Ingelvac CircoFLEX

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  • Heiti vöru:
  • Ingelvac CircoFLEX
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Staðsetning

  • Fáanlegt í:
  • Ingelvac CircoFLEX
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Pigs
  • Lækningarsvæði:
  • Immunologicals for suidae,
  • Ábendingar:
  • For active immunisation of pigs over the age of two 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 protection occurs as early as two weeks post vaccination and lasts for at least 17 weeks.
  • Vörulýsing:
  • Revision: 14

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/000126
  • Leyfisdagur:
  • 12-02-2008
  • EMEA númer:
  • EMEA/V/C/000126
  • Síðasta uppfærsla:
  • 30-03-2019

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/595160/2007

EMEA/V/C/000126

EPAR summary for the public

Ingelvac CircoFLEX

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

Ingelvac CircoFLEX

EMA/595160/2007

Page 2/2

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

rates.

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

leaflet.

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.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Ingelvac CircoFLEX suspension 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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Ingelvac CircoFLEX suspension for injection for pigs

3.

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.

Adjuvant: Carbomer

Clear to slightly opalescent, colourless to yellowish suspension for injection.

4.

INDICATIONS

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.

5.

CONTRAINDICATIONS

None.

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 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:

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

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.

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.

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

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.

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

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

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 Boehringer Ingelheim´s 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

http://www.ema.europa.eu/.

15.

OTHER INFORMATION

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.