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Xgeva (denosumab) – Labelling - M05BX04

Updated on site: 11-Oct-2017

Medication nameXgeva
ATC CodeM05BX04
Substancedenosumab
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

XGEVA 120 mg solution for injection denosumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 120 mg of denosumab in 1.7 ml of solution (70 mg/ml).

3.LIST OF EXCIPIENTS

Acetic acid, glacial, sodium hydroxide, sorbitol (E420) and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. 1 single use vial.

3 single use vials.

4 single use vials.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Do not shake excessively.

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.

Do not freeze.

Store in the original 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

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/703/001 – 1 pack

EU/1/11/703/002 – 4 pack

EU/1/11/703/003 – 3 pack

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

xgeva

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

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

XGEVA 120 mg injection denosumab

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1.7 ml

6.OTHER

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