Colourless to slightly brown, opalescent suspension for injection.

Each dose (2 ml) contains : Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* (*Relative Potency - ELISA).

Adjuvant : carbomer 2 mg.

For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.

Onset of immunity: from the beginning of the gestational period.

Duration of immunity: 6 months.

Shake well before use. Avoid introduction of contamination during use.

For pigs previously non-vaccinated against porcine parvovirus:

Two intramuscular injections of one dose, 3 weeks apart. The second dose being given at least 3 weeks before mating.

One intramuscular injection of one dose at least every 6 months is recommended in a whole herd programme (see "Uses" section).

The full content of one vial of ReproCyc ParvoFLEX should be used to reconstitute the lyophilisate of one vial of ReproCyc PRRS EU. ReproCyc ParvoFLEX hereby replaces the solvent of ReproCyc PRRS EU.

Ensure that the lyophilisate is completely reconstituted before use.

Administer a single dose (2 ml) of the mixture intramuscularly.

The following corresponding presentations (doses) can be mixed:

ReproCyc ParvoFLEX	ReproCyc PRRS EU (lyophilisate)
10 doses (20 ml)	10 doses
50 doses (100 ml)	50 doses
100 doses (200 ml)	100 doses

The package leaflet of ReproCyc PRRS EU should also be consulted before the administration of the mixed product.

Vaccinate healthy animals only.

Transient redness or swelling (up to 4 cm) caused by the injection procedure is very common. Local reactions resolve within two to five days without treatment. An elevation in the body temperature after vaccination is common which resolves spontaneously within 24 to 48 hours.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions)

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

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

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

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

Can be used during pregnancy and lactation.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim’s ReproCyc PRRS EU and administered at one injection site.

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.

Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s ReproCyc PRRS EU.

Zero days

Keep out of the reach and sight of children. For animal treatment only - to be supplied only on veterinary prescription.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 8 hours.

Shelf life after mixing with ReproCyc PRRS EU: 8 hours.

Store and transport refrigerated (2°C - 8°C). Do not freeze. Keep the bottle in the outer carton in order to protect from light.

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

Pack sizes of 1 or 12 high density polyethylene bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses). Each bottle is closed with a rubber stopper and an aluminium cap. Not all pack sizes may be marketed.

This vaccine is designed to stimulate the development of an active immune response in pigs to porcine parvovirus.

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

GERMANY

UK(GB): Vm 04491/5057

UK(NI): EU/2/19/237/001-006