SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ReproCyc PRRS EU lyophilisate and ImpranFLEX solvent for suspension for injection for pigs (BE, CY, DE, EL, FR, LI, LU)

ReproCyc PRRS 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)

ReproCyc PRRS EU lyophilisate and ReproCyc PRRS EU solvent for suspension for injection for pigs (IT)

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) contains:

Lyophilisate:

Active substance

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

At least: 10^3.9 TCID_50-10^7.0 TCID_50*

*Tissue Culture Infectious Dose 50

Solvent:

Adjuvant

Carbomer: 2.0 mg

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 (breeding females)

4.2 Indications for use, specifying the target species

For active immunisation of breeding females from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce the duration of viraemia, the proportion of viraemic gilts/sows and viral loads in blood after exposure to PRRSV as shown under experimental conditions.

Onset of immunity: 5 weeks

Duration of immunity: 17 weeks

Vaccination of breeding females according to the recommended schedule described in section 4.9 reduces the negative reproductive disorders associated with PRRSV.

Under experimental challenge conditions a reduction in transplacental virus transmission after challenge was additionally demonstrated. In piglets from vaccinated sows, a reduction in the negative impact of PRRS virus infection (mortality, clinical signs and weight gain) was also demonstrated during the first 20 days of life.

4.3 Contraindications

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

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

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.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only clinically healthy animals.

The vaccine strain may spread up to 5 weeks after vaccination to unvaccinated animals in contact but without any clinical consequence. Vaccinated animals may excrete the vaccine strain by faecal excretion.The potential excretion of the vaccine strain in the urine of vaccinated animals has not been investigated.

The vaccine strain has been detected in new-born piglets (blood, lung samples) when vaccinating naïve gilts during last third of gestation but without any clinical consequence.

Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals that should remain free from PRRSV.

It is advised to vaccinate all breeding females within a herd. Newly introduced PRRSV-naïve females (e.g. replacement females from PRRSV-negative herds) should be vaccinated prior to pregnancy.

For optimal PRRSV control programme, all animals in a herd should be vaccinated.

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

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)

A transient increase in body temperature (up to 2°C above the physiological range) commonly occurs up to 5 days post-vaccination. Temperatures return to the normal range without additional treatment, 1 to 4 days after the maximum temperature increase is observed.

Commonly, reduced appetite may be observed after vaccination.

Uncommonly, recumbency and accelerated breathing can be observed on the day of vaccination. These signs disappear spontaneously without any treatment.

Commonly, very minimal swelling or redness of the skin at the injection site may be observed. These reactions (up to 8cm but typically < 2 cm in size) are transient and subside within a short time (maximum of 5 days but typically less than 2 days) without 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

Can be used during pregnancy and lactation.

PRRSV naïve gilts should not be vaccinated during pregnancy.

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 (2 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 20 ml, 50 doses in 100 ml and 100 doses in 200 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.

Regime of vaccination:

Gilts: for protection against PRRSV during pregnancy vaccination is recommended before integration into the sow herd between 2 and 5 weeks prior to breeding. Gilts can then be subjected to the same vaccination programme as the sow herd.

Sows: mass vaccination is recommended in a whole herd programme, in which all the pregnant and non-pregnant sows in the herd are vaccinated every three to four months.

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

No adverse events other than those listed in section 4.6 for a single dose were observed following a 10-fold overdose administration.

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

Carbomer

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: 15 months

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

Shelf life after reconstitution according to directions: 4 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 a bromo- or chlorobutyl rubber stopper and aluminium seal.

1 lyophilisate vial of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) and 1 solvent vial of

20 ml, 100 ml or 200 ml packed in one cardboard box.

12 or 25 lyophilisate vials of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a separate cardboard box.

12 or 25 solvent vials of 20 ml, 100 ml or 200 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

Vm00015/4089

9. DATE OF AUTHORISATION

26 March 2015

10. DATE OF REVISION OF THE TEXT

September 2015

Approved: 22 September 2015