Indium (111 in) dtpa Obalová informace

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Tin and lead jar

1. NAME OF THE MEDICINAL PRODUCT

Indium (In-111) DTPA 37 MBq/mL solution for injection
DRN 4916 (= Code on vial)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Indium (In-111) pentetate y MBq in x mL at ART
Pentetic acid 0.1 mg/mL

y MBq [YYYY-MM-DD hh:mm] h CET

3. LIST OF EXCIPIENTS

Contains also: calcium chloride dihydrate, sodium chloride, disodium phosphate dodecahydrate,
hydrochloric acid, sodium hydroxide and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

multidose vial of 37 MBq/mL in 1 mL.
multidose vial of 37 MBq/mL in 0.5 mL.
Solution for injection.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intrathecal 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

First use: [YYYY-MM-DD hh:mm] h CET

8. EXPIRY DATE

EXP: [YYYY-MM-DD hh:mm] h CET
If multi-dose use is intented, each aliquot should be removed under aseptic conditions and within one
working day. The vial should be stored between 2°C-8°C after removal of the first aliquot.


9. SPECIAL STORAGE CONDITIONS

Store below 25 °C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

Radioactive waste disposal should be in accordance with national regulations.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Curium Netherlands BV, Westerduinweg 3, 1755 LE Petten, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

88/761/93-C

13. BATCH NUMBER

Lot: [12345]

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE



16. INFORMATION IN BRAILLE

[Justification for not including Braille accepted - Indium (In-111) is only intended for administration by
healthcare professionals]

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable.



MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
In case of radiopharmaceuticals the vial should be labelled in accordance to the article 66(3) of
Directive 2001/83.

Vial label: In-

1. THE NAME OR CODE OF THE MEDICINAL PRODUCT, INCLUDING THE NAME OR
CHEMICAL SYMBOL OF THE RADIONUCLIDE

DRN 4916 In-111

2. THE AMOUNT OF RADIOACTIVITY

y MBq/x mL
[YYYY-MM-DD hh:mm] h CET

3. EXPIRY DATE

EXP: [YYYY-MM-DD hh:mm] h CET

4. BATCH NUMBER

Lot: [00000/000]

5. THE NAME OF THE MANUFACTURER

Curium Netherlands B.V.

6. THE INTERNATIONAL SYMBOL FOR RADIOACTIVITY





With y = 18.5 or 37 and x, z = 0.5 or 1.