Clynav (pUK-SPDV-poly2#1 DNA plasmid coding...) – Package leaflet - QI10AX
Updated on site: 09-Feb-2018
|Efni:||pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins|
|Framleiðandi:||Elanco Europe Limited|
- 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
- 2. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
- 4. INDICATION(S)
- 5. CONTRAINDICATIONS
- 6. ADVERSE REACTIONS
- 7. TARGET SPECIES
- 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
- 9. ADVICE ON CORRECT ADMINISTRATION
- 10. WITHDRAWAL PERIOD
- 11. SPECIAL STORAGE PRECAUTIONS
- 12. SPECIAL WARNING(S)
- 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
- 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
- 15. OTHER INFORMATION
PACKAGE LEAFLET FOR:
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 Europe Ltd.
Hampshire, RG24 9NL
Manufacturer responsible for batch release:
Elanco Animal Health
Eli Lilly and Company Limited, Speke Operations
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:
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 is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).
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 microscopically.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
-common (more than 1 but less than 10 animals in 100 animals)
-uncommon (more than 1 but less than 10 animals in 1,000 animals )
-rare (more than 1 but less than 10 animals in 10,000 animals)
-very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Atlantic salmon (Salmo salar).
8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle.
9.ADVICE ON CORRECT ADMINISTRATION
Shake product gently before use.
Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place. Connect the other end of the transfer tubing set to the vaccine injection equipment (gun).
Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the
Zero degree days.
11.SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
Special warnings for the target species
Do not use in clinically diseased groups of fish.
Only healthy fish should be vaccinated. A minimum body weight of 25 g is recommended at vaccination.
The effect of vaccine on reproductive performance has not been investigated. Do not use in broodstock.
No effects other than those described in section 6 have been observed following the administration of an overdose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment, for example, appropriate protective gloves, should be worn when handling the veterinary product.
In case of accidental
Interactions with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
CLYNAV stimulates active immunity against salmonid alphavirus subtype 3 (SAV3).
CLYNAV contains a supercoiled DNA plasmid which expresses proteins of salmon alphavirus which induces a protective immune response in vaccinated Atlantic salmon.
250 ml sterile, flexible, ethyl vinyl acetate (EVA) bags with a locking snap down port. A sterile and individually packaged transfer tube set is included in the final product packaging.