Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
porcine circovirus type 2 ORF2 protein
Boehringer Ingelheim Vetmedica GmbH
QI09AA07
Porcine circovirus vaccine (inactivated)
Pigs
Immunologicals for suidae
For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2),
Revision: 2
Withdrawn
2017-05-24
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INGELVAC PCV FLEX 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 Ingelvac PCV FLEX suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein: RP* 1.0–3.75 * Relative potency (ELISA test) by comparison with a reference vaccine. Adjuvant: Carbomer 1 mg. Clear to slightly opalescent, colourless to yellowish suspension for injection. 4. INDICATIONS For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2). Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia. Onset of immunity: 2 weeks post vaccination Duration of immunity: at least 17 weeks. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A mild and transient hyperthermia very commonly occurs on the day of vaccination. On very rare occasions anaphylactic reactions may occur and should be treated symptomatically. 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) 18 - very rare (less than 1 Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac PCV FLEX suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (1 ml) contains: ACTIVE SUBSTANCE: Porcine circovirus type 2 ORF2 protein RP* 1.0–3.75 * Relative potency (ELISA test) by comparison with a reference vaccine ADJUVANT: Carbomer 1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear to slightly opalescent, colourless to yellowish suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2). Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs and lesions in lymphoid tissues associated with PCV2 related disease (PCVD). In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia. Onset of immunity: 2 weeks post vaccination Duration of immunity: at least 17 weeks. 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. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A mild and transient hyperthermia very commonly occurs on the day of vaccination. On very rare occasions anaphylactic reactions may occur and should be treated symptomatically. 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 (m Aqra d-dokument sħiħ