Capsion
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING METAL BOX LABEL AND LEAD POT LABEL |
1. NAME OF THE MEDICINAL PRODUCT
CAPSION
Sodium iodide [131I] capsule for therapy.
2. STATEMENT OF ACTIVE SUBSTANCE(S) |
Sodium iodide [131I], 50 to 3700 MBq per capsule at calibration date.
3. LIST OF EXCIPIENTS |
Anhydrous sodium pyrophosphate, Sodium thiosulphate, Gelatin capsule,
Disodium phosphate dihydrate, Sodium dihydrogen phosphate monohydrate,
Ascorbic acid and Water for injection.
4. PHARMACEUTICAL FORM AND CONTENTS |
Capsule, hard.
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN |
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY |
8. EXPIRY DATE |
EXP : DD/MM/YYYY
9. SPECIAL STORAGE CONDITIONS |
Do not store above 25°C. Store in the original package.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE |
For special warnings and precautions for elimination: read package insert before use.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER |
CIS bio international
BP 32
F-91192 GIF-SUR-YVETTE Cedex
12. MARKETING AUTHORISATION NUMBER(S) |
88/883/99-C
13. MANUFACTURER’S BATCH NUMBER |
Batch: XXXX
14. GENERAL CLASSIFICATION FOR SUPPLY |
Medicinal product subject to medical prescription.
15. 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 OF ADMINISTRATION
CAPSION
Sodium iodide [131I] capsule for therapy.
2. METHOD OF ADMINISTRATION
For oral use.
3. EXPIRY DATE |
EXP : {DD/MM/YYYY}
4. BATCH NUMBER |
Batch: {XXXXX}
5. CONTENTS BY UNIT |
MBq/capsule
SPECIAL STORAGE CONDITIONS |
Do not store above 25ºC. Store in the original package.
INSTRUCTION ON USE |
3
etP3925A07/2009