Country: European Union
Language: English
Source: EMA (European Medicines Agency)
inactivated porcine circovirus type 2 (PCV2)
CEVA-Phylaxia Oltóanyagtermelõ Zrt.
QI09AA07
adjuvanted inactivated vaccine against porcine circovirus type 2
Pigs (gilts and sows)
Immunologicals for suidae
Sows and giltsPassive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality.PigletsActive immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality, as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.
Revision: 12
Authorised
2007-06-21
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET FOR: CIRCOVAC EMULSION AND SUSPENSION FOR 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: CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5., Budapest, 1107, Hungary Manufacturer for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5., Budapest, 1107, Hungary 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Circovac Emulsion and suspension for emulsion for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Pale opalescent liquid prior to reconstitution Each ml of reconstituted vaccine contains: ACTIVE SUBSTANCE: Inactivated porcine circovirus type 2 (PCV2) ................................................. 1.8 log10 ELISA Units EXCIPIENT: Thiomersal ................................................................................................................................... 0.10 mg ADJUVANT: Light paraffin oil ............................................................................................................ 247 to 250.5 mg 4. INDICATION(S) PIGLETS : Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2 linked clinical signs, including wasting, weight loss and mortality as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection. Onset of immunity: 2 weeks. Duration of immunity: at least 14 weeks after vaccination. SOWS AND GILTS: Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality. Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake. 5. CONTRAINDI Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Circovac emulsion and suspension for emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of reconstituted vaccine contains: ACTIVE SUBSTANCE: Inactivated porcine circovirus type 2 (PCV2) ................................................. 1.8 log10 ELISA Units EXCIPIENT: Thiomersal ................................................................................................................................... 0.10 mg ADJUVANT: Light paraffin oil ............................................................................................................ 247 to 250.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion and suspension for emulsion for injection. Pale opalescent liquid prior to reconstitution. The reconstituted vaccine is a homogeneous white emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (gilts, sows and piglets from 3 weeks of age). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES PIGLETS : Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection. Onset of immunity: 2 weeks Duration of immunity: at least 14 weeks after vaccination. SOWS AND GILTS : Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality. Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake. 4.3 CONTRAINDICATIONS None. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Sows: None. Piglets: The efficacy of the vaccine in the face of intermediate to high levels of maternally derived antibodies has been demonstrated. 4.5 SPECIAL PRECAUTIONS FOR USE SPE Read the complete document