Thallous (tl201) chloride injection
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
tin label and lead pot
1. NAME OF THE MEDICINAL PRODUCT
Thallous (Tl201) Chloride Injection,37 MBq/ml, solution for injection
DRN 8103 (Code of the product) Thallous (Tl-201) Chloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Contains:
Thallous (Tl-201) Chloride 37 MBq/ml,
3. LIST OF EXCIPIENTS
sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
4. PHARMACEUTICAL FORM AND CONTENTS
Solution for injection
63 MBq in 1.7 ml at ART
85 MBq in 2.3 ml at ART
213 MBq in 5.8 ml at ART
370 MBq in 10.0 ml at ART
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For multi-dose use.
Intravenous use.
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 the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP: [YYYY-MM-DD hh:mm] CET
After aseptic removal of the first aliquot the product is stable for 8 hours stored at 2 °C-8 °C.
OB_Thallous Chloride_343545-21 9. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS
DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Curium Netherlands B.V.
Westerduinweg 1755 LE Petten
The Netherlands
12. MARKETING AUTHORISATION NUMBER(S)
88/211/93-C
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nevyžaduje se – odůvodnění přijato.
17. UNIQUE IDENTIFIER – 2D BARCODE
Not applicable
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
Not applicable
OB_Thallous Chloride_343545-21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
vial
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Thallous (Tl201) Chloride Injection, 37 MBq/ml, solution for injection
Thallous (Tl201) Chloride
8103 (Code of the product)
Intravenous use.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP:
4. BATCH NUMBER
Lot:
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
63 MBq in 1.7 ml at ART
85 MBq in 2.3 ml at ART
213 MBq in 5.8 ml at ART
370 MBq in 10.0 ml at ART
6. OTHER
Curium Netherlands B.V.