PARTICULARS TO APPEAR ON THE OUTER PACKAGING Metal box and lead pot

1.    NAME OF THE MEDICINAL PRODUCT_

ERMM-1 111 MBq/ml suspension for local injection Erbium (¹⁶⁹Er) citrate

2.    STATEMENT OF ACTIVE SUBSTANCE(S)_

Erbium (¹⁶⁹Er) citrate 111 MBq/ml at calibration date

3. LIST OF EXCIPIENTS

Sodium chloride Nitric acid Sodium hydroxide Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

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

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

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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intra-articular injection 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

Radioactivity symbol Radioactive medicine

8. EXPIRY DATE

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

F-91192 GIF-SUR-YVETTE CEDEX

12. MARKETING AUTHORISATION NUMBER(S)

88/349/03-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

Nevyžaduje se-odůvodnění přijato.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial

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

ERMM-1 111 MBq/ml suspension for local injection Erbium (¹⁶⁹Er) citrate

Intra-articular use

Vol :.....ml

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

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

6. OTHER

Radioactivity symbol