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Avastin (bevacizumab) – Labelling - L01XC07

Updated on site: 05-Oct-2017

Medication nameAvastin
ATC CodeL01XC07
Substancebevacizumab
ManufacturerRoche Registration Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Avastin 25 mg/ml concentrate for solution for infusion

Bevacizumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg bevacizumab.

3.LIST OF EXCIPIENTS

Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial of 4 ml

100 mg/4 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after 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

This medicinal product does not contain any preservative

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton

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/1/04/300/001

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

<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

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

Avastin 25 mg/ml concentrate for solution for infusion

Bevacizumab

IV

2.METHOD OF ADMINISTRATION

For intravenous use after dilution

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg/4 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Avastin 25 mg/ml concentrate for solution for infusion

Bevacizumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg bevacizumab.

3. LIST OF EXCIPIENTS

Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial of 16 ml

400 mg/16 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after 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

This medicinal product does not contain any preservative

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton

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/1/04/300/002

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

<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

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

Avastin 25 mg/ml concentrate for solution for infusion

Bevacizumab

IV

2. METHOD OF ADMINISTRATION

For intravenous use after dilution

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

400 mg/16 ml

6. OTHER

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