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Invanz (ertapenem sodium) – Labelling - J01DH03

Updated on site: 08-Oct-2017

Medication nameInvanz
ATC CodeJ01DH03
Substanceertapenem sodium
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

INVANZ 1 g powder for concentrate for solution for infusion

Ertapenem

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains: 1.0 g ertapenem (as sodium).

3.LIST OF EXCIPIENTS

Sodium bicarbonate (E500); sodium hydroxide (E524) to adjust pH to 7.5.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion 1 vial

10 vials

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use after reconstitution and dilution.

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 sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25 C

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

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/216/001 1 vial

EU/1/02/216/002 10 vials

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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

VIAL LABEL

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

INVANZ 1 g powder for concentrate for solution for infusion

Ertapenem

Intravenous use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 g

6.OTHER

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