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Dacogen (decitabine) – Labelling - L01BC08

Updated on site: 06-Oct-2017

Medication nameDacogen
ATC CodeL01BC08
Substancedecitabine
ManufacturerJanssen-Cilag International N V  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Dacogen 50 mg powder for concentrate for solution for infusion decitabine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 50 mg decitabine.

After reconstitution, 1 ml concentrate contains 5 mg decitabine.

3.LIST OF EXCIPIENTS

Excipients: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid (for pH adjustment).

See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion. 1 vial

5.METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Intravenous 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 Cytotoxic

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Unopened vial: Do not store above 25 C.

Read the leaflet for the shelf-life of the reconstituted and diluted product.

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12.MARKETING AUTHORISATION NUMBER

EU/1/12/792/001

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

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

Dacogen 50 mg powder for infusion decitabine

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg

6. OTHER

Cytotoxic

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