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Velcade (bortezomib) – Labelling - L01XX32

Updated on site: 10-Oct-2017

Medication nameVelcade
ATC CodeL01XX32
Substancebortezomib
ManufacturerJanssen-Cilag International NV

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON, VELCADE 1 mg

1.NAME OF THE MEDICINAL PRODUCT

VELCADE 1 mg powder for solution for injection bortezomib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 1 mg bortezomib (as a mannitol boronic ester).

3.LIST OF EXCIPIENTS

Mannitol (E421), nitrogen

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for injection 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Intravenous use only.

For single use only.

Do not give by other routes.

Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

CYTOTOXIC. Special handling instructions

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

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

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/274/002

13.BATCH NUMBER

Batch

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:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL VELCADE 1 mg

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

VELCADE 1 mg powder for solution for injection bortezomib

Intravenous use only.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mg

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON, VELCADE 3.5 mg

1. NAME OF THE MEDICINAL PRODUCT

VELCADE 3.5 mg powder for solution for injection bortezomib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).

3. LIST OF EXCIPIENTS

Mannitol (E421), nitrogen

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for injection 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Subcutaneous or Intravenous use only. For single use only.

Do not give by other routes.

Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration. Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

CYTOTOXIC. Special handling instructions

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

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

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/274/001

13. BATCH NUMBER

Batch

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:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL VELCADE 3.5 mg FLAG LABEL

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

VELCADE 3.5 mg powder for solution for injection bortezomib

Subcutaneous or Intravenous use only.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3.5 mg

6. OTHER

For single use only

Do not give by other routes.

Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration. Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.

Do not store above 30oC. Keep the vial in the outer carton in order to protect from light.

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