Land: Storbritannien
Sprog: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Porcine circovirus-2
Zoetis UK Limited
QI09AA07
Porcine circovirus-2
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Viral Vaccine
Authorized
2018-02-07
Unlimited Renewal: February 2023 AN: 03397/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 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 Unlimited Renewal: February 2023 AN: 03397/2022 Page 2 of 5 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 None 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) 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 reacti Læs hele dokumentet