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Qtern (saxagliptin / dapagliflozin propanediol...) – Labelling - A10BD21

Updated on site: 09-Oct-2017

Medication nameQtern
ATC CodeA10BD21
Substancesaxagliptin / dapagliflozin propanediol monohydrate
ManufacturerAstra Zeneca AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Qtern 5 mg/10 mg film-coated tablets saxagliptin/dapagliflozin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

3.LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

98 film-coated tablets

30 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1108/001 14 film-coated tablets

EU/1/16/1108/002 28 film-coated tablets

EU/1/16/1108/003 98 film-coated tablets

EU/1/16/1108/004 30 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

qtern 5 mg/10 mg

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 BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Qtern 5 mg/10 mg tablets saxagliptin/dapagliflozin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Qtern 5 mg/10 mg tablets saxagliptin/dapagliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Mon. Tue. Wed. Thu. Fri. Sat. Sun.

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