Each dose of 1 ml contains:

Porcine circovirus type 2 ORF2 capsid protein: RP* 1.0–3.75

* Relative potency (ELISA test) by comparison with a reference vaccine

Carbomer: 1 mg

Clear to slightly opalescent, colourless to yellowish suspension

For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (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.

Intramuscular use.

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

Shake well before use.

Avoid introduction of contamination during use.

Vaccines devices should be used in accordance with the device instructions provided by the manufacturer. After correct handling in accordance with the mixing instructions no leakage should occur. In case of any leakage or incorrect handling of the product the bottle should be discarded.

Avoid multiple broaching.

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 equipment should be used:

∙ Use the same volumes of Ingelvac CircoFLEX 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 CircoFLEX.

- Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

- After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

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.

To ensure correct mixing with the TwistPak bottles follow the steps as described below:

1. Twist and remove the red base of the bottle of Ingelvac MycoFLEX to uncover the connection system. The red base could be used upside down as a stand to position of the Ingelvac MycoFLEX bottle upside down.

Twist and remove the green base of the Ingelvac CircoFLEX bottle.

2. Rotate and align the connection ends of the two bottles until they engage.

3. Firmly push the bottles together until they touch one another completely.

A click confirms that the bottles are engaged.

4. Twist the two vaccine bottles clockwise to complete the coupling of both bottles.

5. To ensure appropriate mixing, slowly invert the locked bottles 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.

6. 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 to the instructions given in section 5.5.

When mixed with Ingelvac PRRSFLEX EU:

∙ Vaccinate only pigs as from 17 days of age.

∙ Cannot be administered in pregnant or lactating pigs.

When mixed with Ingelvac PRRSFLEX EU the following equipment should be used:

∙ Use the same volumes of Ingelvac CircoFLEX and Ingelvac PRRSFLEX EU.

∙ Ingelvac CircoFLEX hereby replaces the solvent of Ingelvac PRRSFLEX EU.

∙ 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 CircoFLEX.

2. Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac PRRSFLEX EU.

3. Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac PRRSFLEX EU. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

4. To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac PRRSFLEX until the cake is fully dissolved.

5. Administer one single injection dose (1 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 within 4 hours after mixing. Any unused mixture or waste material should be disposed according to the instructions given in the Disposal Advice section.

Not applicable.

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

Not applicable.

Pigs

1 Mild and transient on the day of vaccination.

2 Should be treated symptomatically.

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.

Can be used during pregnancy and lactation.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with either Boehringer Ingelheim’s Ingelvac MycoFLEX or Ingelvac PRRSFLEX EU and administered at one injection site. The product literature of Ingelvac MycoFLEX and Ingelvac PRRS FLEX EU should be consulted before administration.

After administration of Ingelvac CircoFLEX mixed with Ingelvac PRRSFLEX EU the following adverse events may occur: In individual pigs, the temperature increase after associated use rarely exceeds 1.5°C but stays below an increase of 2°C. The temperature returns to normal within 1 day after the peak temperature is observed. Transient local injection site reactions, which are restricted to a slight redness, may rarely occur directly after vaccination. Reactions resolve within 1 day. Immediate mild hypersensitivity-like reactions were commonly observed after vaccination, resulting in transient clinical signs such as vomiting and rapid respiration, which resolved within a few hours without treatment. Transient purple skin discoloration was uncommonly observed and resolved without treatment. Appropriate precautions to minimise handling stress during the administration of the product may lower the frequency of hypersensitivity-like reactions.

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.

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

Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac MycoFLEX or Ingelvac PRRSFLEX EU (both mixtures not for use in pregnant or lactating pigs).

Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.

Ingelvac MycoFLEX may be not authorised in certain Member States.

Ingelvac PRRSFLEX EU may be not authorised in certain Member States.

Keep out of the reach and sight of children. For animal treatment only - to be supplied only on veterinary prescription.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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

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

Do not freeze.

Protect from light.

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

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Cardboard box of either 1 or 12 high density polyethylene or TwistPak bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).

Each bottle is closed with a chlorobutyl stopper and lacquered aluminium seal.

Not all pack sizes may be marketed.

This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.

Boehringer Ingelheim Vetmedica GmbH

UK(NI): EU/2/07/079/001-008 and EU/2/07/079/009-016 (TwistPak)