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Kanuma (sebelipase alfa) – Labelling - A16

Updated on site: 08-Oct-2017

Medication nameKanuma
ATC CodeA16
Substancesebelipase alfa
ManufacturerAlexion Europe SAS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)

3.LIST OF EXCIPIENTS

Excipients:

Trisodium citrate dihydrate (see leaflet for further information)

Citric acid monohydrate

Human serum albumin

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial of 10 ml

20 mg/10 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous use after dilution.

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.

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

Alexion Europe SAS

1-15, avenue Edouard Belin

92500 Rueil-Malmaison France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1033/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

10 ml VIAL

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

KANUMA 2 mg/ml sterile concentrate sebelipase alfa

IV use after dilution

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

20 mg/10 ml

6.OTHER

Store in a refrigerator

Do not freeze.

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