Clynav
Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Foglio illustrativo
(PIL)
25-09-2020
Scheda tecnica
(SPC)
25-09-2020
Relazione pubblica di valutazione
(PAR)
25-09-2020
Principio attivo:
pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
Commercializzato da:
Elanco GmbH
Codice ATC:
QI10AX
INN (Nome Internazionale):
Salmon pancreas disease vaccine (recombinant DNA plasmid)
Gruppo terapeutico:
Atlantic salmon
Area terapeutica:
Immunologicals for Atlantic salmon,
Indicazioni terapeutiche:
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).
Dettagli prodotto:
Revision: 5
Stato dell'autorizzazione:
Authorised
Data dell'autorizzazione:
2017-06-26
Foglio illustrativo
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
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Scheda tecnica
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
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