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EPAR summary for the public
porcine circovirus type 2 vaccine
This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX. It
explains how the Agency assessed this veterinary medicine to recommend its authorisation in the
European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to
use Ingelvac CircoFLEX.
For practical information about using Ingelvac CircoFLEX, animal owners or keepers should read the
package leaflet or contact their veterinarian or pharmacist.
What is Ingelvac CircoFLEX and what is it used for?
Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine
circovirus type 2 (PCV2). PCV2 infections can produce clinical signs such as weight loss or failure to
grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
How is Ingelvac CircoFLEX used?
Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a
prescription. It is given by injection into the muscle as a single dose. The vaccine starts to be effective
2 weeks after vaccination and protection lasts for 17 weeks.
For further information, see the package leaflet.
How does Ingelvac CircoFLEX work?
Ingelvac CircoFLEX is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural
defences) how to defend itself against a disease. Ingelvac CircoFLEX contains small amounts of a
protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as
‘foreign’ and reacts by building up an active immune response. In the future, the immune system will
be able to react against the virus more quickly when it is exposed to the virus. This active immune
response will help to protect the pig against the disease caused by this virus.
What benefits of Ingelvac CircoFLEX have been shown in studies?
Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds. These
studies were performed under laboratory as well as under typical European farming conditions. The
trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets. It also
reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, the number of runts and death
What are the risks associated with Ingelvac CircoFLEX?
The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is
a mild and short lived increase in body temperature on the day of vaccination.
For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package
What are the precautions for the person who gives the medicine or comes
into contact with the animal?
No special precautions are required.
What is the withdrawal period in food-producing animals?
The withdrawal period is the time required after administration of a medicine before an animal can be
slaughtered and the meat used for human consumption.
The withdrawal period for meat from pigs treated with Ingelvac CircoFLEX is ‘zero days’, which means
there is no mandatory waiting time.
Why is Ingelvac CircoFLEX approved?
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac
CircoFLEX’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Other information about Ingelvac CircoFLEX:
The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac
CircoFLEX on 13 February 2008.
The full EPAR for Ingelvac CircoFLEX can be found on the Agency’s website: ema.europa.eu/Find
medicine/Veterinary medicines/European public assessment reports. For more information about
treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or
contact their veterinarian or pharmacist.
This summary was last updated in March 2017.
B. PACKAGE LEAFLET
Ingelvac CircoFLEX suspension for injection for pigs
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
Boehringer Ingelheim Vetmedica GmbH
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac CircoFLEX suspension for injection for pigs
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each dose (1 ml) contains:
Porcine circovirus type 2 ORF2 protein: RP* 1.0–3.75
* Relative potency (ELISA test) by comparison with a reference vaccine.
Clear to slightly opalescent, colourless to yellowish suspension for injection.
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 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.
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.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
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
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.
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:
Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac
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.
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
Administer one single injection dose (
) 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.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2
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 bottle: use immediately.
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
Boehringer Ingelheim’s 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
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.
Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac
MycoFLEX (not for use in pregnant or lactating pigs).
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
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency
This vaccine is designed to stimulate the development of an active immune response to porcine
circovirus type 2.
Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml
(250 doses). Not all pack sizes may be marketed.
Ingelvac MycoFLEX may be not authorised to use in certain Member States.