Special precautions for safe use in the target species:
Not applicable.
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.
Special precautions for the protection of the environment:
Not applicable.
Adverse Events
Pigs
Very common (> 1 animal / 10 animals treated): | Elevated temperature1 |
Very rare (< 1 animal / 10 000 animals treated, including isolated reports): | Anaphylaxis2 |
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.
Use during pregnancy, lactation or lay
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 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Following the administration of a 4-fold overdose of vaccine no adverse events other than those described under section Adverse Events have been observed.
Major 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).
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
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.