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Simbrinza (brinzolamide / brimonidine tartrate) – Labelling - S01EC54

Updated on site: 10-Oct-2017

Medication nameSimbrinza
ATC CodeS01EC54
Substancebrinzolamide / brimonidine tartrate
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON 5 ml BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

SIMBRINZA 10 mg/ml + 2 mg/ml eye drops, suspension

Brinzolamide/brimonidine tartrate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml of suspension contains 10 mg brinzolamide and 2 mg brimonidine tartrate

3.LIST OF EXCIPIENTS

Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.

See the package leaflet for further details.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, suspension 1 x 5 ml

3 x 5 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Ocular use

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

Discard 4 weeks after first opening.

Opened:

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/933/001 1 x 5 ml

EU/1/14/933/002 3 x 5 ml

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

simbrinza

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

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

SIMBRINZA 10 mg/ml + 2 mg/ml eye drops

Brinzolamide/brimonidine tartrate

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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