Draxxin (tulathromycin) – Labelling - QJ01FA94

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (20 ml / 50 ml / 100 ml / 250 ml)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin

2.STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

100 mg/ml

3.PHARMACEUTICAL FORM

Solution for injection

4.PACKAGE SIZE

20 ml

50 ml

100 ml

250 ml

5.TARGET SPECIES

Cattle, pigs and sheep

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle: For subcutaneous use.

Pigs and sheep: For intramuscular use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal periods:

Meat and offal:

Cattle: 22 days.

Pigs: 13 days.

Sheep: 16 days.

Not authorised for use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

11.SPECIAL STORAGE CONDITIONS

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/001 (20 ml)

EU/2/03/041/002 (50 ml)

EU/2/03/041/003 (100 ml)

EU/2/03/041/004 (250 ml)

17.MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (500 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 100 mg/ml solution for injection for cattle tulathromycin

2. STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

100 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

500 ml

5. TARGET SPECIES

Cattle

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 22 days.

Not authorised for use in lactating cattle producing milk for human consumption.

Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

11. SPECIAL STORAGE CONDITIONS

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/005

17. MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (50 ml / 100 ml / 250 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 25 mg/ml solution for injection for pigs tulathromycin

2. STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

25 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

50 ml

100 ml

250 ml

5. TARGET SPECIES

Pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For intramuscular use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 13 days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

11. SPECIAL STORAGE CONDITIONS

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/006 (50 ml)

EU/2/03/041/007 (100 ml)

EU/2/03/041/008 (250 ml)

17. MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Vial (100 ml / 250 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin

2. STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

100 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

100 ml

250 ml

5. TARGET SPECIES

Cattle, pigs and sheep

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle: SC.

Pigs and sheep: IM.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal periods:

Meat and offal:

Cattle: 22 days.

Pigs: 13 days.

Sheep: 16 days.

Not authorised for use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

Once broached use by

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL 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”

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/003 (100 ml)

EU/2/03/041/004 (250 ml)

17. MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Vial (500 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 100 mg/ml solution for injection for cattle tulathromycin

2. STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

100 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

500 ml

5. TARGET SPECIES

Cattle

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 22 days.

Not authorised for use in lactating cattle producing milk for human consumption.

Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

Once broached use by

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL 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”

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/005

17. MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Vial (100 ml / 250 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 25 mg/ml solution for injection for pigs tulathromycin

2. STATEMENT OF ACTIVE SUBSTANCES

 

 

Tulathromycin

25 mg/ml

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

100 ml

250 ml

5. TARGET SPECIES

Pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For intramuscular use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 13 days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days.

Once broached use by

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL 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”

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/03/041/007 (100 ml)

EU/2/03/041/008 (250 ml)

17. MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial (20 ml / 50 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

 

 

Tulathromycin

100 mg/ml

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

20 ml

50 ml

4.ROUTE(S) OF ADMINISTRATION

Cattle: SC.

Pigs and sheep: IM.

5.WITHDRAWAL PERIOD(S)

Withdrawal periods:

Meat and offal:

Cattle: 22 days.

Pigs: 13 days.

Sheep: 16 days.

Not authorised for use in lactating animals producing milk for human consumption.

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP

Once broached use by

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Draxxin 25 mg/ml solution for injection for pigs tulathromycin

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

 

 

Tulathromycin

25 mg/ml

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

50 ml

4. ROUTE(S) OF ADMINISTRATION

IM

5. WITHDRAWAL PERIOD(S)

Withdrawal period:

Meat and offal: 13 days.

6. BATCH NUMBER

Lot

7. EXPIRY DATE

EXP

Once broached use by

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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