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Xydalba (dalbavancin hcl) – Labelling - J01XA04

Updated on site: 11-Oct-2017

Medication nameXydalba
ATC CodeJ01XA04
Substancedalbavancin hcl
ManufacturerAllergan Pharmaceuticals International Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1.NAME OF THE MEDICINAL PRODUCT

Xydalba 500 mg powder for concentrate for solution for infusion

Dalbavancin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin. After reconstitution each ml contains 20 mg dalbavancin.

3.LIST OF EXCIPIENTS

Mannitol (E421),

Lactose monohydrate,

Sodium hydroxide and/or hydrochloric acid (for pH adjustment)

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion

1 vial

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

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

Allergan Pharmaceuticals International Ltd.,

Clonshaugh Industrial Estate, Coolock,

Dublin 17,

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/986/001

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

Vial label

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

Xydalba 500 mg powder for concentrate Dalbavancin

intravenous use after reconstitution and dilution

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

Allergan Pharmaceuticals International Ltd.

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