Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
porcine circovirus type 2 ORF2 subunit antigen
Intervet International BV
QI09AA07
adjuvanted inactivated vaccine against porcine circovirus
Pigs
Immunologicals for suidae
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with porcine-circovirus-type-2 infection occurring during the fattening period.Onset of immunity: 2 weeksDuration of immunity: 22 weeks
Revision: 7
Authorised
2009-01-12
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: Porcilis PCV 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 BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 2 ml contains: Porcine circovirus type 2 ORF2 subunit antigen: ≥ 3720 Antigenic Units as determined in the in vitro potency test (AlphaLISA) Adjuvants: 25 mg dl-α-tocopheryl acetate 346 mg light liquid paraffin. Emulsion for injection. Opalescent white, with brown resuspendable sediment. 4. INDICATION(S) For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period. Onset of immunity: 2 weeks Duration of immunity: 22 weeks. 5. CONTRAINDICATIONS None 6. ADVERSE REACTIONS In laboratory studies and field trials: Transient local reactions at the injection site were very commonly observed after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14–21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivity-like reactions were commonly observed after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days 18 after vaccination. In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed. I Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: Active substance: Porcine circovirus type 2 ORF2 subunit antigen: ≥3720 AU* * Antigenic Units as determined in the in vitro potency test (AlphaLISA). Adjuvants: Dl-α-tocopheryl acetate 25 mg Light liquid paraffin 346 mg Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Opalescent white, with brown resuspendable sediment. 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 the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period. Onset of immunity: 2 weeks Duration of immunity: 22 weeks. 4.3 Contraindications None 4.4 Special warnings for each target species From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets. No data are available on the use of the vaccine in breeding boars. 4.5 Special precautions for use Special precautions for use in animals 3 Vaccinate only healthy animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: 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 insert with you. If pain persists for more than 12 hours after medical exam Przeczytaj cały dokument