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Yondelis (trabectedin) – Labelling - L01CX01

Updated on site: 11-Oct-2017

Medication nameYondelis
ATC CodeL01CX01
Substancetrabectedin
ManufacturerPharma Mar S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton – 0.25 mg vial

1.NAME OF THE MEDICINAL PRODUCT

Yondelis 0.25 mg powder for concentrate for solution for infusion

Trabectedin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 0.25 mg of trabectedin.

1 ml of reconstituted solution contains 0.05 mg of trabectedin.

3.LIST OF EXCIPIENTS

Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution and further 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 Cytotoxic: Handle with caution.

8.EXPIRY DATE

EXP:

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.

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

Discard any unused product or waste material in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pharma Mar, S.A. Avda. de los Reyes 1 Pol. Ind. La Mina

28770 Colmenar Viejo (Madrid) Spain

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/417/001

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 – 0.25 mg vial

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

Yondelis 0.25 mg powder for concentrate for solution for infusion

Trabectedin

IV use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.25 mg trabectedin

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton – 1 mg vial

1. NAME OF THE MEDICINAL PRODUCT

Yondelis 1 mg powder for concentrate for solution for infusion

Trabectedin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 1 mg of trabectedin.

1 ml of reconstituted solution contains 0.05 mg of trabectedin.

3. LIST OF EXCIPIENTS

Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution and further 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 Cytotoxic: Handle with caution.

8. EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.

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

Discard any unused product or waste material in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pharma Mar, S.A. Avda. de los Reyes 1 Pol. Ind. La Mina

28770 Colmenar Viejo (Madrid) Spain

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/417/002

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 mg vial

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

Yondelis 1 mg powder for concentrate for solution for infusion

Trabectedin

IV use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mg trabectedin

6. OTHER

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