Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Porcine parvovirus, strain 27a, viral protein 2
Boehringer Ingelheim Vetmedica GmbH
QI09AA02
porcine parvovirosis vaccine (inactivated)
Pigs
Immunologicals for suidae
For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
Revision: 1
Authorised
2019-04-26
15 B. PACKAGE LEAFLET 16 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. 4. INDICATION(S) 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). 17 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 Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ReproCyc ParvoFLEX suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: ACTIVE SUBSTANCE: Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* * Relative Potency (ELISA) ADJUVANT: Carbomer 2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Colourless to slightly brown, opalescent suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE 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. 3 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) 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 reaction(s)) - 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). 4.7 USE DURING PREGNANCY, LACTATION AND LAY Can be used during pregnancy and lactation. 4.8 INT Leggi il documento completo