Příbalový Leták

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

etP3925A

07/2009