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Lantus (insulin glargine) – Labelling - A10AE04

Updated on site: 08-Oct-2017

Medication nameLantus
ATC CodeA10AE04
Substanceinsulin glargine
Manufacturersanofi-aventis Deutschland GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (5 ml vial)

1.NAME OF THE MEDICINAL PRODUCT

Lantus 100 units/ml solution for injection in a vial insulin glargine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 100 units (3.64 mg) insulin glargine.

3.LIST OF EXCIPIENTS

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

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial of 5 ml.

2 vials of 5 ml.

5 vials of 5 ml.

10 vials of 5 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

Use only clear and colourless solutions.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Unopened vials:

Store in a refrigerator.

Do not freeze or place next to the freezer or a freezer pack.

Once in use, vials may be stored for a maximum of 4 weeks not above 25°C.

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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Germany.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/134/001 1 vial of 5 ml

EU/1/00/134/002 2 vials of 5 ml

EU/1/00/134/003 5 vials of 5 ml

EU/1/00/134/004 10 vials of 5 ml

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Lantus

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 (5 ml vial)

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

Lantus 100 units/ml solution for injection insulin glargine

2.METHOD OF ADMINISTRATION

Subcutaneous use

3.EXPIRY DATE

EXP

Date of first use:……………

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (10 ml vial)

1. NAME OF THE MEDICINAL PRODUCT

Lantus 100 units/ml solution for injection in a vial insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 100 units (3.64 mg) insulin glargine.

3. LIST OF EXCIPIENTS

Excipients: zinc chloride, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), polysorbate 20, , water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 vial of 10 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

Use only clear and colourless solutions.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Unopened vials:

Store in a refrigerator.

Do not freeze or place next to the freezer or a freezer pack.

Once in use, vials may be stored for a maximum of 4 weeks not above 30°C. 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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Germany.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/134/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Lantus

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 (10 ml vial)

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

Lantus 100 units/ml solution for injection insulin glargine

2. METHOD OF ADMINISTRATION

Subcutaneous use

3. EXPIRY DATE

EXP

Date of first use:……………

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (cartridge)

1. NAME OF THE MEDICINAL PRODUCT

Lantus 100 units/ml solution for injection in a cartridge insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 100 units (3.64 mg) insulin glargine.

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 cartridge of 3 ml. 3 cartridges of 3 ml. 4 cartridges of 3 ml. 5 cartridges of 3 ml. 6 cartridges of 3 ml. 8 cartridges of 3 ml. 9 cartridges of 3 ml. 10 cartridges of 3 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

The Lantus cartridges are to be used only with the pens: OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, JuniorSTAR.

Not all of these pens may be marketed in your country.

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

Use only clear and colourless solutions.

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Unopened cartridges:

Store in a refrigerator.

Do not freeze or place next to the freezer or a freezer pack. Keep the cartridge in the outer carton in order to protect from light.

Once in use the cartridge may be stored for a maximum of 4 weeks not above 30°C. The pen containing the cartridge must not be stored in the refrigerator.

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Germany.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/134/013 1 cartridge of 3 ml

EU/1/00/134/014 3 cartridges of 3 ml

EU/1/00/134/005 4 cartridges of 3 ml

EU/1/00/134/006 5 cartridges of 3 ml

EU/1/00/134/015 6 cartridges of 3 ml

EU/1/00/134/016 8 cartridges of 3 ml

EU/1/00/134/017 9 cartridges of 3 ml

EU/1/00/134/007 10 cartridges of 3 ml

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Lantus

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)

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

Lantus 100 units/ml solution for injection insulin glargine

2. METHOD OF ADMINISTRATION

Subcutaneous use

Use specific pens: see leaflet.

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 BLISTERS OR STRIPS

TEXT TO APPEAR ON THE ALUMINIUM FOIL WHICH IS USED FOR SEALING TRANSPARENT PLASTIC TRAY CONTAINING THE CARTRIDGE

1. NAME OF THE MEDICINAL PRODUCT

2.NAME OF THE MARKETING AUTHORISATION HOLDER

3. EXPIRY DATE

4. BATCH NUMBER

5.OTHER

After inserting a new cartridge:

You must check that your insulin pen is working properly before you inject the first dose. Consult your insulin pen instruction booklet for further details.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (Pre-filled pen. SoloStar)

1. NAME OF THE MEDICINAL PRODUCT

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen insulin glargine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 100 units (3.64 mg) insulin glargine.

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 1 pen of 3 ml

3 pens of 3 ml

4 pens of 3 ml

5 pens of 3 ml

6 pens of 3 ml

8 pens of 3 ml

9 pens of 3 ml

10 pens of 3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use

Open here

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

Use only clear and colourless solutions.

Only use needles that are compatible for use with SoloStar.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Unopened:

Store in a refrigerator.

Do not freeze or place next to the freezer or a freezer pack.

Keep the pre-filled pen in the outer carton in order to protect from light.

In use conditions:

After its first use, the pen may be stored for a maximum of 4 weeks not above 30°C. Do not refrigerate. Keep the pen protected 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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Germany.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/134/030 1 pen of 3 ml.

EU/1/00/134/031 3 pens of 3 ml

EU/1/00/134/032 4 pens of 3 ml

EU/1/00/134/033 5 pens of 3 ml

EU/1/00/134/034 6 pens of 3 ml

EU/1/00/134/035 8 pens of 3 ml

EU/1/00/134/036 9 pens of 3 ml

EU/1/00/134/037 10 pens of 3 ml

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Lantus SoloStar

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.SoloStar)

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

Lantus SoloStar 100 units/ml solution for injection insulin glargine

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

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