Bluevac BTV8 (bluetongue virus inactivated, serotype...) – Labelling - QI04AA02

Updated on site: 21-Sep-2017

Medication name: Bluevac BTV8
ATC: QI04AA02
Substance: bluetongue virus inactivated, serotype 8
Manufacturer: CZ Veterinaria S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (52 ml, 100 ml and 252 ml)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

BLUEVAC BTV8 suspension for injection for cattle and sheep

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each ml of vaccine contains:

BTV8 antigen 106.5 CCID50

3.PHARMACEUTICAL FORM

Suspension for injection

4.PACKAGE SIZE

52 ml

100 ml

252 ml

5.TARGET SPECIES

Sheep and cattle

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Shake well before use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once opened, use within 10 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Protect from light.

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

CZ Veterinaria, S.A.

36400 Porriño

SPAIN

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/11/122/001 bottle of 52 ml

EU/2/11/122/002 bottle of 100 ml

EU/2/11/122/003 bottle of 252 ml

17.MANUFACTURER’S BATCH NUMBER

Batch: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Bottle of 100 ml and 252 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BLUEVAC BTV8 suspension for injection for cattle and sheep

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

BTV 8 antigen ……… 106.5 CCID50/ml.

3. PHARMACEUTICAL FORM

Suspension for injection

4. PACKAGE SIZE

100 ml

252 ml

5. TARGET SPECIES

Sheep and cattle

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

SC

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period: Zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Once opened, use within 10 hours.

11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Protect from light.

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

CZ Veterinaria, S.A.

36400 Porriño

SPAIN

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/122/002

EU/2/11/122/003

17. MANUFACTURER’S BATCH NUMBER

Batch: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Bottle of 52 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BLUEVAC BTV8 suspension for injection for cattle and sheep

2.QUANTITY OF THE ACTIVE SUBSTANCE

BTV 8 antigen ……… 106.5 CCID50/ml.

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

52 ml

4.ROUTE OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

6.BATCH NUMBER

Batch: {number}

7.EXPIRY DATE

EXP {month/year}

Once opened, use within 10 hours.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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