Thallous (T1 201) Chloride Injection
Registrace léku
| Kód | 0066390 ( ) |
|---|---|
| Registrační číslo | 88/ 211/93-C |
| Název | THALLOUS (T1 201) CHLORIDE INJECTION |
| Režim prodeje | na lékařský předpis |
| Stav registrace | registrovaný léčivý přípravek |
| Držitel registrace | Mallinckrodt Medical B.V., Le Petten, Nizozemsko |
| ATC klasifikace |
|
Varianty
| Kód | Náz. | Forma |
|---|---|---|
| 0066390 | INJ SOL 1X1.7ML/63MB EXP:D | Injekční roztok, Injekce |
| 0066393 | INJ SOL 370MB 37MB/ML EXP:D | Injekční roztok, Injekce |
| 0066391 | INJ SOL 85MB 37MB/ML EXP:D | Injekční roztok, Injekce |
| 0066392 | INJ SOL 213MB 37MB/ML EXP:D | Injekční roztok, Injekce |
Informace na obalu
PARTICULARS TO APPEAR ON THE OUTER PACKAGING tin container 1.
NAME OF THE MEDICINAL PRODUCT
Thallous (Tl201) Chloride Injection, 37 MBq/ml, solution for injection. 2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Contains: Thallous (Tl201) Chloride 37 MBq/ml 3.
LIST OF EXCIPIENTS
sodium chloride, 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: After aseptic removal of the first aliquot the product is stable for 8 hours stored at 2°C-8°C.
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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 product or waste material should be disposed of in accordance with local requirements. 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mallinckrodr Medical B.V. Westerduinweg 3 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 medicinal prescription. 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE Nevyžaduje se – odůvodnění přijato.
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS injection vial 1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Thallous (Tl201) Chloride Injection, 37 MBq/ml, solution for injection Intravenous use. 2.
METHOD OF ADMINISTRATION
Intravenous use 3.
EXPIRY DATE
EXP: 4.
BATCH NUMBER
Lot: 5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Thallous (Tl201) Chloride 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 6.
OTHER