Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
porcine circovirus type 2 ORF2 protein
Boehringer Ingelheim Vetmedica GmbH
QI09AA07
inactivated porcine circovirus vaccine
Pigs
Immunologicals for suidae
For active immunisation of pigs over the age of two weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - 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 protection occurs as early as two weeks post vaccination and lasts for at least 17 weeks.
Revision: 16
Authorised
2008-02-13
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INGELVAC CIRCOFLEX 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 CircoFLEX 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 Clear to slightly opalescent, colourless to yellowish suspension for injection. 4. INDICATIONS For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - 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) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 19 If you notice any side effects, even those not already listed in this package leaflet Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac CircoFLEX 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 EXCIPIENTS: 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 from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - 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 In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 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 reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but Przeczytaj cały dokument