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Empliciti (elotuzumab) – Labelling - L01XC

Updated on site: 06-Oct-2017

Medication nameEmpliciti
ATC CodeL01XC
Substanceelotuzumab
ManufacturerBristol-Myers Squibb

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Empliciti 300 mg powder for concentrate for solution for infusion elotuzumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 300 mg elotuzumab.

After reconstitution, each mL of concentrate contains 25 mg elotuzumab.

3.LIST OF EXCIPIENTS

Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1088/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Empliciti 300 mg powder for concentrate elotuzumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 300 mg elotuzumab.

After reconstitution, each mL of concentrate contains 25 mg elotuzumab.

3. LIST OF EXCIPIENTS

Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

300 mg powder for concentrate

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use.

IV use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1088/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg elotuzumab.

After reconstitution, each mL of concentrate contains 25 mg elotuzumab.

3. LIST OF EXCIPIENTS

Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1088/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Empliciti 400 mg powder for concentrate elotuzumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg elotuzumab.

After reconstitution, each mL of concentrate contains 25 mg elotuzumab.

3. LIST OF EXCIPIENTS

Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

400 mg powder for concentrate

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use.

IV use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1088/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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