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Quadramet (samarium [153Sm] lexidronam pentasodium) – Labelling - V10BX02

Updated on site: 09-Oct-2017

Medication nameQuadramet
ATC CodeV10BX02
Substancesamarium [153Sm] lexidronam pentasodium
ManufacturerCIS bio international

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

METALLIC BOX / LEADPOT

1.NAME OF THE MEDICINAL PRODUCT

Quadramet 1.3 GBq/mL solution for injection

Samarium (153Sm) lexidronam pentasodium

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Samarium (153Sm) lexidronam pentasodium

:

1.3 GBq/ml at reference date.

(Corresponding to 20 to 80 µg/ml of samarium)

 

 

3.LIST OF EXCIPIENTS

Total EDTMP (as EDTMP.H2O)

Calcium-EDTMP sodium salt (as Ca)

Total sodium (as Na)

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a single-dose vial.

ml

GBq/vial,

 

(12 h CET)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

For 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

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

Store in a freezer at -10°C to -20°C in the original package

Use within 6 hours of thawing

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

CIS bio international, Boîte Postale 32,

91192 GIF-SUR-YVETTE Cedex, FRANCE

12.MARKETING AUTHORISATION NUMBER

EU/1/97/057/001

13.BATCH NUMBER

Batch :

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

<Justification for not including Braille accepted>

MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS

GLASS VIAL

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

Quadramet 1.3 GBq/mL solution for injection

Samarium (153Sm) lexidronam pentasodium

For intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

Batch:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

ml

GBq/vial,

 

(12 h CET)

6.OTHER

Manufacturer: CIS bio international.

Comments

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