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Saxenda (liraglutide) – Labelling - A10BX07

Updated on site: 10-Oct-2017

Medication nameSaxenda
ATC CodeA10BX07
Substanceliraglutide
ManufacturerNovo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Saxenda 6 mg/ml solution for injection in pre-filled pen

Liraglutide

2.STATEMENT OF ACTIVE SUBSTANCE

1 ml contains 6 mg of liraglutide. One pre-filled pen contains 18 mg liraglutide

3.LIST OF EXCIPIENTS

Excipients: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 pen

3 pens

5 pens

Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg

5.METHOD AND ROUTE OF ADMINISTRATION

The pen is designed to be used with NovoFine or NovoTwist disposable needles

Needles are not included

Read the package leaflet before use Subcutaneous 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 WARNINGS, IF NECESSARY

Do not store the pen with a needle attached

For use by one person only

8.EXPIRY DATE

EXP

Discard pen 1 month after first use

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

After first use of the pen, store below 30°C or in a refrigerator

Keep the pen cap on in order to protect from light

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12.MARKETING AUTHORISATION NUMBER

EU/1/15/992/001 1 x 3 ml

EU/1/15/992/002 3 x 3 ml

EU/1/15/992/003 5 x 3 ml

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Saxenda

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

PRE-FILLED PEN LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Saxenda 6 mg/ml injection

Liraglutide

SC use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml

6.OTHER

Novo Nordisk A/S

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