Vaxxitek HVT IBD (live vHVT013-69 recombinant virus) – Labelling - QI01AD15

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {AMPOULE 1000 and 2000 doses}

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Vaxxitek HVT+IBD

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

1000 doses

2000 doses

4.ROUTE(S) OF ADMINISTRATION

SC or in ovo route

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

STERILE DILUENT

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

STERILE DILUENT

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

3.PHARMACEUTICAL FORM

4.PACKAGE SIZE

1 bottle of 200 ml

1 bag of 200 ml

1 bag of 400 ml

1 bag of 600 ml.

1 bag of 800 ml.

1 bag of 1000 ml.

1 bag of 1200 ml.

1 bag of 1400 ml.

1 bag of 1600 ml.

1 bag of 1800 ml.

1 bag of 2400 ml

5.TARGET SPECIES

Chickens

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet supplied with the vaccine vial before use.

8.WITHDRAWAL PERIOD

Zero days

9.SPECIAL WARNING(S), IF NECESSARY

Use immediately after preparation.

Do not use if cloudy.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Store below 30°C. Do not freeze.

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

Read the package leaflet supplied with the vaccine vial before use.

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

MERIAL

29 Avenue Tony Garnier

69007 Lyon

France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/02/032/001

EU/2/02/032/002

17.MANUFACTURER’S BATCH NUMBER

Lot

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