PARTICULARS TO APPEAR ON THE OUTER PACKAGING outer packaging

1. NAME OF THE MEDICINAL PRODUCT

Adenocor 3 mg/ml

Solution for injection Adenosine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 6 mg adenosine in 2 ml of a 0,9% w/v solution of sodium chloride in Water for Injections.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 6 vials 6 mg/2 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Always read the leaflet before using this medicine. Vials for single use only.

6.    SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the reach and sight of children.

7.    OTHER SPECIAL WARNING(S), IF NECESSARY

For rapid Intravenous Injection only See enclosed leaflet for directions.

8. EXPIRY DATE

EXP

9. SPECIÁL STORAGE CONDITIONS

Do not refrigerate.

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

Any portion of the vial not used at once should be discarded.

11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MA Holder:

Sanofi

One Onslow Street Guildford, Surrey,

GU1 4YS, UK

Label:

Držitel rozhodnutí o registraci v ČR: sanofi-aventis, s.r.o.

Praha, Česká republika

12. MARKETING AUTHORISATION NUMBER(S)

Label:

Reg. č.: 13/574/95-C

13.    BATCH NUMBER

BN:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ampoule label

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

Adenocor 3 mg/ml

Solution for injection Adenosine

2. METHOD OF ADMINISTRATION

For rapid IV injection only. For single use only.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

BN:

5.    CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6 mg/2 ml

6. OTHER

logo Sanofi