מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Salmon pancreas disease virus
MSD Animal Health UK Limited
QI10AL
Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus, Salmon pancreas disease virus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Atlantic salmon
Inactivated Viral and Bacterial Vaccine
Authorized
2015-03-26
Amended pages: October 2023 AN: 01481/2023 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AquaVac PD3 emulsion for injection, for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.1 ml vaccine: ACTIVE SUBSTANCE(S): Salmon pancreas disease virus (SPDV) strain F93-125, ≥ 75% RPP 1 Infectious pancreatic necrosis virus (IPNV), ≥ 1.5 ELISA units 2 _Aeromonas salmonicida_ subsp. _salmonicida_, ≥ 80% RPS 60 3 1 RPP: relative percentage protection in a laboratory test in Atlantic salmon 2 Antigenic mass measured in the final product 3 RPS: relative percentage survival at 60% control mortality in a laboratory test in Atlantic salmon ADJUVANT: Light liquid paraffin, 43 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. White to nearly white emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Atlantic salmon (_Salmo salar_ L). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of Atlantic salmon to reduce clinical signs (heart lesions and pancreas lesions), viremia, viral shedding and mortality from infection with SPDV (Pancreas disease) and to reduce mortality from infections with IPNV (Infectious pancreatic necrosis) and _Aeromonas salmonicida_ subsp. _salmonicida_ (furunculosis). Onset of immunity: 500 degree days after vaccination for SPDV and _Aeromonas _ _salmonicida_ and 540 degree days after vaccination for IPNV. Duration of immunity: demonstrated at 15 months post vaccination for SPDV and at 16 months post vaccination for _Aeromonas salmonicida_. Protection against mortality Amended pages: October 2023 AN: 01481/2023 Page 2 of 5 due to IPNV infection has been demonstrated at 4 months post vaccination in the field. 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 Do not use in fish during smoltification. Incorrect vaccination, stress and poor קרא את המסמך השלם