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Erbitux (cetuximab) – Labelling - L01XC06

Updated on site: 06-Oct-2017

Medication nameErbitux
ATC CodeL01XC06
Substancecetuximab
ManufacturerMerck KGaA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Erbitux 5 mg/mL solution for infusion

Cetuximab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).

Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).

3.LIST OF EXCIPIENTS

Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion

1 vial of 100 mg/20 mL

1 vial of 500 mg/100 mL

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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.

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

Merck KGaA

64271 Darmstadt

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/281/003

EU/1/04/281/005

13.BATCH NUMBER

BN

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:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Erbitux 5 mg/mL solution for infusion

Cetuximab

Intravenous use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg/20 mL

500 mg/100 mL

6.OTHER

Store in a refrigerator.

Merck KGaA

64271 Darmstadt

Germany

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