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Ecalta (anidulafungin) – Labelling - J02AX06

Updated on site: 06-Oct-2017

Medication nameEcalta
ATC CodeJ02AX06
Substanceanidulafungin
ManufacturerPfizer Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 100 mg anidulafungin.

The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.

3.LIST OF EXCIPIENTS

Excipients: fructose, mannitol, polysorbate 80, tartaric acid and NaOH and/or HCl for pH adjustment.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial

Powder for concentrate for solution for infusion

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Reconstitute the contents with water for injections and dilute before use.

Read the package leaflet before use.

For intravenous use only.

Rate of infusion should not exceed 1.1 mg/min

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 {MONTH – YYYY}

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

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

Pfizer Ltd

Ramsgate Road

Sandwich

KENT

CT13 9NJ United-Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/416/002

13.BATCH NUMBER

Lot {number}

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 label

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

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungin

Intravenous use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use

3.EXPIRY DATE

4.BATCH NUMBER

Lot {number}

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg

6.OTHER

Store in a refrigerator

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