Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
Elanco GmbH
QI10AX
Salmon pancreas disease vaccine (recombinant DNA plasmid)
Atlantic salmon
Immunologicals for Atlantic salmon,
For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3).
Revision: 5
Authorised
2017-06-26
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: CLYNAV solution for injection for Atlantic salmon 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Straβe 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4 27472 Cuxhaven Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 0.05 ml dose contains: ACTIVE SUBSTANCE: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 6.0– 9.4 μg. 4. INDICATION(S) For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3). Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination. Duration of immunity: 1 year for reduction in impaired daily weight gain, and cardiac, pancreatic and skeletal muscle lesions and 9.5 months for reduction of mortality (demonstrated in a laboratory efficacy study in saltwater conditions using a cohabitation challenge model). 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be observed for up to 2, 7 and 9 days, respectively. Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and 15 microscopically. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.05 ml dose contains: ACTIVE SUBSTANCE: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 6.0 – 9.4 μg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear, colourless, particulate-free solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Atlantic salmon ( _Salmo salar_ ). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3). Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination. Duration of immunity: 1 year for reduction in impaired daily weight gain, and cardiac, pancreatic and skeletal muscle lesions and 9.5 months for reduction of mortality (demonstrated in a laboratory efficacy study in saltwater conditions using a cohabitation challenge model). 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 A minimum body weight of 25 g is recommended at vaccination. 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Personal protective equipment, for example, consisting of appropriate protective gloves, should be worn when handling the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be obser Aqra d-dokument sħiħ