국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein, Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
Zoetis Belgium SA
QI09AL
Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Pigs
Inactivated viral and inactivated bacterial vaccines
For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.For active immunisation of pigs over the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
Revision: 7
Authorised
2015-11-06
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: SUVAXYN CIRCO+MH RTU 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 authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo+MH RTU emulsion for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (2 ml) contains: ACTIVE SUBSTANCES: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein Inactivated _Mycoplasma hyopneumoniae, _ strain P-5722-3 _ _ 2.3 – 12.4 RP* 1.5 – 3.8 RP* ADJUVANT: Squalane Poloxamer 401 Polysorbate 80 0.4% (v/v) 0.2% (v/v) 0.032% (v/v) EXCIPIENTS: Thiomersal 0.2 mg * Relative potency unit determined by ELISA antigen quantification ( _in vitro _ potency test) compared to a reference vaccine. White homogenous emulsion. 4. INDICATION(S) For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2. For active immunization of pigs from 3 weeks of age against _Mycoplasma hyopneumoniae _ to reduce lung lesions caused by infection with _M. hyopneumoniae_ . Onset of immunity: 3 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. 17 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient increase in body temperature (on average 1 °C) was very commonly observed during the first 24 hours after vaccination in laboratory and field trials. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. This resolves spontaneously within 48 hours without treatment. Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpatio 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo+MH RTU emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: ACTIVE SUBSTANCES: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein Inactivated _Mycoplasma hyopneumoniae, _ strain P-5722-3 _ _ 2.3 – 12.4 RP* 1.5 – 3.8 RP* ADJUVANT: Squalane Poloxamer 401 Polysorbate 80 EXCIPIENTS: 0.4% (v/v) 0.2% (v/v) 0.032% (v/v) Thiomersal 0.2 mg * Relative potency unit determined by ELISA antigen quantification ( _in vitro _ potency test) compared to a reference vaccine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. White homogenous emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (for fattening). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2. For active immunization of pigs from the age of 3 weeks against _Mycoplasma hyopneumoniae _ to reduce lung lesions caused by infection with _M. hyopneumoniae_ . Onset of immunity: 3 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. 4.3 CONTRAINDICATIONS None. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars. 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 transient increase in body temperature (on average 1 °C) was very commonly observed during the firs 전체 문서 읽기