Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus
Novartis Animal Vaccines Ltd
QI10AA01
Aeromonas salmonicida subsp. salmonicida, Infectious pancreatic necrosis virus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Salmon (Atlantic)
Inactivated Viral and Bacterial Vaccine
Expired
2007-06-22
Revised: May 2013 AN: 00228/2013 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Birnagen Forte As Emulsion for Injection for Atlantic Salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES 1 dose (0.1 ml) contains: Inactivated _Aeromonas salmonicida_ (As27) RPS 60 * ≥80% Inactivated Infectious Pancreatic Necrosis RP** ≥ 1.22 Virus (IPNV) * RPS 60 : Relative Percent Survival ** RP: relative potency compared to a reference vaccine. ADJUVANT Mineral oil (Drakeol 6VR) 43.62% EXCIPIENTS Formaldehyde (residual inactivant) < 0.5% (w/v) See section 6.1 for a complete list of excipients 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Atlantic salmon (_Salmo salar_) weighing at least 35 g. 4.2 INDICATIONS FOR USE For the active immunisation of Atlantic salmon (_Salmo salar_) to prevent mortality due to infection with _Aeromonas salmonicida_ (furunculosis). The onset of immunity to _A. salmonicida_ is no later than 430 degree days following vaccination. The duration of immunity to _A. salmonicida_ has been demonstrated up to 2000 degree days following vaccination. Revised: May 2013 AN: 00228/2013 Page 2 of 5 For the active immunisation of Atlantic salmon to reduce clinical signs and mortality due to infection with Infectious Pancreatic Necrosis Virus (IPNV). In laboratory trials, the onset of immunity to IPNV has been shown to be no later than 771 degree days following vaccination. In field trials, the vaccine has been shown to reduce mortality compared to controls in the face of IPNV challenge after transfer to sea 600 degree days after vaccination. 4.3 CONTRAINDICATIONS Do not use if there are any signs of furunculosis or IPNV disease in the fish. See section 4.7. 4.4 SPECIAL WARNINGS Vaccinate only healthy fish. It is recommended that all fish within the stock population are vaccinated in order to reduce infection spread. Fish should be starved for a period of at least 24 hours and preferably 48 hours prior to vaccinat Read the complete document