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Kyntheum (brodalumab) – Labelling - L04AC12

Updated on site: 08-Oct-2017

Medication nameKyntheum
ATC CodeL04AC12
Substancebrodalumab
ManufacturerLEO Pharma A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution (140 mg/1 ml).

3.LIST OF EXCIPIENTS

Excipients: proline, glutamate, polysorbate 20 and water for injection.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

2 pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use

For single use only

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

Do not shake.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the outer 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

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1155/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Kyntheum 210 mg

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

PRE-FILLED SYRINGE LABEL

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

Kyntheum 210 mg injection brodalumab

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

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