Ingelvac PCV FLEX - Patient leaflet, side effects, dosage

.. _ zP

• 4. INDICATIONS

For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2).

Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

Onset of immunity: 2 weeks post vaccination

Duration of immunity: at least 17 weeks.

• 6. ADVERSE REACTIONS

A mild and transient hyperthermia very commonly occurs on the day of vaccination.

On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.

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).

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

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

Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

Avoid introduction of contamination during use.

Avoid multiple vial broaching.

Vaccination devices should be used in accordance with the device instructions provided by the manufacturer.

When mixed with Ingelvac MycoFLEX:

• Vaccinate only pigs as from 3 weeks of age.
• Cannot be administered in pregnant or lactating pigs.

When mixed with Ingelvac MycoFLEX the following recommendations should be followed:

• Use the same volumes of Ingelvac PCV FLEX and Ingelvac MycoFLEX.
• Use a pre-sterilised transfer needle. Pre-sterilised transfer needles (CE certified) are commonly

available via medical equipment suppliers.

To ensure correct mixing follow the steps as described below:

• 1. Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.

• 2. – Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac PCV

FLEX.

• – Transfer the Ingelvac PCV FLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac PCV FLEX to facilitate the transfer.

• – After the transfer of the full content of Ingelvac PCV FLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac PCV FLEX.

• 3. To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.

• 4. Administer one single injection dose (2 ml ) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

Use the entire vaccine mixture immediately after mixing. Any unused mixture or waste material should be disposed according with local requirements.

• 10. WITHDRAWAL PERIOD

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C-8 °C).

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

Shelf life after first opening the immediate packaging: use immediately.

• 12. SPECIAL WARNINGS

Vaccinate healthy animals only.

Pregnancy and lactation

Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Ingelvac MycoFLEX and administered at one injection site.

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.

Overdose (symptoms, emergency procedures, antidotes)

Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.

Incompatibilities

Do not mix with any other veterinary medicinal product, except with Ingelvac MycoFLEX (not for use in pregnant or lactating pigs).

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

Medicines should not be disposed of via wastewater or household waste. 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

Detailed information on this product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION