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Neuraceq (florbetaben (18F)) – Labelling - V09AX06

Updated on site: 08-Oct-2017

Medication nameNeuraceq
ATC CodeV09AX06
Substanceflorbetaben (18F)
ManufacturerPiramal Imaging Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

METALLIC BOX (with Blue Box)

1.NAME OF THE MEDICINAL PRODUCT

Neuraceq 300 MBq/mL solution for injection

Florbetaben (18F)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration.

3.LIST OF EXCIPIENTS

Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

One multidose vial

Customer ref

Activity: {XXX} MBq in {XX} mL

ToC: {DDMMYYYY} {XX}h{XX} Time zone

Volume: {XX} mL

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use.

Multidose.

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

Radioactive material.

Alliance Medical Molecular Imaging Ltd., UK

BV Cyclotron VU, the Netherlands

Cis Bio International, Nancy, France

Cis Bio International, Nîmes, France

Cis Bio International, Paris, France

Cis Bio International, Rennes, France

Cis Bio International, Pessac, France

Eckert & Ziegler EURO-PET Berlin GmbH, Germany

PET Net Muenchen GmbH, Germany

Eckert & Ziegler EURO-PET Warszawa Sp. z o.o., Poland

Eckert & Ziegler EURO-PET Koeln/Bonn GmbH, Germany

IBA Molecular Italy S.R.L., Monza, Italy

IBA Molecular Italy S.R.L., Rome, Italy

IBA Molecular Italy S.R.L., Udine, Italy

IBA Molecular Spain, S.A., Seville, Spain

IBA Molecular Spain, S.A., Madrid, Spain

Seibersdorf Labor GmbH, Austria

BetaPlus Pharma SA, Brussels, Belgium

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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

Any unused material should be disposed of in accordance with national regulations.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Piramal Imaging Ltd., Langstone Tech. Park, Havant PO9 1SA, UK

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/906/001

13.BATCH NUMBER

Lot

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 POT (without Blue Box)

1. NAME OF THE MEDICINAL PRODUCT

Neuraceq 300 MBq/mL solution for injection

Florbetaben (18F)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration.

3. LIST OF EXCIPIENTS

Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

One multi-dose vial

Activity: {XXX} MBq in {XX} mL

ToC: {DDMMYYYY} {XX}h{XX} Time zone

Volume: {XX} mL

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use.

Multidose.

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

Radioactive material.

Alliance Medical Molecular Imaging Ltd., UK

BV Cyclotron VU, the Netherlands

Cis Bio International, Nancy, France

Cis Bio International, Nîmes, France

Cis Bio International, Paris, France

Cis Bio International, Rennes, France

Cis Bio International, Pessac, France

Eckert & Ziegler EURO-PET Berlin GmbH, Germany

PET Net Muenchen GmbH, Germany

Eckert & Ziegler EURO-PET Warszawa Sp. z o.o., Poland

Eckert & Ziegler EURO-PET Koeln/Bonn GmbH, Germany

IBA Molecular Italy S.R.L., Monza, Italy

IBA Molecular Italy S.R.L., Rome, Italy

IBA Molecular Italy S.R.L., Udine, Italy

IBA Molecular Spain, S.A., Seville, Spain

IBA Molecular Spain, S.A., Madrid, Spain

Seibersdorf Labor GmbH, Austria

BetaPlus Pharma SA, Brussels, Belgium

8. EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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

Piramal Imaging Ltd., Langstone Tech. Park, Havant PO9 1SA, UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/906/001

13. BATCH NUMBER

Lot

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

VIAL

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

Neuraceq 300 MBq/mL solution for injection

Florbetaben (18F)

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP: ToC + 6 h

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Act.: ≤ 3000 MBq at ToC (see outer label)

6.OTHER

Radioactive material.

Alliance Medical Molecular Imaging Ltd., UK

BV Cyclotron VU, the Netherlands

Cis Bio International, Nancy, France

Cis Bio International, Nîmes, France

Cis Bio International, Paris, France

Cis Bio International, Rennes, France

Cis Bio International, Pessac, France

Eckert & Ziegler EURO-PET Berlin GmbH, Germany

PET Net Muenchen GmbH, Germany

Eckert & Ziegler EURO-PET Warszawa Sp. z o.o., Poland

Eckert & Ziegler EURO-PET Koeln/Bonn GmbH, Germany IBA Molecular Italy S.R.L., Monza, Italy

IBA Molecular Italy S.R.L., Rome, Italy

IBA Molecular Italy S.R.L., Udine, Italy

IBA Molecular Spain, S.A., Seville, Spain

IBA Molecular Spain, S.A., Madrid, Spain

Seibersdorf Labor GmbH, Austria

BetaPlus Pharma SA, Brussels, Belgium

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