Negara: Inggris
Bahasa: Inggris
Sumber: 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
2015-08-28
Amended pages: October 2023 AN: 00940/2022 & 01210/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains: Porcine circovirus type 2 ORF2 subunit antigen 1436 AU 1 ADJUVANTS: dl-α-tocopheryl acetate 0.6 mg Light liquid paraffin 8.3 mg 1 Antigenic units as determined in the _in vitro_ potency test (antigenic mass assay). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Homogenous, white to nearly white emulsion after shaking. 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 viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection. Onset of immunity: 2 weeks after vaccination. Duration of immunity: 23 weeks after vaccination. 4.3 CONTRAINDICATIONS None. Amended pages: October 2023 AN: 00940/2022 & 01210/2022 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use of the vaccine in boars has not been evaluated. 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 product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. To the physician: Th Baca dokumen lengkapnya