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DaTSCAN (ioflupane (123l)) – Labelling - V09AB03

Updated on site: 06-Oct-2017

Medication nameDaTSCAN
ATC CodeV09AB03
Substanceioflupane (123l)
ManufacturerGE Healthcare Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

5 ml presentation

1.NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection.

Ioflupane (123I)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

3.LIST OF EXCIPIENTS

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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: 20 h post-ref.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Handling and disposal – see package leaflet.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GE Healthcare Limited

Little Chalfont

HP7 9NA

UK

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/135/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS FOR USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

5 ml presentation

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

DaTSCAN 74 MBq/ml solution for injection.

Ioflupane (123I)

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP: 20 h post-ref.

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6.OTHER

GE Healthcare B.V.

Den Dolech 2

NL-5612 AZ, Eindhoven

The Netherlands

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

2.5 ml presentation

1. NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

3. LIST OF EXCIPIENTS

5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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: 7 h post-ref.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Handling and disposal – see package leaflet.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GE Healthcare Limited

Little Chalfont

HP7 9NA

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/135/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS FOR USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

2.5 ml presentation

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

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP: 7 h post-ref.

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

6. OTHER

GE Healthcare B.V.

Den Dolech 2

NL-5612 AZ, Eindhoven

The Netherlands

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