Příbalový Leták

Adenocor

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.


18. UNIQUE IDENTIFIER -

HUMAN READABLE DATA

PC:

SN:

NN:

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


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