Indium (In111) Oxinate

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Tin containing radioactive kit (radiolabel in lead shielding and buffer)

1. NAME OF THE MEDICINAL PRODUCT

37 MBq/mL; Radiopharmaceutical precursor.

Indium (In-111) chloride

DRN 4908

(= Code on vial)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Indium (In111) Oxinate: Indium (In-111) chloride 37 MBq/mL at [YYYY-MM-DD hh:mm] h CET, Oxine 0.025 mg

Tris: Tris buffer 0.2 M, pH 8.0

3. LIST OF EXCIPIENTS

Indium (In111) Oxinate: Sodium acetate trihydrate, acetic acid anhydrous, ferric chloride hexahydrate, sodium chloride, hydrochloric acid and water for injections.

Tris: Hydrochloric acid, trometamol and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

The tin contains two vials:

Indium (In111) Oxinate: Radiopharmaceutical precursor. 37 MBq/1 mL Tris: Solution for injection. 3 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after in-vitro labelling of blood cells. 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

9. SPECIÁL STORAGE CONDITIONS

Store below 25 °C.

10. SPECIÁL 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. After decay of radioactivity there are no special precautions for waste disposal.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mallinckrodt Medical BV, Westerduinweg 3, 1755 LE Petten, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

88/381/93-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

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Lead shielding In-111 oxinate

1. NAME OF THE MEDICINAL PRODUCT

Indium (In111) Oxinate

37 MBq/mL; Radiopharmaceutical precursor.

Indium (In-111) chloride

DRN 4908

(= Code on vial)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Indium (In-111) chloride 37 MBq/mL at [YYYY-MM-DD hh:mm] h CET, Oxine 0.025 mg

3. LIST OF EXCIPIENTS

Sodium acetate trihydrate, acetic acid anhydrous, ferric chloride hexahydrate, sodium chloride, hydrochloric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Radiopharmaceutical precursor. 37 MBq/1 mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after in-vitro labelling of blood cells. 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

9. SPECIÁL STORAGE CONDITIONS

Store below 25 °C.

10. SPECIÁL 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. After decay of radioactivity there are no special precautions for waste disposal.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mallinckrodt Medical BV, Westerduinweg 3, 1755 LE Petten, The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

88/381/93-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

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-111

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

DRN 4908 In-111

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

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

4. BATCH NUMBER

Lot: [00000/000]

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

37 MBq/1 mL

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

6. OTHER

Mallinckrodt Medical BV

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label: Tris buffer

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

Tris buffer 0.2 M pH 8.0 Solution for injection

2. METHOD OF ADMINISTRATION

For intravenous use after in-vitro labelling of blood cells.

3. EXPIRY DATE EXP [YYYY-MM-DD]

4. BATCH NUMBER

Lot[000000]

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 mL

6. OTHER