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Kadcyla (trastuzumab emtansine) – Labelling - L01XC14

Updated on site: 08-Oct-2017

Medication nameKadcyla
ATC CodeL01XC14
Substancetrastuzumab emtansine
ManufacturerRoche Registration Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

100 mg single-use vial containing powder for concentrate for infusion solution delivers 5 mL of 20 mg/mL of trastuzumab emtansine after reconstitution.

3.LIST OF EXCIPIENTS

Excipients:

Succinic acid, sodium hydroxide, sucrose, polysorbate 20.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial of 100 mg

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution and dilution

Read the package leaflet before 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 (2ºC – 8ºC)

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/885/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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

Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine

Intravenous use

2.METHOD OF ADMINISTRATION

For intravenous use after reconstitution and dilution

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

160 mg single-use vial containing powder for concentrate for infusion solution delivers 8 mL of 20 mg/mL of trastuzumab emtansine after reconstitution

3. LIST OF EXCIPIENTS

Excipients:

Succinic acid, sodium hydroxide, sucrose, polysorbate 20.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial of 160 mg

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution and dilution

Read the package leaflet before 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 (2ºC – 8ºC)

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

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/885/002

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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

Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine

Intravenous use

2. METHOD OF ADMINISTRATION

For intravenous use after reconstitution and dilution

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

160 mg

6. OTHER

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