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Abraxane (paclitaxel) – Labelling - L01CD01

Updated on site: 11-Jul-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1.NAME OF THE MEDICINAL PRODUCT

Abraxane 5 mg/ml powder for suspension for infusion

paclitaxel

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.

After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

3.LIST OF EXCIPIENTS

Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).

Contains sodium, see package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for suspension for infusion.

1 vial

100 mg/20 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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

Abraxane should not be substituted for or with other paclitaxel formulations.

8.EXPIRY DATE

EXP:

9.SPECIAL STORAGE CONDITIONS

Unopened vials: Keep the vial in the outer carton in order to protect from light.

After first reconstitution: 8 hours in a refrigerator in the vial when kept in the outer carton in order to protect from light.

In an infusion bag: up to 8 hours not above 25°C.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Celgene Europe Limited

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/428/001

13.BATCH NUMBER

Batch:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Vial

1. NAME OF THE MEDICINAL PRODUCT

Abraxane 5 mg/ml powder for suspension for infusion

paclitaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of suspension contains 5 mg of paclitaxel.

3. LIST OF EXCIPIENTS

Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).

Contains sodium, see package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for suspension for infusion.

1 vial

100 mg/20 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

Unopened vials: Keep the vial in the outer 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

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Celgene Europe Ltd

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/428/001

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

Abraxane 5 mg/ml powder for suspension for infusion

paclitaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.

After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

3. LIST OF EXCIPIENTS

Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).

Contains sodium, see package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for suspension for infusion.

1 vial

250 mg/50 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

Abraxane should not be substituted for or with other paclitaxel formulations.

8. EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Unopened vials: Keep the vial in the outer carton in order to protect from light.

After first reconstitution: 8 hours in a refrigerator in the vial when kept in the outer carton in order to protect from light.

In an infusion bag: up to 8 hours not above 25°C.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Celgene Europe Limited

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/428/002

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Vial

1. NAME OF THE MEDICINAL PRODUCT

Abraxane 5 mg/ml powder for suspension for infusion

paclitaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of suspension contains 5 mg of paclitaxel.

3. LIST OF EXCIPIENTS

Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).

Contains sodium, see package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for suspension for infusion.

1 vial

250 mg/50 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

Unopened vials: Keep the vial in the outer 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

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Celgene Europe Ltd

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/428/002

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

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