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Kyprolis (carfilzomib) – Labelling - L01XX45

Updated on site: 08-Oct-2017

Medication nameKyprolis
ATC CodeL01XX45
Substancecarfilzomib
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Kyprolis 10 mg powder for solution for infusion carfilzomib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 10 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

3.LIST OF EXCIPIENTS

Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion. 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only.

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 carton 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

Discard unused portions in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1060/002

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kyprolis 10 mg powder for solution for infusion carfilzomib

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 mg

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Kyprolis 30 mg powder for solution for infusion carfilzomib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 30 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

3. LIST OF EXCIPIENTS

Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion. 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only.

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 carton 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

Discard unused portions in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1060/003

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

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kyprolis 30 mg powder for solution for infusion carfilzomib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 30 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

3. LIST OF EXCIPIENTS

Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only.

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 carton 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

Discard unused portions in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1060/003

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

Kyprolis 60 mg powder for solution for infusion carfilzomib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 60 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

3. LIST OF EXCIPIENTS

Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion. 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only.

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 carton 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

Discard unused portions in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1060/001

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

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kyprolis 60 mg powder for solution for infusion carfilzomib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 60 mg of carfilzomib.

After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.

3. LIST OF EXCIPIENTS

Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use.

Single use only.

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 carton 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

Discard unused portions in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1060/001

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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