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Docetaxel Kabi (docetaxel) – Labelling - L01CD02

Updated on site: 06-Oct-2017

Medication nameDocetaxel Kabi
ATC CodeL01CD02
Substancedocetaxel
ManufacturerFresenius Kabi Oncology Plc

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion

docetaxel

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 20 mg docetaxel anhydrous.

One vial of 1 ml of concentrate contains 20 mg of docetaxel.

3.LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial with 20 mg/1 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Ready to add to infusion solution.

Read the package leaflet before use.

Intravenous use

Single-use vial.

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

Cytotoxic

8.EXPIRY DATE

Exp:

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon

Hampshire, GU35 0NF

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/770/005

13.BATCH NUMBER

Lot:

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

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion

docetaxel

Intravenous use.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

Exp:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

20 mg/1 ml

6.OTHER

Cytotoxic

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion

docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 20 mg docetaxel anhydrous.

One vial of 4 ml of concentrate contains 80 mg of docetaxel.

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial with 80 mg/4 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ready to add to infusion solution.

Read the package leaflet before use.

Intravenous use

Single-use vial.

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

Cytotoxic

8. EXPIRY DATE

Exp:

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon

Hampshire, GU35 0NF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/770/001

13. BATCH NUMBER

Lot:

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

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion

docetaxel

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

Exp:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

80 mg/4 ml

6. OTHER

Cytotoxic

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion

docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 20 mg docetaxel anhydrous.

One vial of 6 ml of concentrate contains 120 mg of docetaxel.

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial with 120 mg/6 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ready to add to infusion solution.

Read the package leaflet before use.

Intravenous use

Single-use vial.

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

Cytotoxic

8. EXPIRY DATE

Exp:

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon

Hampshire, GU35 0NF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/770/002

13. BATCH NUMBER

Lot:

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

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion

docetaxel

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

Exp:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

120 mg/6 ml

6. OTHER

Cytotoxic

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion

docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 20 mg docetaxel anhydrous.

One vial of 8 ml of concentrate contains 160 mg of docetaxel.

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial with 160 mg/8 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ready to add to infusion solution.

Read the package leaflet before use.

Intravenous use

Single-use vial.

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

Cytotoxic

8. EXPIRY DATE

Exp:

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon

Hampshire, GU35 0NF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/770/003

13. BATCH NUMBER

Lot:

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

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion

docetaxel

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

Exp:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

160 mg/8 ml

6. OTHER

Cytotoxic

PARTICULARS TO APPEAR ON OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion

docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 20 mg docetaxel anhydrous.

One vial of 9 ml of concentrate contains 180 mg of docetaxel.

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

1 vial with 180 mg/9 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ready to add to infusion solution.

Read the package leaflet before use.

Intravenous use

Single-use vial.

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

Cytotoxic

8. EXPIRY DATE

Exp:

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon

Hampshire, GU35 0NF

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/770/004

13. BATCH NUMBER

Lot:

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

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion

docetaxel

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

Exp:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

180 mg/9 ml

6. OTHER

Cytotoxic

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