BTVPUR (bluetongue-virus serotype-1 antigen...) – Labelling - QI04AA02

Updated on site: 08-Feb-2018

Medication name: BTVPUR
ATC: QI04AA02
Substance: bluetongue-virus serotype-1 antigen /bluetongue-virus serotype-8 antigen
Manufacturer: Merial

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box of 1 bottle of 10 ml,

Box of 1 bottle of 50 ml,

Box of 10 bottles of 50 ml,

Box of 1 bottle of 100 ml,

Box of 10 bottles of 100 ml

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

BTVPUR suspension for injection for sheep and cattle

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each dose of 1 ml contains:

Inactivated BTV ....................................................................≥ strain specific pass level (log10 pixels) The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the package and in the package leaflet. l

3.PHARMACEUTICAL FORM

Suspension for injection

4.PACKAGE SIZE

10 doses (10 ml)

50 doses (50 ml)

10 x 50 doses (10 x 50 ml)

100 doses (100 ml)

10 x 100 doses (10 x100 ml)

5.TARGET SPECIES

Sheep and cattle

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: zero days

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP {month/year}

Once broached, use immediately.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Protect from light.

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

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/2/10/113/001-030

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 and 50 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BTVPUR injection for sheep and cattle

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Inactivated BTV ........................................................................≥ strain specific pass level (log10 pixels) The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the package and in the package leaflet.

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

10 doses (10 ml)

50 doses (50 ml)

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

Withdrawal period: zero days

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

Once broached, use immediately.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Bottle of 100 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BTVPUR suspension for injection for sheep and cattle

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each dose of 1ml contains Bluetongue Virus

 

Inactivated BTV ..........................................................................

≥ strain specific pass level (log10 pixels)

The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the package and in the package leaflet.

3. PHARMACEUTICAL FORM

Suspension for injection

4. PACKAGE SIZE

100 doses (100 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

10. EXPIRY DATE

EXP {month/year}

Once broached, use immediately

11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze

Protect from light.

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

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/2/10/113/001-002

EU/2/10/113/006-007

EU/2/10/113/011-012

EU/2/10/113/016-017

EU/2/10/113/021-022

EU/2/10/113/026-027

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

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