Clynav (pUK-SPDV-poly2#1 DNA plasmid coding...) – Package leaflet - QI10AX

Updated on site: 21-Sep-2017

Наименование на лекарството: Clynav
ATC: QI10AX
Вещество: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins
Производител: Elanco Europe Limited

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.

Lilly House

Priestley Road

Basingstoke

Hampshire, RG24 9NL

UNITED KINGDOM

Manufacturer responsible for batch release:

Elanco Animal Health

Eli Lilly and Company Limited, Speke Operations

Fleming road

Liverpool

L24 9LN

UNITED KINGDOM

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: 5.1 – 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 is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).

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 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.

7.TARGET SPECIES

Atlantic salmon (Salmo salar).

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

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 mid-line. Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely. Consideration should be made for the weight of the fish before the final selection is made. Injection equipment should be calibrated and inspected regularly to ensure appropriate dosing of the fish.

10.WITHDRAWAL PERIOD

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.

12.SPECIAL WARNING(S)

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.

Overdose

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 self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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/).

15.OTHER INFORMATION

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.

Pack size:

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.

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