מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
infectious pancreatic necrosis virus, inactivated; Listonella anguillarum serotype o2a; al 104; Listonella anguillarum serotype O1; AL 112; Aeromonas salmonicida subsp. salmonicida, al 2017; Moritella viscosa, al 266; Vibrio salmonicida al 1134
PHARMAQ AS
QI10AL02
infectious pancreatic necrosis virus, inactivated; Listonella anguillarum serotype o2a; al 104; Listonella anguillarum serotype O1; AL 112; Aeromonas salmonicida subsp. salmonicida, al 2017; Moritella viscosa, al 266; Vibrio salmonicida al 1134
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Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
infectious pancreatic necrosis (IPN) virus + aeromonas + moritella + vibrio
Authorised
2019-03-15
1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALPHA JECT micro 6 emulsion for injection for Atlantic salmon. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.05 ml) contains: ACTIVE SUBSTANCES: Formaldehyde inactivated cultures of: _Aeromonas salmonicida _ subsp. _salmonicida _ > 12.6 log 2 ELISA units _Listonella anguillarum_ * serotype O1 RPS ≥ 75 % _Listonella anguillarum_ * serotype O2a RPS ≥ 75 % _Vibrio salmonicida _ RPS ≥ 90 % _Moritella viscosa _ > 10.7 log 2 ELISA units Infectious Pancreatic Necrosis Virus serotype Sp 0.12-0.28 AU ELISA units: Serological response in Atlantic salmon, RPS: Relative Percentage Survival is based on results from challenge studies on Atlantic salmon at 60% mortality in the control group. AU: Antigenicity Units (quantity of virus antigen measured in the final product). * _Listonella anguilllarum _ is synonymous with _Vibrio anguillarum._ ADJUVANT: Paraffin, light liquid (mineral oil): 23 mg. EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. White to cream coloured. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Atlantic salmon ( _Salmo salar_ ) of a minimum weight of 25 g. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of Atlantic salmon to reduce mortality caused by infections with _Aeromonas _ _salmonicida _ (furunculosis), _Vibrio salmonicida _ (coldwater vibriosis), _Listonella anguillarum _ serotype O1and O2a (classical vibriosis), _Moritella viscosa _ (winter sore) and IPNV (infectious pancreatic necrosis). Onset of immunity: 520 degree days post vaccination for the bacterial antigens and 600 degree days post vaccination for IPNV. Duration of immunity: 12 months for the bacterial antigens and 5.5 months for IPNV. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy fish only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccination should preferably be performed at water temperatures of 15°C or below. Do not vacc קרא את המסמך השלם