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Actraphane (insulin human) – Labelling - A10AD01

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (VIAL)

1.NAME OF THE MEDICINAL PRODUCT

Actraphane 30 40 IU/ml

Suspension for injection

Insulin human

2.STATEMENT OF ACTIVE SUBSTANCE

1 vial contains 10 ml equivalent to 400 IU. 1 ml suspension contains 40 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 1.4 mg),

3.LIST OF EXCIPIENTS

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

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 vial of 10 ml

5 vials of 10 ml

Multipack: 5 packs of 1 x 10 ml vial and not for sale as individual vials

5.METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

8.EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9.SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

During use: Store below 25°C. Do not refrigerate or freeze

Keep the vial in the outer carton 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

Discard the needle and syringe 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/1/02/229/001

 

 

 

 

 

1 vial of 10

ml

EU/1/02/229/002

5 vials of 10

ml

 

EU/1/02/229/036

Multipack: 5 packs of 1 x 10 ml vial and not for sale as individual vials

13.BATCH NUMBER

Batch:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Actraphane 30 40

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 (VIAL)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Actraphane 30 40 IU/ml

Suspension for injection

Insulin human

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP/

4.BATCH NUMBER

Batch:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6.OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (VIAL)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 100 IU/ml

Suspension for injection

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 vial contains 10 ml equivalent to 1,000 IU. 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 vial of 10 ml

5 vials of 10 ml

Multipack: 5 packs of 1x10ml vial and not for sale as individual vials

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

During use: Store below 25°C. Do not refrigerate or freeze

Keep the vial in the outer carton 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

Discard the needle and syringe 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/1/02/229/003

 

 

 

 

 

 

1 vial of 10 ml

EU/1/02/229/004

5 vials of 10 ml

 

 

 

 

EU/1/02/229/037

Multipack: 5 packs of 1

x

ml vial and not for sale as individual vials

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 100

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 (VIAL)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Actraphane 30 100 IU/ml

Suspension for injection

Insulin human

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP/

4. BATCH NUMBER

Batch:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6. OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER WRAPPER LABEL ON MULTIPACKS (VIAL)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 40 IU/ml

Suspension for injection

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 vial contains 10 ml equivalent to 400 IU. 1 ml suspension contains 40 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 1.4 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 x 10 ml vial. Multipack: 5 packs of 1 x 10 ml vial and not for sale as individual vials

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

During use: Store below 25°C. Do not refrigerate or freeze

Keep the vial in the outer carton 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

Discard the needle and syringe 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/1/02/229/036

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 40

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 (VIAL)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 100 IU/ml

Suspension for injection

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 vial contains 10 ml equivalent to 1,000 IU. 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 x 10 ml vial. Multipack: 5 packs of 1 x 10 ml vial and not for sale as individual vials

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

During use: Store below 25°C. Do not refrigerate or freeze

Keep the vial in the outer carton 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

Discard the needle and syringe 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/1/02/229/037

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 100

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 CARTON (CARTRIDGE. Penfill)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 Penfill 100 IU/ml

Suspension for injection in cartridge

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 cartridge contains 3 ml equivalent to 300 IU. 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 x 3 ml cartridge

5 x 3 ml cartridges

10 x 3 ml cartridges

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

For use by one person only

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

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

Keep the cartridge in the outer carton 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

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/1/02/229/011 1 cartridge of 3 ml

EU/1/02/229/012 5 cartridges of 3 ml

EU/1/02/229/013 10 cartridges of 3 ml

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 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

Actraphane 30 Penfill 100 IU/ml

Suspension for injection

Insulin human

SC

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (PRE-FILLED PEN. InnoLet)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 InnoLet 100 IU/ml

Suspension for injection in pre-filled pen

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 pre-filled pen contains 3 ml equivalent to 300 IU. 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

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

Subcutaneous use

Read the package leaflet before use

Needles are not included

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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy 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 or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

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

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

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/1/02/229/030 1 pen of 3 ml

EU/1/02/229/031 5 pens of 3 ml

EU/1/02/229/032 10 pens of 3 ml

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 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

Actraphane 30 InnoLet 100 IU/ml

Suspension for injection

Insulin human

SC

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (PRE-FILLED PEN. FlexPen)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 30 FlexPen 100 IU/ml

Suspension for injection in pre-filled pen

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 pre-filled pen contains 3 ml equivalent to 300 IU. 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

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

Subcutaneous use

Read the package leaflet before use

Needles are not included

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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy 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 or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

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

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

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/1/02/229/033 1 pen of 3 ml

EU/1/02/229/034 5 pens of 3 ml

EU/1/02/229/035 10 pens of 3 ml

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 30 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

Actraphane 30 FlexPen 100 IU/ml

Suspension for injection

Insulin human

SC

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (CARTRIDGE. Penfill)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 40 Penfill 100 IU/ml

Suspension for injection in cartridge

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 cartridge contains 3 ml equivalent to 300 IU. 1 ml suspension contains 100 IU insulin human (40% as soluble insulin and 60% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 x 3 ml cartridge

5 x 3 ml cartridges

10 x 3 ml cartridges

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

For use by one person only

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

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

Keep the cartridge in the outer carton 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

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/1/02/229/014 1 cartridge of 3 ml

EU/1/02/229/015 5 cartridges of 3 ml

EU/1/02/229/016 10 cartridges of 3 ml

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 40 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

Actraphane 40 Penfill 100 IU/ml

Suspension for injection

Insulin human

SC

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (CARTRIDGE. Penfill)

1. NAME OF THE MEDICINAL PRODUCT

Actraphane 50 Penfill 100 IU/ml

Suspension for injection in cartridge

Insulin human

2. STATEMENT OF ACTIVE SUBSTANCE

1 cartridge contains 3 ml equivalent to 300 IU. 1 ml suspension contains 100 IU insulin human (50% as soluble insulin and 50% as isophane insulin) (equivalent to 3.5 mg),

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 x 3 ml cartridge

5 x 3 ml cartridges

10 x 3 ml cartridges

5. METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use

Read the package leaflet before 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

Resuspend according to instructions

Only use the resuspension if uniformly white and cloudy

For use by one person only

8. EXPIRY DATE

EXP/

During use or when carried as a spare: Use within 6 weeks

9. SPECIAL STORAGE CONDITIONS

Before opening: Store in a refrigerator. Do not freeze

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

Keep the cartridge in the outer carton 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

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/1/02/229/017 1 cartridge of 3 ml

EU/1/02/229/018 5 cartridges of 3 ml

EU/1/02/229/019 10 cartridges of 3 ml

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actraphane 50 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

Actraphane 50 Penfill 100 IU/ml

Suspension for injection

Insulin human

SC

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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