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Benlysta (belimumab) – Labelling - L04AA26

Updated on site: 05-Oct-2017

Medication nameBenlysta
ATC CodeL04AA26
Substancebelimumab
ManufacturerGlaxo Group Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Benlysta 120 mg powder for concentrate for solution for infusion

Belimumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 120 mg belimumab (80 mg/ml after reconstitution)

3.LIST OF EXCIPIENTS

Citric acid monohydrate (E330), sodium citrate (E331), sucrose, polysorbate 80

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial

5.METHOD AND ROUTE OF ADMINISTRATION

For intravenous infusion after reconstitution and dilution.

Read the package leaflet before use.

Intravenous use.

For single use only.

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,

Do not freeze.

Store in the original carton 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

Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/700/001

13.BATCH NUMBER, DONATION AND PRODUCT CODES

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Benlysta 400 mg powder for concentrate for solution for infusion

Belimumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 400 mg belimumab (80 mg/ml after reconstitution)

3. LIST OF EXCIPIENTS

Citric acid monohydrate (E330), sodium citrate (E331), sucrose, polysorbate 80

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial

5. METHOD AND ROUTE OF ADMINISTRATION

For intravenous infusion after reconstitution and dilution.

Read the package leaflet before use.

Intravenous use.

For single use only.

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.

Do not freeze.

Store in the original carton 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

Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/700/002

13. BATCH NUMBER, DONATION AND PRODUCT CODES

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

120 mg VIAL LABEL

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

Benlysta 120 mg powder for concentrate for solution for infusion

Belimumab

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

120 mg

6.OTHER

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 400 mg VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

Benlysta 400 mg powder for concentrate for solution for infusion

Belimumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

5. METHOD AND ROUTE OF ADMINISTRATION

For intravenous infusion 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

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

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