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Abasaglar (Abasria) (insulin glargine) – Labelling - A10AE04

Updated on site: 11-Jul-2017

Medication nameAbasaglar (Abasria)
ATC CodeA10AE04
Substanceinsulin glargine
ManufacturerEli Lilly Regional Operations GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Cartridge. Pack of 1, 2 , 5 and 10

1.NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a cartridge

Insulin glargine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).

3.LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 cartridge of 3 mL.

2 cartridges of 3 mL.

5 cartridges of 3 mL.

10 cartridges of 3 mL

5.METHOD AND ROUTE(S) OF ADMINISTRATION

These cartridges are for use with a Lilly 3 mL pen only.

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 WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

Discard 28 days after first use.

9.SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/001

 

 

 

1 cartridge

EU/1/14/944/002

2 cartridges

 

 

EU/1/14/944/003

5 cartridges

 

EU/1/14/944/009

10 cartridges

 

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ABASAGLAR

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without blue box) component of multipack- Cartridge

1. NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a cartridge

Insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 unitsinsulin glargine (equivalent to 3.64 mg).

3. LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 5 cartridges of 3 mL. Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

These cartridges are for use with a Lilly 3 mL pen only.

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 WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Discard 28 days after first use.

9. SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ABASAGLAR

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack- Cartridge

1. NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a cartridge

Insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).

3. LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 10 (2 packs of 5) cartridges of 3 mL.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

These cartridges are for use with a Lilly 3 mL pen only.

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 WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Discard 28 days after first use.

9. SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ABASAGLAR

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – KwikPen. Pack of 1, 2 and 5

1. NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen

Insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).

3. LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen

1 pen of 3 mL.

2 pens of 3 mL.

5 pens of 3 mL.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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 WARNING(S), IF NECESSARY

Now dials up to 80 units

8. EXPIRY DATE

EXP

Discard pen 28 days after first use.

9. SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

Recap the pen after use 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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/005

 

 

1 pen

EU/1/14/944/006

2 pens

 

EU/1/14/944/007

5 pens

EU/1/14/944/010

1 pen

 

EU/1/14/944/011

2 pens

 

EU/1/14/944/012

5 pens

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ABASAGLAR

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON (without blue box) component of a multipack – KwikPen

1. NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen

Insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).

3. LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen

Multipack: 5 pens of 3 mL. Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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 WARNING(S), IF NECESSARY

Now dials up to 80 units

8. EXPIRY DATE

EXP

Discard pen 28 days after first use.

9. SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

Recap the pen after use 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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/008

EU/1/14/944/013

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ABASAGLAR

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1. NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen

Insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL contains 100 units insulin glargine (equivalent to 3.64 mg).

3. LIST OF EXCIPIENTS

Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen

Multipack: 10 (2 packs of 5) pens of 3 mL.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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 WARNING(S), IF NECESSARY

Now dials up to 80 units

8. EXPIRY DATE

EXP

Discard pen 28 days after first use.

9. SPECIAL STORAGE CONDITIONS

Before use:

Store in a refrigerator.

Do not freeze.

Store in original package to protect from light.

In use:

Store below 30 º C.

Do not refrigerate or freeze.

Recap the pen after use 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

Eli Lilly Regional Operations GmbH.,

Kölblgasse 8-10,

1030, Vienna,

Austria.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/944/008

EU/1/14/944/013

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ABASAGLAR

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE LABEL

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

ABASAGLAR 100 units/mL, injection

Insulin glargine

SC use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 mL

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL TEXT –KwikPen

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

ABASAGLAR 100 units/mL injection

KwikPen

Insulin glargine

SC use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 mL

6. OTHER

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