PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Metal box and lead Pot_

1.    NAME OF THE MEDICINAL PRODUCT_

RE-186-MM-1

RHENIUM (¹⁸⁶Re) SULPHIDE CIS bio International 148-370 MBq/mL suspension for local injection Colloidal rhenium (¹⁸⁶Re) sulphide

2.    STATEMENT OF ACTIVE SUBSTANCE(S)_

Colloidal rhenium (¹⁸⁶Re) sulphide    148 to 370 MBq/ml at calibration date

3. LIST OF EXCIPIENTS

Ascorbic acid Gelatin

Sodium hydroxide Hydrochloric acid Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in multidose vial. Vol:.....ml

.....MBq/vial {JJ/MM/AAAA} 12 h CET

.....MBq/ml {JJ/MM/AAAA} 12 h CET

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intra-articular injection under arthrographic guidance. 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 reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Radioactivity symbol Radioactive medicine

EXP: JJ/MM/AAAA

9.    SPECIÁL STORAGE CONDITIONS

Do not store above 25 °C. Store in the originál packaging

After first withdrawing, store in a refrigerator (2 °C - 8 °C) and use within 8 hours.

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

Any unused 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, Francie

12. MARKETING AUTHORISATION NUMBER(S)

MA Nr: 88/099/01-C

13. BATCH NUMBER

Batch N° :

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 IMMEDIATE PACKAGING UNITS Vial

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

RE-186-MM-1

RHENIUM (¹⁸⁶Re) SULPHIDE CIS bio International 148-370 MBq/mL suspension for local injection. Colloidal rhenium (¹⁸⁶Re) sulphide

Intra-articular use

2. METHOD OF ADMINISTRATION

For intra-articular injection under arthrographic guidance.

3. EXPIRY DATE

EXP: MM/AAAA

4. BATCH NUMBER

Batch N°

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

MBq/vial {JJ/MM/AAAA} (12h CET)

6. OTHER

Radioactivity symbol