English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Taltz (ixekizumab) – Labelling - L04

Updated on site: 10-Oct-2017

Medication nameTaltz
ATC CodeL04
Substanceixekizumab
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON - PRE-FILLED SYRINGE

1.NAME OF THE MEDICINAL PRODUCT

Taltz 80 mg solution for injection in pre-filled syringe ixekizumab

2.STATEMENT OF ACTIVE SUBTANCE(S)

Each pre-filled syringe contains 80 mg of ixekizumab in 1 ml solution.

3.LIST OF EXCIPIENTS

Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

1 pre-filled syringe of 1 ml solution

2 pre-filled syringes of 1 ml solution

3 pre-filled syringes of 1 ml solution

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

If seal is broken, do not use.

Do not shake.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package 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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1085/004 1 pre-filled syringe

EU/1/15/1085/005 2 pre-filled syringes

EU/1/15/1085/006 3 pre-filled syringes

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Taltz

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 - PRE-FILLED PEN

1. NAME OF THE MEDICINAL PRODUCT

Taltz 80 mg solution for injection in pre-filled pen ixekizumab

2. STATEMENT OF ACTIVE SUBTANCE(S)

Each pre-filled pen contains 80 mg of ixekizumab in 1 ml solution.

3. LIST OF EXCIPIENTS

Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection.

1 pre-filled pen of 1 ml solution

2 pre-filled pens of 1 ml solution

3 pre-filled pens of 1 ml solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Subcutaneous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

If seal is broken, do not use.

Do not shake.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package 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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1085/001 1 pre-filled pen

EU/1/15/1085/002 2 pre-filled pens

EU/1/15/1085/003 3 pre-filled pens

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Taltz

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

PRE-FILLED SYRINGE LABEL

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

Taltz 80 mg injection ixekizumab Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED PEN LABEL

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

Taltz 80 mg solution for injection ixekizumab

Subcutaneous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed