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Humalog (insulin lispro) – Labelling - A10AC04

Updated on site: 07-Oct-2017

Medication nameHumalog
ATC CodeA10AC04
Substanceinsulin lispro
ManufacturerEli Lilly Nederland B.V.

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Vial. Pack of 1 and 2

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml solution for injection in vial

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7H20 with m-cresol as a preservative in water for injection.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial of 10ml

2 vials of 10 ml

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30°C.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/002

EU/1/96/007/020

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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 – Vial

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml solution for injection in vial

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7H20 with m-cresol as a preservative in water for injection.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

Multipack: 5 vials of 10ml. Component of a multipack, can’t be sold separately.

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30°C.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/021

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – Vial

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml solution for injection in vial

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7H20 with m-cresol as a preservative in water for injection.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

Multipack: 5 (5 packs of 1) vials of 10 ml.

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30°C.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/021

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION

Humalog 100 units/ml solution for injection in vial

Insulin lispro

Subcutaneous and intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON - Cartridges. Pack of 5 and 10

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml solution for injection in cartridge

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate7H20 with m-cresol as a preservative in water for injection.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

5 cartridges of 3ml

10 cartridges of 3ml

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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

These cartridges are for use with a 3 ml pen only.

If the 40 units/ml vial is the product normally prescribed, do not take insulin from a 100 units/ml cartridge using a 40 units/ml syringe.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/004

EU/1/96/007/023

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

(To open, lift here and pull) CARTON HAS BEEN OPENED

16.INFORMATION IN BRAILLE

Humalog

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION

Humalog 100 units/ml solution for injection in cartridge

Insulin lispro

Subcutaneous and intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Vial. Pack of 1

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix25 100 units/ml suspension for injection in vial 25% insulin lispro and 75% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate.7H2O with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 vial of 10ml

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

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30°C.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog Mix25 100 units/ml suspension for injection in vial 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Cartridges. Pack of 5 and 10

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix25 100 units/ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 5 cartridges of 3ml

10 cartridges of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

These cartridges are for use with a 3 ml pen only.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/008

EU/1/96/007/024

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

(To open, lift here and pull) CARTON HAS BEEN OPENED

16.INFORMATION IN BRAILLE

Humalog Mix25

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog Mix25 100 units/ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – Cartridges. Pack of 5 and 10

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix50 100 units/ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 5 cartridges of 3ml

10 cartridges of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

These cartridges are for use with a 3 ml pen only.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/006

EU/1/96/007/025

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

(To open, lift here and pull) CARTON HAS BEEN OPENED

16.INFORMATION IN BRAILLE

Humalog Mix50

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog Mix50 100 units/ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON - Cartridges. Pack of 5 and 10

1.NAME OF THE MEDICINAL PRODUCT

Humalog BASAL 100 units/ml suspension for injection in cartridge

Insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 5 cartridges of 3ml

10 cartridges of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

These cartridges are for use with a 3 ml pen only.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use cartridges may be used for up to 21 days. Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/010

EU/1/96/007/029

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

(To open, lift here and pull) CARTON HAS BEEN OPENED

16.INFORMATION IN BRAILLE

Humalog BASAL

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog BASAL 100 units/ml suspension for injection in cartridge

Insulin lispro protamine suspension

Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – KwikPen. Pack of 5

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml KwikPen, solution for injection

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen.

5 pens of 3ml

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/031

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog KwikPen

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

Humalog 100 units/ml KwikPen, solution for injection

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

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 ROUTES OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/032

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog KwikPen

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1.NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml KwikPen, solution for injection

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen.

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

5.METHOD AND ROUTES OF ADMINISTRATION

Read the package leaflet before use

Subcutaneous and intravenous 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, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/032

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog KwikPen

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION

Humalog 100 units/ml KwikPen, solution for injection

Insulin lispro

Subcutaneous and intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – KwikPen. Pack of 5

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix25 100 units/ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 5 pens of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/033

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog Mix25 KwikPen

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

Humalog Mix25 100 units/ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection KwikPen

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

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/034

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog Mix25 KwikPen

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix25 100 units/ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen.

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

5.METHOD AND ROUTES 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, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/034

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog Mix25 KwikPen

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog Mix25 100 units/ml KwikPen, suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – KwikPen. Pack of 5

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix50 100 units/ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen 5 pens of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/035

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog Mix50 KwikPen

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

Humalog Mix50 100 units/ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen.

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

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/036

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog Mix50 KwikPen

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1.NAME OF THE MEDICINAL PRODUCT

Humalog Mix50 100 units/ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen.

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

5.METHOD AND ROUTES 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, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/036

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog Mix50 KwikPen

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog Mix50 100 units/ml KwikPen, suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – KwikPen. Pack of 5

1.NAME OF THE MEDICINAL PRODUCT

Humalog BASAL 100 units/ml KwikPen, suspension for injection

Insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen 5 pens of 3ml

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 21 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/037

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog BASAL KwikPen

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

Humalog BASAL 100 units/ml KwikPen, suspension for injection

Insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen.

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

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 WARNING, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 21 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/038

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

If seal is broken before first use, contact pharmacist.

16.INFORMATION IN BRAILLE

Humalog BASAL KwikPen

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1.NAME OF THE MEDICINAL PRODUCT

Humalog BASAL 100 units/ml KwikPen, suspension for injection

Insulin lispro protamine suspension

2.STATEMENT OF ACTIVE SUBSTANCE

One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg).

3.LIST OF EXCIPIENTS

Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and phenol as preservatives in water for injections.

Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. KwikPen.

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

5.METHOD AND ROUTES 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, IF NECESSARY

Resuspend carefully. See enclosed package leaflet.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 21 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/038

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog Basal KwikPen

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Humalog BASAL 100 units/ml KwikPen, suspension for injection

Insulin lispro protamine suspension

Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml (3.5 mg/ml)

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

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

1.NAME OF THE MEDICINAL PRODUCT

Humalog 200 units/ml solution for injection in pre-filled pen

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg)

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

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 ROUTES 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, IF NECESSARY

Use only in this pen, or severe overdose can result.

If seal is broken before first use, contact pharmacist.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/039 1 pen

EU/1/96/007/040 2 pens

EU/1/96/007/041 5 pens

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog 200 units/ml

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

Humalog 200 units/ml solution for injection in pre-filled pen

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg)

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

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 ROUTES 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, IF NECESSARY

Use only in this pen, or severe overdose can result.

If seal is broken before first use, contact pharmacist.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/042

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog 200 units/ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (with blue box) multipack – KwikPen

1.NAME OF THE MEDICINAL PRODUCT

Humalog 200 units/ml solution for injection in pre-filled pen

Insulin lispro

2.STATEMENT OF ACTIVE SUBSTANCE

One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg)

3.LIST OF EXCIPIENTS

Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection. KwikPen.

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

5.METHOD AND ROUTES 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, IF NECESSARY

Use only in this pen, or severe overdose can result.

If seal is broken before first use, contact pharmacist.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30°C and should not be refrigerated.

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 Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER

EU/1/96/007/042

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Humalog 200 units/ml

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

LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION

Humalog 200 units/ml KwikPen, solution for injection

Insulin lispro

Subcutaneous 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

USE ONLY IN THIS PEN, OR SEVERE OVERDOSE CAN RESULT.

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