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Levemir (insulin detemir) – Labelling - A10AE05

Updated on site: 08-Oct-2017

Medication nameLevemir
ATC CodeA10AE05
Substanceinsulin detemir
ManufacturerNovo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (CARTRIDGE. Penfill)

1.NAME OF THE MEDICINAL PRODUCT

Levemir 100 units/ml

Solution for injection in cartridge

Insulin detemir

2.STATEMENT OF ACTIVE SUBSTANCE

1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg). 1 cartridge contains 3 ml equivalent to 300 units,

3.LIST OF EXCIPIENTS

glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in cartridge. Penfill.

1 x 3 ml cartridge

5 x 3 ml cartridges

10 x 3 ml cartridges

5.METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

Use only solution if water clear, colourless and aqueous

For use by one person only

8.EXPIRY DATE

EXP

During use: Use within 6 weeks

9.SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator (2°C to 8°C)

During use: Do not refrigerate. Store below 30°C

Do not freeze

Keep the cartridge in the outer carton in order to protect it from light

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Discard the needle after each injection

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

12.MARKETING AUTHORISATION NUMBERS

EU/1/04/278/001 1 cartridge of 3 ml

EU/1/04/278/002 5 cartridges of 3 ml

EU/1/04/278/003 10 cartridges of 3 ml

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Levemir Penfill

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

LABEL (CARTRIDGE. Penfill)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Levemir 100 units/ml

Solution for injection

Insulin detemir

SC use

2.METHOD OF ADMINISTRATION

Penfill

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (PRE-FILLED PEN. FlexPen)

1. NAME OF THE MEDICINAL PRODUCT

Levemir 100 units/ml

Solution for injection in pre-filled pen

Insulin detemir

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units,

3. LIST OF EXCIPIENTS

glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen. FlexPen.

1 x 3 ml pre-filled pen

5 x 3 ml pre-filled pens

10 x 3 ml pre-filled pens

1 x 3 ml pre-filled pen + 7 NovoFine needles 1 x 3 ml pre-filled pen + 7 NovoTwist needles

5. METHOD AND ROUTE OF ADMINISTRATION

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

Use only solution if water clear, colourless and aqueous For use by one person only

Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm

8. EXPIRY DATE

EXP

During use: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator (2°C to 8°C)

During use: Store below 30°C. Can be stored in a refrigerator (2°C to 8°C) Do not freeze

Keep the cap on in order to protect it from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Discard the needle after each injection

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/04/278/004 1 pen of 3 ml

EU/1/04/278/005 5 pens of 3 ml

EU/1/04/278/006 10 pens of 3 ml

EU/1/04/278/010 1 pen of 3 ml and 7 NovoFine needles

EU/1/04/278/011 1 pen of 3 ml and 7 NovoTwist needles

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Levemir FlexPen

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

PEN LABEL (PRE-FILLED PEN. FlexPen)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Levemir 100 units/ml

Solution for injection

Insulin detemir

SC use

2. METHOD OF ADMINISTRATION

FlexPen

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (PRE-FILLED PEN. InnoLet)

1. NAME OF THE MEDICINAL PRODUCT

Levemir 100 units/ml

Solution for injection in pre-filled pen

Insulin detemir

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units,

3. LIST OF EXCIPIENTS

glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen. InnoLet.

1 x 3 ml pre-filled pen

5 x 3 ml pre-filled pens

10 x 3 ml pre-filled pens

5. METHOD AND ROUTE OF ADMINISTRATION

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

Use only solution if water clear, colourless and aqueous For use by one person only

Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm

8. EXPIRY DATE

EXP

During use: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator (2°C to 8°C)

During use: Do not refrigerate. Store below 30°C

Do not freeze

Keep the cap on in order to protect it from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Discard the needle after each injection

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/04/278/007 1 pen of 3 ml

EU/1/04/278/008 5 pens of 3 ml

EU/1/04/278/009 10 pens of 3 ml

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Levemir InnoLet

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

PEN LABEL (PRE-FILLED PEN. InnoLet)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Levemir 100 units/ml

Solution for injection

Insulin detemir

SC use

2. METHOD OF ADMINISTRATION

InnoLet

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (PRE-FILLED PEN. FlexTouch)

1. NAME OF THE MEDICINAL PRODUCT

Levemir 100 units/ml

Solution for injection in pre-filled pen

Insulin detemir

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units,

3. LIST OF EXCIPIENTS

glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen. FlexTouch.

1 x 3 ml pre-filled pen

5 x 3 ml pre-filled pens

2 x (5 x 3 ml) pre-filled pens

1 x 3 ml pre-filled pen + 7 NovoFine needles 1 x 3 ml pre-filled pen + 7 NovoTwist needles

5. METHOD AND ROUTE OF ADMINISTRATION

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

Use only solution if water clear, colourless and aqueous For use by one person only

Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm

8. EXPIRY DATE

EXP

During use: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator (2°C to 8°C)

During use: Store below 30°C. Can be stored in a refrigerator (2°C to 8°C)

Do not freeze

Keep the cap on in order to protect it from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Discard the needle after each injection

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/04/278/012 1 pen of 3 ml EU/1/04/278/013 5 pens of 3 ml

EU/1/04/278/014 5 pens of 3 ml. This is part of a multipack of 10 pens and not for sale as individual pens

EU/1/04/278/015 1 pen of 3 ml and 7 NovoFine needles EU/1/04/278/016 1 pen of 3 ml and 7 NovoTwist needles

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Levemir FlexTouch

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER WRAPPER LABEL ON MULTIPACKS (FlexTouch)

1. NAME OF THE MEDICINAL PRODUCT

Levemir 100 units/ml

Solution for injection in pre-filled pen

Insulin detemir

SC use

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units,

3. LIST OF EXCIPIENTS

glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen. FlexTouch.

2 x (5 x 3 ml). This is a multipack of 10 pre-filled pens and not for sale as individual pre-filled pens

5. METHOD AND ROUTE OF ADMINISTRATION

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

Use only solution if water clear, colourless and aqueous For use by one person only

Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm

8. EXPIRY DATE

EXP

During use: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator (2°C to 8°C)

During use: Store below 30°C. Can be stored in a refrigerator (2°C to 8°C) Do not freeze

Keep the cap on in order to protect it from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Discard the needle after each injection

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

12. MARKETING AUTHORISATION NUMBER

EU/1/04/278/014

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Levemir FlexTouch

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

PEN LABEL (PRE-FILLED PEN. FlexTouch)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Levemir 100 units/ml

Solution for injection

Insulin detemir

SC use

2. METHOD OF ADMINISTRATION

FlexTouch

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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