Thallous (Tl201) Chloride Injection

PARTICULARS TO APPEAR ON THE OUTER PACKAGING tin Container

1. NAME OF THE MEDICINAL PRODUCT

Thallous (TI201) Chloride Injection 37 MBq/ml, solution for injection

DRN 8103 (Code of the product)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Contains:

Thallous (Tl201) Chloride 37 MBq/ml

3. LIST OF EXCIPIENTS

sodium chloride, sodium hydroxide, hydrochloric acid, 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.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.

10. SPECIÁL 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

Mallinckrodt 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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS injection vial, lead jar

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION