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AstraZeneca

Ingelvac CircoFLEX
inactivated porcine circovirus vaccine


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. Alternatively, you can report via your national reporting system {national system details}.


  7. TARGET SPECIES


    Pigs


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


    Intramuscular use.

    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. 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.


When mixed with Ingelvac MycoFLEX:


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.


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Use the entire vaccine mixture within 4 hours after mixing. Any unused mixture or waste material should be disposed according to local requirements.


  1. WITHDRAWAL PERIOD


    Zero days.


  2. 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 bottle: use immediately.


  3. SPECIAL WARNINGS


    Special warnings for each target species: Vaccinate healthy animals only.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

    the label to the physician.


    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 either with Boehringer Ingelheim’s Ingelvac MycoFLEX or Ingelvac PRRSFLEX EU and administered at one

    injection site. The product literature of Ingelvac MycoFLEX and Ingelvac PRRSFLEX EU should be

    consulted before administration.


    After administration of Ingelvac CircoFLEX mixed with Ingelvac PRRSFLEX EU the following adverse reactions 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.


    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 or Ingelvac PRRSFLEX EU (both mixtures not for use in pregnant or lactating pigs).


  4. 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.


  5. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    /.


  6. 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 high density polyethylene or TwistPak 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. Ingelvac PRRSFLEX EU may be not authorised to use in certain Member States.