Ermm-1
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. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C. Store in the original packaging
After first withdrawing, store in a refrigerator (2 °C - 8 °C) and use within 8 hours.
10. SPECIAL 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. 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
2. METHOD OF ADMINISTRATION
For intra-articular injection.
3. EXPIRY DATE
EXP: MM/AAAA
4. BATCH NUMBER
Batch N°
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Vol :..... ml
.....MBq/vial {JJ/MM/AAAA} (12h CET)
.....111 MBq/ml {JJ/MM/AAAA} (12 h CET)
6. OTHER
Radioactivity symbol
