Zactran (gamithromycin) – Labelling - QJ01FA95

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

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

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains 150 mg of gamithromycin,

3.PHARMACEUTICAL FORM

Solution for injection

4.PACKAGE SIZE

50 ml

100 ml

250 ml

5.TARGET SPECIES

Cattle, sheep, pigs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle and sheep: Subcutaneous use

Pigs: Intramuscular use

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal periods:

Meat and offal: Cattle: 64 days. Sheep: 29 days. Pigs: 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 (cows, heifers) or 1 month (ewes) of expected parturition.

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days

Once opened, use by __/__/__

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

MERIAL

29 avenue Tony Garnier

69007 Lyon France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/08/082/001

EU/2/08/082/002

EU/2/08/082/004

EU/2/08/082/005

EU/2/08/082/007

17.MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (500 ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains 150 mg of gamithromycin,

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

500 ml

5. TARGET SPECIES

Cattle, pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle: Subcutaneous use

Pigs: Intramuscular use

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal periods:

Meat and offal: Cattle: 64 days. Pigs: 16 days.

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

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

9. SPECIAL WARNING(S), IF NECESSARY

10. EXPIRY DATE

EXP

Shelf life after first opening the container: 28 days

Once opened, use by __/__/__

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

MERIAL

29 avenue Tony Garnier

69007 Lyon France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/082/003

EU/2/08/082/006

17. MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS

VIAL 50 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin

2.QUANTITY OF THE ACTIVE SUBSTANCE

1 ml contains 150 mg of gamithromycin

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

50 ml

4.ROUTE OF ADMINISTRATION

SC (cattle, sheep), IM (pigs)

5.WITHDRAWAL PERIOD(S)

Withdrawal periods: Meat and offal: Cattle: 64 days. Sheep: 29 days. Pigs: 16 days Not authorised for use in animals producing milk for human consumption.

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP

Once opened, use by __/__/__

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

VIAL 100 ml, 250 ml,

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains 150 mg of gamithromycin,

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

100 ml

250 ml

5. TARGET SPECIES

Cattle, sheep, pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

SC (cattle, sheep) IM (pigs)

Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal periods:

Meat and offal: Cattle: 64 days. Sheep: 29 days. Pigs: 16 days

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

9. SPECIAL WARNING(S), IF NECESSARY

10. EXPIRY DATE

EXP

Once opened, use by __/__/__

11. SPECIAL STORAGE CONDITIONS

12. 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.

13.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MERIAL

29 avenue Tony Garnier

69007 Lyon France

14.MARKETING AUTHORISATION NUMBER(S)

EU/2/08/082/001

EU/2/08/082/002

EU/2/08/082/004

EU/2/08/082/005

15.MANUFACTURER’S BATCH NUMBER

Lot

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

VIAL 500 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains 150 mg of gamithromycin,

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

500 ml

5. TARGET SPECIES

Cattle, pigs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

SC (cattle) IM (pigs)

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period:

Meat and offal: Cattle: 64 days. Pigs: 16 days

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

9. SPECIAL WARNING(S), IF NECESSARY

10. EXPIRY DATE

EXP

Once opened, use by __/__/__

11. SPECIAL STORAGE CONDITIONS

12. 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.

13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MERIAL

29 avenue Tony Garnier

69007 Lyon France

14. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/082/003

EU/2/08/082/006

15. MANUFACTURER’S BATCH NUMBER

Lot

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