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DepoCyte (cytarabine) – Labelling - L01BC01

Updated on site: 06-Oct-2017

Medication nameDepoCyte
ATC CodeL01BC01
Substancecytarabine
ManufacturerPacira Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1.NAME OF THE MEDICINAL PRODUCT

DepoCyte 50 mg suspension for injection

Cytarabine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 50 mg cytarabine (10 mg/ml).

3.LIST OF EXCIPIENTS

Also contains: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. One 5 ml vial.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intrathecal 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(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2ºC - 8ºC).

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

Pacira Limited

Wessex House

Marlow Road

Bourne End

Buckinghamshire

SL8 5SP

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/187/001

13.BATCH NUMBER

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.

17.UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

DepoCyte 50 mg suspension for injection

Cytarabine

Intrathecal use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml.

6.OTHER

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