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Yellox (bromfenac sodium sesquihydrate) – Labelling - S01BC11

Updated on site: 11-Oct-2017

Medication nameYellox
ATC CodeS01BC11
Substancebromfenac sodium sesquihydrate
ManufacturerPharmaSwiss Ceska Republika s.r.o

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR SINGLE BOTTLE 5 ML

1.NAME OF THE MEDICINAL PRODUCT

Yellox 0.9 mg/ml eye drops solution bromfenac

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms bromfenac.

3.LIST OF EXCIPIENTS

Boric acid, borax, sodium sulphite anhydrous (E221) (see the package leaflet for further information), tyloxapol, povidone, disodium edetate, benzalkonium chloride (see the package leaflet for further information), water for injections, sodium hydroxide (for pH adjustment)

4.PHARMACEUTICAL FORM AND CONTENTS

eye drops, solution 1x5 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Ocular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHTAND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

Discard any unused contents 4 weeks after first opening.

Opened:

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

PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c

17000 Praha 7

Czech Republic

12.MARKETING AUTHORISATION NUMBER

EU/1/11/692/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Yellox

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

BOTTLE LABEL

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

Yellox 0.9 mg/ ml eye drops, solution bromfenac

Ocular use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6.OTHER

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