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DuoTrav (travoprost / timolol) – Labelling - S01ED51

Updated on site: 06-Oct-2017

Medication nameDuoTrav
ATC CodeS01ED51
Substancetravoprost / timolol
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR SINGLE BOTTLE 2.5 mL + CARTON FOR 3 x 2.5 mL BOTTLES + CARTON FOR 6 x 2.5 mL BOTTLES

1.NAME OF THE MEDICINAL PRODUCT

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution. travoprost/timolol.

2.STATEMENT OF ACTIVE SUBSTANCE

Each ml of solution contains 40 micrograms travoprost and 5 mg timolol (as timolol maleate).

3.LIST OF EXCIPIENTS

Contains:Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution. 1 x 2.5 mL.

3 x 2.5 mL.

6 x 2.5 mL.

5.METHOD AND ROUTE OF ADMINISTRATION

Ocular Use.

Read the package leaflet before use.

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT 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

Do not store above 30°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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom.

12.MARKETING AUTHORISATION NUMBERS

EU/1/06/338/001 1 x 2.5 ml. – PP Bottle

EU/1/06/338/002 3 x 2.5 ml. – PP Bottle

EU/1/06/338/003 6 x 2.5 ml. – PP Bottle

EU/1/06/338/004 1 x 2.5 ml. – LDPE Bottle

EU/1/06/338/005 3 x 2.5 ml. – LDPE Bottle

EU/1/06/338/006 6 x 2.5 ml. – LDPE Bottle

13.BATCH NUMBER

Lot.

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16 INFORMATION IN BRAILLE

duotrav

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops. travoprost/timolol.

Ocular use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use. <Open here>

3.EXPIRY DATE

EXP.

Discard 4 weeks after first opening.

Opened.

4.BATCH NUMBER

Lot.

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 mL.

6 OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

OVERWRAP

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops.

travoprost/timolol.

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP.

Discard 4 weeks after first opening.

4. BATCH NUMBER

Lot.

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 mL.

6 OTHER

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