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POM-V Prescription Required

Ingelvac PRRSFLEX EU Lyophilisate and Solvent for Suspension for Injection for Pigs

Active ingredient: Porcine respiratory and reproductive syndrome virus

Form

Injection

Species

Pigs

Manufacturer

Boehringer Ingelheim Vetmedica GmbH

VMD MA No.

61700/5001

What it's used for

Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces lung lesions, virus...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Prescription required

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Clinical information

Ingelvac PRRSFLEX EU Lyophilisate and Solvent for Suspension for Injection for Pigs — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

Under experimental challenge conditions in which only seronegative animals were
included, it was demonstrated that vaccination reduces lung lesions, virus load in
blood and lung tissues as well as negative effects of infection on daily weight gain. A
significant reduction of the respiratory clinical signs could additionally be
demonstrated at the onset of immunity.
Onset of immunity: 3 weeks.
Duration of immunity: 26 weeks.
Single injection of one dose (1 ml), irrespective of body weight.
For reconstitution, transfer the entire content of the solvent vial to the vial containing
the lyophilisate and reconstitute the lyophilisate as follows: 10 doses in 10 ml, 50
doses in 50 ml, 100 doses in 100 ml and 250 doses in 250 ml of the solvent.
Ensure that the lyophilisate is completely reconstituted before use.
Visual appearance after reconstitution: clear, colourless suspension.
Avoid introduction of contamination during use.
Use sterile equipment.
Avoid multiple broaching, for example by using automatic injectors.
When mixed with Ingelvac CircoFLEX:
•
•
When mixed with Ingelvac CircoFLEX the following equipment should be used:
•
•
• 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 section 5.5.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in breeding animals.
Do not use in PRRS naïve herds in which the presence of PRRSV has not been
established using reliable diagnostic methods.
Do not use in boars producing semen for naïve herds, as PRRSV can be shed in
semen.
Pigs:
Very common
(> 1 animal / 10 animals treated):
Elevated temperature
Uncommon
(1 to 10 animals / 1 000 animals
treated):
Injection site reaction (injection site
swelling, injection site reddening)
1
Slight increase not greater than 1.5 °C, return to normal without treatment, 1 to
3 days after the maximum temperature.
Minimal, disappears spontaneously without treatment.
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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
Vaccinate healthy animals only.
Maternally derived antibodies have been shown to interfere with vaccine efficacy. In
the presence of maternally derived antibodies, timing of initial vaccination of piglets
should be planned accordingly.

Special precautions for safe use in the target species:
The vaccine strain can spread to unvaccinated animals in contact with vaccinated
animals up to 3 weeks post vaccination. Special precautions should be taken to avoid
spreading of the vaccine strain within the herd, e.g. from positive to naïve animals.
Vaccinated animals may excrete the vaccine strain by faecal excretion and in some
cases by oral secretions.
Care should be taken to avoid spread of vaccine virus from vaccinated animals to
unvaccinated animals that should remain free from PRRS virus.
Vaccination should aim to achieve a homogenous immunity in the target population
at farm level. In the sow herd it is recommended to use a vaccine strain licensed for
use in sows.
Do not routinely rotate two or more commercial PRRS MLV vaccines based on
different strains in a herd. A PRRS vaccine based on the same strain (strain 94881)
and authorised for the immunisation of gilts and sows can be used on the same farm.
In order to limit the potential risk of recombination between PRRS MLV vaccine
strains of the same genotype, do not use different PRRS MLV vaccines based on
different strains of the same genotype on the same farm at the same time. In the
case of transitioning from one PRRS MLV vaccine to another PRRS MLV vaccine, a
transition period should be respected between the last administration of the current
vaccine and the first administration of the new vaccine. This transition period should
be longer than the shedding period of the current vaccine following vaccination.
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.
Safety and efficacy data are available which demonstrate that this vaccine can be
mixed with Boehringer Ingelheim’s Ingelvac CircoFLEX and administered at one
injection site.
The product literature of Ingelvac CircoFLEX should be consulted before
administration. 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.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Zero days.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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