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Dinutuximab beta Apeiron (dinutuximab beta) – Labelling - L01XC

Updated on site: 06-Oct-2017

Medication nameDinutuximab beta Apeiron
ATC CodeL01XC
Substancedinutuximab beta
ManufacturerApeiron Biologics AG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Dinutuximab beta Apeiron 4.5 mg/mL concentrate for solution for infusion dinutuximab beta

2.STATEMENT OF ACTIVE SUBSTANCE

1 mL of concentrate contains 4.5 mg dinutuximab beta. Each 4.5 mL vial contains 20 mg dinutuximab beta.

3.LIST OF EXCIPIENTS

Histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial

20 mg/4.5 mL

5.METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use.

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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Keep the vial in the outer carton in order 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

EUSA Pharma (UK) Limited, Breakspear Park, Breakspear Way, HP2 4TZ Hemel Hempstead, United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1191/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Dinutuximab beta Apeiron

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Dinutuximab beta Apeiron 4.5 mg/mL concentrate for solution for infusion dinutuximab beta

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

20 mg/4.5 mL

6.OTHER

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