Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
porcine circovirus vaccine (inactivated, recombinant)
Zoetis Belgium SA
QI09AA07
porcine circovirus vaccine (inactivated, recombinant)
Pigs (for fattening)
Immunologicals for suidae, Inactivated viral 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.,
Revision: 2
Authorised
2018-02-07
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: SUVAXYN CIRCO 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 emulsion for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (2 ml) contains: ACTIVE SUBSTANCES: Inactivated recombinant chimeric porcine circovirus type 1containing the porcine circovirus type 2 ORF2 protein 2.3 – 12.4 RP* ADJUVANT: Squalane Poloxamer 401 Polysorbate 80 8 µl (0.4% v/v) 4 µl (0.2% v/v) 0.64 µl (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. Onset of immunity: from 3 weeks after vaccination. Duration of immunity: 23weeks after vaccination 5. CONTRAINDICATIONS None. 17 6. ADVERSE REACTIONS A transient increase in body temperature (on average 1 °C) is very common during the first 24 hours after vaccination. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. This resolves spontaneously within 48 hours without treatment. Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rare cases. In case of such reactions, appropriate treatment is recommended. Local tissue reactions in the form of swelling at the injection site, which m Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: ACTIVE SUBSTANCE: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein _ _ 2.3 – 12.4 RP* ADJUVANT: Squalane Poloxamer 401 Polysorbate 80 EXCIPIENTS: 8 µl (0.4% v/v) 4 µl (0.2% v/v) 0.64 µl (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. Onset of immunity: from 3 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. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A transient increase in body temperature (on average 1°C) is very common during the first 24 hours after vaccination. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. This resolves spontaneously within 48 hours without treatment. Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rar Aqra d-dokument sħiħ