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Busilvex (busulfan) – Labelling - L01AB01

Updated on site: 05-Oct-2017

Medication nameBusilvex
ATC CodeL01AB01
Substancebusulfan
ManufacturerPierre Fabre Médicament

PARTICULARS TO APPEAR ON THE OUTER PACKAGING WITH BLUE BOX

{Box containing 8 vials of 10ml}

1.NAME OF THE MEDICINAL PRODUCT

Busilvex 6 mg/ml concentrate for solution for infusion busulfan

2.STATEMENT OF ACTIVE SUBSTANCE

One ml of concentrate contains 6 mg of busulfan and provides 0.5 mg/ml of busulfan after dilution

3.LIST OF EXCIPIENTS

Each vial contains Dimethylacetamide and Macrogol 400

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial

5.METHOD AND ROUTE OF ADMINISTRATION

Intravenous use (IV)

Must be diluted before use

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 IF NECESSARY

Cytotoxic: handle with caution.

8.EXPIRY DATE

EXP:

Read the leaflet for the shelf life of diluted medicine

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 C – 8 C)

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pierre Fabre Médicament 45, place Abel Gance

F-92654 Boulogne Billancourt cedex France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/03/254/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to restricted medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WITHOUT BLUE BOX

{ box containing 4 vials of 10ml}

1. NAME OF THE MEDICINAL PRODUCT

Busilvex 6 mg/ml busulfan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

60 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate

4 vials of 10ml. Component of a multipack, cannot be sold separately.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use (IV)

Must be diluted before use

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 (2 C – 8 C)

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)

EU/1/03/254/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

{10ml type I glass vial}

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

Busilvex 6 mg/ml sterile concentrate

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

60 mg/10 ml

6.OTHER

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