INGELVAC PRRSFLEX EU 50ml

1. NAME OF THE MEDICINE FOR VETERINARY USE
Ingelvac PRRSFLEX ® EU lyophilized and solvent for injectable suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
Active substance:
Lyophilized:
Live attenuated Porcine Respiratory and Reproductive Syndrome virus (PRRSV), strain
94881(genotype 1): 10 4.4 -10 6.6 TCID 50 *
*infectious dose of 50% of tissue cultures
Excipients:
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Lyophilisate and solvent for injectable suspension
Freeze-dried: off-white to milky gray
Solvent: clear, colorless solution

4. CLINICAL FEATURES
4.1 Target species
Swine
4.2 Indications for use, specifying the target species, establishing immunity
For the active immunization of clinically healthy pigs, from at least 17 days of age until the end of the fattening period, from farms affected by European porcine reproductive and respiratory syndrome virus (PRRSV) (genotype 1), to reduce the viral load in the blood in seropositive animals under field conditions.
Under experimental infection conditions in which only seronegative animals were included, vaccination was shown to reduce lung lesions, viral load in blood and lung tissues, as well as the negative effects of infection on average daily gain. A significant reduction in respiratory clinical signs could be additionally demonstrated at the onset of immunity.
Onset of immunity: 3 weeks
Duration of immunity: 26 weeks
4.3 Contraindications
Do not use in known cases of hypersensitivity to the active substance or to any of
excipients.
Do not use for breeding animals.
It is not used for herds not previously exposed to PRRS, in which the presence of the PRRS virus does not a
has been established by reliable diagnostic methods.
4.4 Special precautions for each target species
Vaccinate only healthy animals.
Special precautions must be taken to avoid transmission of the vaccine strain in the herd, for example from positive animals to previously unexposed animals.
Do not use in boars producing semen for pig herds not exposed to the PRRS virus, as the virus can be shed in the semen.
Maternal antibodies have been shown to interfere with vaccine effectiveness. In the presence of maternal antibodies, the timing of the initial vaccination of piglets must be properly planned.

4.5 Special precautions for use
Special precautions for use in animals
The vaccine strain can be transmitted to unvaccinated animals that come into contact with vaccinated animals for up to 3 weeks after vaccination. Vaccinated animals can excrete the vaccine strain through faecal excretion and, in some cases, through oral secretions.
Precautions must be taken to avoid transmission of the vaccine virus from vaccinated animals to non-vaccinated animals, which must remain free of PRRS virus.
Vaccination should aim to achieve homogenous immunity of the target population at farm level. In the sow herd, it is recommended to use a vaccine strain approved for use in sows.
Do not routinely rotate in a herd two or more commercially available PRRS MLV vaccines based on different viral strains. A PRRS vaccine based on the same strain (strain 94881) and authorized for the immunization of young and adult sows can be used on the same farm.
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 viral strains of the same genotype on the same farm and at the same time. When switching from one PRRS MLV vaccine to another PRRS MLV vaccine, a transition period must be observed between the last administration of the current vaccine and the first administration of the new vaccine. This transition period should be longer than the propagation period of the current vaccine, which follows vaccination.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical attention immediately and show the package leaflet or label to the doctor.
4.6 Adverse reactions (frequency and severity)
After vaccination, a slight transient increase in body temperature (up to 1.5 °C) can be observed very frequently. Temperatures return to normal without further treatment, 1-3 days after the maximum temperature rise is recorded.
Injection site reactions are uncommon. Minimal and transient swelling or redness of the skin may be observed. These reactions disappear spontaneously, without any additional treatment.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 treated animals showing adverse reactions)
- Frequent (more than 1 but less than 10 animals out of 100 animals treated)
- Uncommon (more than 1 but less than 10 animals in 1000 animals treated)
- Rare (more than 1 but less than 10 animals out of 10,000 animals treated)
- Very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

4.7 Use during pregnancy, lactation or during the laying period
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
4.8 Interactions with other veterinary medicinal products and other forms of interaction
Safety and efficacy data are available to demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac CircoFLEX and administered at a single injection site.
Ingelvac CircoFLEX product documentation should be consulted prior to administration.
In some pigs the temperature rise after associated use rarely exceeds 1.5°C, but the rise remains below 2°C. The temperature returns to normal within 1 day after the temperature peak is noted. In rare cases, transient local reactions at the injection site, which are limited to a slight redness, may occur immediately after vaccination. Reactions disappear in less than a day. Immediate reactions such as mild hypersensitivity after vaccination were frequently observed, leading to transient clinical signs such as vomiting and rapid breathing, which disappeared within a few hours without
treatment. Purple coloration of the skin was observed in rare cases, which disappeared without treatment. Adequate precautions to minimize handling discomfort during product administration may reduce the frequency of hypersensitivity-type reactions.
There is no information available on the safety and efficacy of the vaccine when used with another veterinary medicinal product. The decision to use this vaccine before or after any other veterinary medicinal product will be made on a case-by-case basis.

4.9 Dose and route of administration
Intramuscular use.
Single intramuscular injection with one dose (1 ml), regardless of body weight.
For reconstitution, transfer the entire contents 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 solvent.
Ensure that the lyophilisate is completely reconstituted before use.
Visual appearance after reconstitution: clear, colorless suspension.
Avoid introducing sources of contamination during use.
Use sterile equipment.
Avoid repeatedly puncturing the rubber stopper, for example by using automatic syringes.
When mixing with Ingelvac CircoFLEX:
 Vaccinate only pigs from 17 days of age.
 It cannot be administered to pregnant or lactating sows.
When mixing with Ingelvac CircoFLEX, the following equipment must be used:
 Use the same volumes of Ingelvac CircoFLEX and Ingelvac PRRSFLEX EU.
Ingelvac CircoFLEX thus replaces PRRSFLEX EU solvent
 Use a pre-sterilized transfer needle. Pre-sterilized (CE certified) transfer needles are commonly available from medical equipment suppliers.
To ensure proper mixing, follow the steps below:
1. Plug one end of the transfer needle into the Ingelvac CircoFLEX vaccine vial.
2. Connect the opposite end of the transfer needle into the Ingelvac PRRSFLEX EU vaccine vial.
3. Transfer the contents of the Ingelvac CircoFLEX vaccine vial to the Ingelvac PRRSFLEX EU vaccine vial. If necessary, gently press the Ingelvac CircoFLEX vaccine vial to facilitate transfer.
After the entire contents of the Ingelvac CircoFLEX vaccine vial have been transferred, disconnect and discard the transfer needle and the empty Ingelvac CircoFLEX vaccine vial.

4. To ensure proper mixing of the vaccines, gently shake the Ingelvac PRRSFLEX vaccine vial until the powder is completely dissolved.
5. Intramuscularly administer a single injectable dose (1 ml) of the mixture to each pig, regardless of body weight. For administration, vaccination devices must
used in accordance with the device instructions provided by the manufacturer.
Use the entire vaccine mixture within 4 hours of mixing. Any unused mixture or waste should be disposed of in accordance with the instructions given in section 6.6.
4.10 Overdose (symptoms, emergency procedures, antidotes)
Regarding systemic and local reactions, no additional adverse effects were observed after administration of a 10-fold overdose in previously unexposed two-year-old piglets
weeks.
4.11 Waiting period
Zero days.

5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunological treatments for pigs, live virus vaccines for pigs.
Porcine respiratory and reproductive syndrome virus
ATC veterinary code: QI09AD03
The vaccine is designed to stimulate the development of an immune response in pigs with porcine reproductive and respiratory syndrome virus.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilized:
Sucrose
Gelatine
Potassium hydroxide
Glutamic acid
Potassium dihydrogen phosphate
Dipotassium phosphate
Sodium chloride
Solvent:
Phosphate buffer solution:
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product except the solvent provided for use with this veterinary medicinal product or Ingelvac CircoFLEX from Boehringer Ingelheim (both mixtures not indicated for use in pregnant or lactating sows).

6.3 Validity Period
Shelf life of the freeze-dried vaccine as packaged for sale: 2 years
Shelf life of the solvent as packaged for sale: 3 years
Shelf life after reconstitution with solvent according to the indications: 8 hours
6.4 Special conditions for storage
Store and transport under refrigerated conditions (2 °C - 8 °C).
Do not freeze.
Protect from light.

6.5 Nature and composition of primary packaging
Lyophilized: Type I glass vials, amber in color, with bromobutyl rubber stopper and aluminum seal.
Solvent: High density polyethylene (HDPE) bottles with bromobutyl or chlorobutyl rubber stopper and aluminum seal.
6.6 Special measures for the disposal of unused veterinary medicinal products or waste products derived from the use of such products
Any unused veterinary medicinal product or waste from the use of such products should be disposed of in accordance with local requirements.