PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Tin containing radio-active kit (radiolabel in lead shielding and labeling substance)

1. NAME OF THE MEDICINAL PRODUCT

Octreoscan

Kit for preparation of ^mIn-Pentetreotide 111 MBq/ ml .

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Vial A: Indium (¹¹¹In) Chloride 111 MBq/ml (as 122 MBq/1.1ml) at ART Vial B: Pentetreotide 10 microgram

3. LIST OF EXCIPIENTS

Vial A: hydrochloric acid, water for injection and ferric chloride hexahydrate.

Vial B: sodium citrate dihydrate, citric acid monohydrate, inositol and gentisic acid.

4. PHARMACEUTICAL FORM AND CONTENTS

Kit for preparation. The kit consists of two vials: Vial A: Radiopharmaceutical precursor Vial B: Powder for solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE_

EXP [DD MMM YYYY]

After reconstitution and labeling: expiry 6 hours

9. SPECIAL STORAGE CONDITIONS

Before and after reconstitution store below 25°C

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

12. MARKETING AUTHORISATION NUMBER(S)

14. GENERAL CLASSIFICATION FOR SUPPLY

16. INFORMATION IN BRAILLE

Vial label: Vial A

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

Octreoscan Vial A Radiopharmaceutical precursor

2. METHOD OF ADMINISTRATION

for labelling with Vial B

3. EXPIRY DATE

EXP [DD MMM YY]

4. BATCH NUMBER

Lot [00000/000]

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Indium (In111) chloride ,122 MBq in 1.1 ml (111 MBq/ml) [DD MMM YYYY] 18:00h.CET

6. OTHER_

Mallinckrodt Medical BV

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

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT