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

Updated on site: 09-Feb-2018

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOARD BOX

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

CLYNAV solution for injection for Atlantic salmon.

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 0.05 ml dose contains:

pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 – 9.4 μg.

3.PHARMACEUTICAL FORM

Solution for injection.

4.PACKAGE SIZE

250 ml

5.TARGET SPECIES

Atlantic salmon (Salmo salar).

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: Zero degree days.

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP {month/year}

Once opened use within 10 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated (2 °C – 8 °C).

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House

Priestley Road

Basingstoke

Hampshire, RG24 9NL

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/197/001

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS

EVA (250 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CLYNAV solution for injection for Atlantic salmon.

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Each 0.05 ml dose contains:

pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 – 9.4 μg.

3.CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

250 ml

4.ROUTE(S) OF ADMINISTRATION

IM

5.WITHDRAWAL PERIOD

Withdrawal period: Zero degree days.

6.BATCH NUMBER

Batch {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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