Příbalový Leták

Octreoscan

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


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


[To be completed nationally]

12. MARKETING AUTHORISATION NUMBER(S)


[To be completed nationally]

13. BATCH NUMBER

Lot [12345]

14. GENERAL CLASSIFICATION FOR SUPPLY


[To be completed nationally]

15. INSTRUCTIONS ON USE_

The sterile needle included in the pack is to be ušed for the reconstitution.


16. INFORMATION IN BRAILLE


Octreoscan is only intended for administration by health care professionals

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


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

OctreoScan Vial B

Powder for solution for injection

2. METHOD OF ADMINISTRATION

Intravenous use after labelling with Vial A

3. EXPIRY DATE_

EXP [DD MMM YYYY]

After reconstitution: expiry 6 Hours

4. BATCH NUMBER

Lot [000000]

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT


Pentetreotide 10 microgram reaction vial

6. OTHER_

Mallinckrodt Medical BV

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