ReproCyc ParvoFLEX - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

ReproCyc ParvoFLEX suspension for injection for pigs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

ReproCyc ParvoFLEX suspension for injection for pigs

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

Each dose (2 ml) contains:

Porcine Parvovirus strain 27a VP2 subunit antigen: > 1.0 RP

Relative potency (ELISA).

Adjuvant: Carbomer 2 mg.

Colourless to slightly brown, opalescent suspension for injection.

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

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

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).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Pigs

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Primary vaccination scheme:

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.

Re-vaccination scheme:

One intramuscular injection of one dose at least every six months is recommended in a whole herd programme (see section “Indications”).

Mixing with ReproCyc PRRS EU:

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.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

Avoid introduction of contamination during use.

• 10. WITHDRAWAL PERIOD(S)

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C-8 °C).

Do not freeze.

Keep the bottle in the outer carton in order to p rotect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after ‘EXP’.

Shelf life after first opening of the bottle: use within 8 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

Special precautions for use in animals:

Not applicable.

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

Not applicable.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction:

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with 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.

Overdose (symptoms, emergency procedures, antidotes):

No data available.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION