מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Porcine circovirus-2
MSD Animal Health UK Limited
QI09AA07
Porcine circovirus-2
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Viral Vaccine
Authorized
2009-01-12
Revised: April 2024 AN: 00332/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCE: Porcine circovirus type 2 ORF2 subunit antigen: ≥ 3720 AU* *Antigenic Units as determined in the in vitro potency test (AlphaLISA) ADJUVANTS: Dl-α-tocopheryl acetate 25 mg Light liquid paraffin 346 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Opalescent white, with brown resuspendable sediment. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period. Onset of immunity: 2 weeks. Duration of immunity: 22 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Revised: April 2024 AN: 00332/2023 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets. No data are available on the use of the vaccine in breeding boars. Special precautions to be taken by the person administering the veterinary medicinal product to animals: To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self- injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is in קרא את המסמך השלם