SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ingelvac PRRSFLEX EU lyophilisate and Ingelvac PRRSFLEX EU solvent for suspension for injection for pigs

(BE, CY, DE, EL, FR, IT, LI, LU)

Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs

(AT, BG, CZ, EE, ES, HR, HU, IE, LT, LV, NL, PL, PT, RO, SI, SK, UK)

The name [the product] will be used in the Product Information

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (1 ml) contains:

Lyophilisate:

Active substance

Live attenuated Porcine Respiratory and Reproductive Syndrome Virus (PRRSV), strain 94881 (genotype 1)

At least: 10^4.4 TCID₅₀-10^6.6 TCID_50*

*Tissue Culture Infectious Dose50

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: off-white to milky-grey

Solvent: clear, colourless solution

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (from 17 days of age until the end of fattening)

4.2 Indications for use, specifying the target species

For active immunisation of clinically healthy pigs at 17 days of age and older from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce

virus load in blood in seropositive animals under field conditions.

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 additionaly be demonstrated at the onset of immunity.

Onset of immunity: 3 weeks

Duration of immunity: 26 weeks

4.3 Contraindications

Do not use in case 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.

4.4 Special warnings for each target species

Precautions should be taken to avoid the transfer of the vaccine virus within the herd, e.g. from positive animals to naïve animals.

Do not use in boars producing semen for naïve herds, as PRRSV can be shed in semen.

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.

4.5 Special precautions for use

Vaccinate only clinically healthy animals.

The vaccine strain may spread to unvaccinated animals in contact with vaccinated animals up to
3 weeks post vaccination. 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.

For optimum PRRS control programme, all animals in a herd should be vaccinated. In the sow herd it is recommended to use a vaccine licensed for use in sows.

In case adverse reactions develop following accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Very commonly, slight transient increases (not greater than 1.5°C) in body temperature can be observed following vaccination. Temperatures return to normal without additional treatment,
1 to 3 days after the maximum temperature increase is observed.

Injection site reactions are uncommon. Transient minimal 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 animals displaying adverse reactions during the course of one

treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation and lay

The safety of this veterinary medicinal product has not been established during pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

4.9 Amounts to be administered and administration route

Dosage and method of administration:

Single intramuscular 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.

Avoid introduction of contamination during use.

Use sterile equipment.

Avoid multiple broaching, for example by using automatic injectors.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No additional negative effects have been observed following the administration of a 10-fold overdose in naïve piglets of two weeks of age with regard to systemic and local reactions.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Porcine Reproductive and Respiratory Syndrome Virus

ATCvet code: QI09AD03

The vaccine is designed to stimulate the development of an immune response in pigs to Porcine Reproductive and Respiratory Syndrome Virus.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lyophilisate:

Sucrose

Gelatin

Potassium hydroxide

Glutamic acid

Potassium dihydrogen phosphate

Dipotassium phosphate

Sodium chloride

Solvent:

Phosphate buffered solution:

Sodium chloride

Potassium chloride

Potassium dihydrogen phosphate

Disodium hydrogen phosphate

Water for injection

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product except solvent supplied for use with the veterinary medicinal product.

6.3 Shelf life

Shelf life of the vaccine lyophilisate as packaged for sale: 1 year

Shelf life of the solvent as packaged for sale: 3 years

Shelf life after reconstitution according to directions: 8 hours

6.4 Special precautions for storage

Store and transport refrigerated (2 °C – 8 C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

Lyophilisate:

Type I amber glass vials with bromobutyl rubber stopper and aluminium seal.

Solvent:

High density polyethylene (HDPE) vials with bromo- or chlorobutyl rubber stopper and aluminium seal.

1 lyophilisate vial of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses) and 1 solvent vial of 10 ml, 50 ml, 100 ml or 250 ml packed in one cardboard box.

12 or 25 lyophilisate vials of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml
(250 doses) packed in a separate cardboard box.

12 or 25 solvent vials of 10 ml, 50 ml, 100 ml or 250 ml packed in a separate cardboard box.

Not all package sizes may be marketed.

6.6 Special precautions for the disposal of unused medicinal product or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

8. MARKETING AUTHORISATION NUMBER

Vm 00015/4090

9. DATE OF AUTHORISATION

March 2015

10. DATE OF REVISION OF THE TEXT

September 2015

Approved: 08/09/2015