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Xyrem (sodium oxybate) – Labelling - N07XX04

Updated on site: 11-Oct-2017

Medication nameXyrem
ATC CodeN07XX04
Substancesodium oxybate
ManufacturerUCB Pharma Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE OUTER PACKAGING

Carton and bottle

1.NAME OF THE MEDICINAL PRODUCT

Xyrem 500 mg/mL oral solution

Sodium oxybate

2.STATEMENT OF ACTIVE SUBSTANCE

Each mL of solution contains 500 mg sodium oxybate

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

One bottle of 180 mL oral solution

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

The medicinal product should be used within 40 days after the first opening. After dilution in the dosing cups the preparation should be used within 24 hours.

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

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE.

UK.

12.MARKETING AUTHORISATION NUMBER

EU/1/05/312/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Xyrem 500 mg/mL (applies to carton only)

17.UNIQUE IDENTIFIER – 2D BARCODE

The following statement should be included in this section in grey-shading: <2D barcode carrying the unique identifier included.>]

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

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