PARTICULARS TO APPEAR ON THE OUTER PACKAGING

1. NAME OF THE MEDICINAL PRODUCT

Indium (In111) Chloride DRN 4901 (= Code on vial)

2.    STATEMENT OF ACTIVE SUBSTANCE(S) Indium (In111) chloride y MBq in x mL at ART

y MBq [YYYY-MM-DD hh:mm] h CET

3.    LIST OF EXCIPIENTS

Also contains: hydrochloric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Radiopharmaceutical precursor 1 multidose vial of 370 MBq/ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For radiolabelling. 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

First use: [YYYY-MM-DD hh:mm] h CET

8. EXPIRY DATE

EXP: [YYYY-MM-DD hh:mm] h CET

9. SPECIAL STORAGE CONDITIONS

Store below 25 °C.

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

After decay of radioactivity there are no speciál precautions for waste disposal.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mallinckrodt Medical BV, Westerduinweg 3, 1755 LE Petten, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

88/380/93-C

13. BATCH NUMBER

Lot: [12345]

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

[Neuplatňuje se - odůvodnění přijato]

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS In case of radiopharmaceuticals the vial should be labelled in accordance to the article 66(3) of Directive 2001/83.

Vial label: In-111

1. THE NAME OR CODE OF THE MEDICINAL PRODUCT, INCLUDING THE NAME OR CHEMICAL SYMBOL OF THE RADIONUCLIDE

DRN 4901 In-111

2. THE AMOUNT OF RADIOACTIVITY

y MBq/x mL

[YYYY-MM-DD hh:mm] h CET

3. EXPIRY DATE

EXP: [YYYY-MM-DD hh:mm] h CET

4. BATCH NUMBER

Lot: [00000/000]

5. THE NAME OF THE MANUFACTURER

Mallinckrodt Medical BV

6. THE INTERNATIONAL SYMBOL FOR RADIOACTIVITY