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Cyramza (ramucirumab) – Labelling - L01XC

Updated on site: 06-Oct-2017

Medication nameCyramza
ATC CodeL01XC
Substanceramucirumab
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON - 10 ml vial

1.NAME OF THE MEDICINAL PRODUCT

Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of concentrate contains 10 mg ramucirumab.

3.LIST OF EXCIPIENTS

Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

100 mg/10 ml

1vial

2vials

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after dilution.

For single use only.

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

Do not shake.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V.

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/957/001 - 1 vial of 10 ml.

EU/1/14/957/002 - 2 vials of 10 ml.

13.BATCH NUMBER

Lot

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:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – 50 ml vial

1. NAME OF THE MEDICINAL PRODUCT

Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of concentrate contains 10 mg ramucirumab.

3. LIST OF EXCIPIENTS

Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

500 mg/50 ml

1vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after dilution.

For single use only.

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

Do not shake.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V.

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/957/003

13. BATCH NUMBER

Lot

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 LABEL – 10 ml vial

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

Cyramza 10 mg/ml sterile concentrate ramucirumab

For IV use after dilution.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg/10 ml

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL – 50 ml vial

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

Cyramza 10 mg/ml sterile concentrate ramucirumab

For IV use after dilution.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 mg/50 ml

6. OTHER

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