to 2 cm diameter were very commonly observed in laboratory studies and field trials. A biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed. In individual pigs the size may increase to 4 cm and redness may be observed. The local reactions disappear completely within approximately 5 weeks after vaccination.

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

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – 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)

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Pigs for fattening.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For intradermal use.

Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin.

Safety and efficacy of Porcilis PCV ID have been demonstrated using the device IDAL.

Vaccination scheme:

Vaccinate once from an age of 3 weeks onwards.

ADVICE ON CORRECT ADMINISTRATION

Before using the vaccine allow it to reach room temperature (15 °C – 25 °C) and shake well before use.

Avoid multiple broaching.

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from direct sunlight.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after first opening the container: 8 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

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 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.

Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.

The product literature of Porcilis M Hyo ID ONCE should be consulted. In case both vaccines are used on the same day the size of the local reactions may increase up to 6 cm in individual pigs, may last 7 weeks and are very commonly accompanied by redness and crusts. In the event that the crust is rubbed off, some small skin damage may be commonly observed. Moreover, a transient increase in body temperature on the day of vaccination of about 0.2 °C is common. In individual pigs this temperature may increase up to 2 °C. The animal’s tempe­rature returns to normal within 1–2 days after the peak temperature is observed.

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

Incompatibilities

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED