PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

1. NAME OF THE MEDICINAL PRODUCT

UltraTechneKow FM DRN 4329

2.    STATEMENT OF ACTIVE SUBSTANCE(S)

x,xx GBq DD MMM YYYY HHmm CET

3. LIST OF EXCIPIENTS

Elution with sodium chloride 0,9% solution in a 5, 11 or 25 ml vial.

4. PHARMACEUTICAL FORM AND CONTENTS

Mo99/Tc99m radionuclide generator.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use and radiolabelling.

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: DD MMM YYYY

9. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C. Do not refrigerate.

The eluate is stable for 8 hours and should be stored at 2-8°C.

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

Radioactive waste disposal should be disposed of in accordance with national regulations. Afiter decay of radioactivity there are no special precautions for waste disposal.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mallinckrodt Medical B.V. Westerduinweg 3 1755 LE, Petten the Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

88/419/92-C

13. BATCH NUMBER

Lot: xxxxx

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medicinal prescription.

15. INSTRUCTIONS ON USE

See insert for further information.

16. INFORMATION IN BRAILLE

Nevyžaduje se - odůvodnění přijato.