البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida; Vibrio anguillarum, serotype O1, Inactivated; Vibrio anguillarum, serotype O2A, Inactivated; Moritella Viscosa, inactivated; Vibrio Salmonicida, inactivated
Intervet Ireland Limited
QI10AL02
Inactivated infectious pancreatic necrosis virus; Inactivated aeromonas salmonicida subsp. salmonicida; Vibrio anguillarum, serotype O1, Inactivated; Vibrio anguillarum, serotype O2A, Inactivated; Moritella Viscosa, inactivated; Vibrio Salmonicida, inactivated
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
infectious pancreatic necrosis (IPN) virus + aeromonas + moritella + vibrio
2022-06-24
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AquaVac 6 emulsion for injection for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.1 ml dose contains: ACTIVE SUBSTANCES: Infectious pancreatic necrosis virus (IPNV) serotype Sp, inactivated ≥ 1.5 ELISA units 1 _Aeromonas salmonicida _ subsp. s _almonicida_ , inactivated ≥ 10.7 log 2 ELISA units 2 _Vibrio salmonicida, _ inactivated ≥ 90% RPS 3 _Listonella (Vibrio) anguillarum _ serotype O1, inactivated ≥ 75% RPS 3 _Listonella (Vibrio) anguillarum _ serotype O2a, inactivated ≥ 75% RPS 3 _Moritella viscosa_ , inactivated ≥ 6.5 log 2 ELISA units 2 1 Antigenic mass measured in the final product 2 Serological response in Atlantic salmon 3 RPS: relative percentage survival in a laboratory test in Atlantic salmon ADJUVANT: Paraffin, light liquid 43 mg. EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Polysorbate 80 Sorbitan monooleate Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections White to nearly white emulsion. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Atlantic salmon ( _Salmo salar _ L). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For active immunisation of Atlantic salmon to reduce mortality caused by infections with IPNV (Infectious pancreatic necrosis), _Aeromonas salmonicida _ subsp. _salmonicida _ (furunculosis), _Vibrio _ _salmonicida _ (cold-water vibriosis), _Listonella (Vibrio) anguillarum _ serotype O1 and O2a (vibriosis), and _Moritella viscosa _ (winter ulcer disease). Onset of immunity: 500 degree days after vaccination for the bacterial antigens and 608 degree days after vaccination for IPNV. Duration of immunity: _A. salmonicida _ and _M. viscosa_ : 18 months, _L. anguillarum O1_ , _L. anguillarum O2a _ and _V. salmonicida_ : 16 months, 2 Infectious pancreatic necrosis virus: 4 months. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS Vaccinate healthy fish only. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in اقرأ الوثيقة كاملة