PARTICULARS TO APPEAR ON THE OUTER PACKAGING GENERÁTOR

1. NAME OF THE MEDICINAL PRODUCT

ELUMATIC III,TECHNETIUM (99MTC) GENERÁTOR 2-20 GBq radionuclide generátor

Sodium pertechnetate (^99mTc)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Sodium pertechnetate (^99mTc) generátor activity at calibration date:

^99mTc activity:_GBq at manufacturing date: DD/MM/YYYY (12h00 CET)

^99mTc activity:_GBq at calibration date:    DD/MM/YYYY (12h00 CET)

3. LIST OF EXCIPIENTS

Sodium chloride, sodium nitrate, water for injection

4. PHARMACEUTICAL FORM AND CONTENTS

Radionuclide generator.

Contains 10 glass vials under vacuum for a 5 mL elution.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous or ocular use

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Radioactive medicine (Radioactivity symbol)

8. EXPIRY DATE

EXP: DD/MM/YYYY (12h00 CET)

Sodium pertechnetate (^99mTc) eluate: after elution, use within 10 hours.

9. SPECIÁL STORAGE CONDITIONS

Do not store the generator above 25°C.

10. SPECIÁL 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 B.P. 32

91192 Gif-sur-Yvette Cedex France

12. MARKETING AUTHORISATION NUMBER(S)

88/195/88-C

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

<Justification for not including Braille accepted>