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Scintimun (besilesomab) – Labelling - V09HA03

Updated on site: 10-Oct-2017

Medication nameScintimun
ATC CodeV09HA03
Substancebesilesomab
ManufacturerCIS bio international  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

contains Blue Box

1.NAME OF THE MEDICINAL PRODUCT

Scintimun 1 mg kit for radiopharmaceutical preparation besilesomab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial of Scintimun contains 1 mg of besilesomab

3.LIST OF EXCIPIENTS

Scintimun

Excipients: Sodium dihydrogen phosphate anhydrous, disodium monohydrogen phosphate anhydrous, sorbitol, under nitrogen atmosphere.

Solvent for Scintimun

1, 1, 3, 3-propane tetraphosphonic acid tetrasodium salt dihydrate, stannous chloride dihydrate, sodium hydroxide, hydrochloric acid, nitrogen.

Read the leaflet for further information before use.

4.PHARMACEUTICAL FORM AND CONTENTS

Kit for radiopharmaceutical preparation

Contains one multidose vial Scintimun and one vial solvent for Scintimun

Contains two multidose vials Scintimun and two vials solvent for Scintimun

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use

Reconstitute Scintimun with its solvent first and then radiolabel with a sodium pertechnetate (99mTc) solution.

Read the package leaflet before use.

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

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

Use within 3 hours after radiolabelling.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 °C – 8 °C).

Keep the vial in the outer carton in order to protect from light.

Do not store the reconstituted and radiolabelled product above 25 °C.

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

Dispose of radioactive waste in accordance with local regulations.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

CIS bio international

B.P.32

F-91192 Gif-sur-Yvette Cedex

France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/602/001 one multidose vial Scintimun and one vial solvent for Scintimun EU/1/09/602/002 two multidose vials Scintimun and two vials solvent for Scintimun

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

GLASS VIAL Scintimun

no Blue Box included

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

Scintimun 1 mg kit for radiopharmaceutical preparation

Besilesomab

Intravenous use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

Use within 3 hours after radiolabelling.

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 mg

6.OTHER

CIS bio international

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

GLASS VIAL Solvent for Scintimun

no Blue Box included

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

Solvent for Scintimun

2. METHOD OF ADMINISTRATION

Not intended for direct application to patients.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.82 mg

6. OTHER

CIS bio international

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Additional label after reconstitution and radiolabelling with sodium pertechnetate (99mTc) solution

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

(99mTc)- Scintimun

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

99mTc

MBq ml

hour/date

6. OTHER

CIS bio international

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