Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
porcine circovirus type 2 ORF2 subunit antigen
Intervet International B.V.
QI09AA07
Porcine circovirus vaccine (inactivated)
Pigs
Immunologicals for suidae, Inactivated viral vaccines
For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection.
Revision: 3
Authorised
2015-08-28
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: Porcilis PCV ID emulsion 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: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 0.2 ml contains: ACTIVE SUBSTANCE: Porcine circovirus type 2 ORF2 subunit antigen ≥ 1436 AU 1 ADJUVANTS: dl-α-tocopheryl acetate 0.6 mg Light liquid paraffin 8.3 mg 1 Antigenic units as determined in the _in vitro_ antigenic mass assay. Emulsion for injection. Homogenous, white to nearly white emulsion after shaking. 4. INDICATION(S) For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection. Onset of immunity: 2 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Transient local reactions mostly consisting of hard non-painful swellings of up to 2 cm diameter were very commonly observed in laboratory studies and field trials. A biphasic pattern of the local 16 reactions, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed. In individual pigs the size may increase to 6.5 cm and redness and/or scabs may be observed. The local reactions disappear completely within approximately7 weeks after vaccination. 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 th Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains: ACTIVE SUBSTANCE: Porcine circovirus type 2 ORF2 subunit antigen ≥ 1436 AU 1 ADJUVANTS: dl-α-tocopheryl acetate 0.6 mg Light liquid paraffin 8.3 mg 1 Antigenic units as determined in the _in vitro_ potency test (antigenic mass assay). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Homogenous, white to nearly white emulsion after shaking. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection. Onset of immunity: 2 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. 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 Use of the vaccine in boars has not been evaluated. Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: 3 This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidenta Pročitajte cijeli dokument