Clynav (pUK-SPDV-poly2#1 DNA plasmid coding...) – Summary of product characteristics - QI10AX
Updated on site: 09-Feb-2018
|Nome do medicamento:||Clynav|
|Substância:||pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins|
|Fabricante:||Elanco Europe Limited|
Conteúdo do Artigo
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
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:
For the full list of excipients, see section 6.1.
Solution for injection.
A clear, colourless,
Atlantic salmon (Salmo salar).
4.2Indications 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 is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).
4.4Special warnings for each target species
Do not use in clinically diseased groups of fish.
4.5Special precautions for use
Special precautions for use in animals
Only healthy fish should be vaccinated. A minimum body weight of 25 g is recommended at vaccination.
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
4.6Adverse reactions (frequency and seriousness)
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 reactions 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).
4.7Use during pregnancy, lactation or lay
The effect of vaccine on reproductive performance has not been investigated. Do not use in broodstock.
4.8Interaction 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.
4.9Amounts to be administered and administration route
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).
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. Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No effects other than those described in section 4.6 have been observed following the administration of an overdose.
4.11 Withdrawal period(s)
Zero degree days.
Pharmacotherapeutic group: Immunologicals for Atlantic salmon.
ATCvet code: QI10AX.
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.
6.1List of excipients
Potassium dihydrogen phosphate
Disodium hydrogen phosphate heptahydrate
Do not mix with any other veterinary medicinal products prior to or during administration.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
6.4.Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
6.5Nature and composition of immediate packaging
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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Elanco Europe Ltd.
Hampshire, RG24 9NL
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27/06/2017
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE