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Opdivo (nivolumab) – Labelling - L01XC

Updated on site: 09-Oct-2017

Medication nameOpdivo
ATC CodeL01XC
Substancenivolumab
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of concentrate contains 10 mg of nivolumab.

Each vial of 4 mL contains 40 mg of nivolumab.

Each vial of 10 mL contains 100 mg of nivolumab.

3.LIST OF EXCIPIENTS

Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion.

40 mg/4 mL

100 mg/10 mL

1 vial

5.METHOD AND ROUTE(S) 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

For single use only.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package 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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1014/001 40 mg vial

EU/1/15/1014/002 100 mg vial

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

OPDIVO 10 mg/mL sterile concentrate nivolumab

IV use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

40 mg/4 mL

100 mg/10 mL

6.OTHER

For single use only.

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