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Retacrit (epoetin zeta) – Labelling - B03XA01

Updated on site: 09-Oct-2017

Medication nameRetacrit
ATC CodeB03XA01
Substanceepoetin zeta
ManufacturerHospira UK Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe

Epoetin zeta

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 1 000 IU Epoetin zeta

3.LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.3 ml solution for injection 6 pre-filled syringes without needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle guard containing 0.3 ml solution for injection

6 pre-filled syringes with needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.3 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.3 ml solution for injection

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/001

EU/1/07/431/002

EU/1/07/431/026

EU/1/07/431/027

EU/1/07/431/054

EU/1/07/431/055

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Retacrit 1 000 IU

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

SYRINGE LABELS

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

Retacrit 1 000 IU Injection Epoetin zeta

iv/sc use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 000 IU/0.3 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 2 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection

6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/003

EU/1/07/431/004

EU/1/07/431/028

EU/1/07/431/029

EU/1/07/431/056

EU/1/07/431/057

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 2 000 IU

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

SYRINGE LABELS

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

Retacrit 2 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 000 IU/0.6 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 3 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.9 ml solution for injection 6 pre-filled syringes without needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle guard containing 0.9 ml solution for injection

6 pre-filled syringes with needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.9 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.9 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/005

EU/1/07/431/006

EU/1/07/431/030

EU/1/07/431/031

EU/1/07/431/058

EU/1/07/431/059

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 3 000 IU

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

SYRINGE LABELS

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

Retacrit 3 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 000 IU/0.9 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 4 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.4 ml solution for injection 6 pre-filled syringes without needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle guard containing 0.4 ml solution for injection

6 pre-filled syringes with needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.4 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.4 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/007

EU/1/07/431/008

EU/1/07/431/032

EU/1/07/431/033

EU/1/07/431/060

EU/1/07/431/061

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 4 000 IU

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

SYRINGE LABELS

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

Retacrit 4 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

4 000 IU/0.4 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 5 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.5 ml solution for injection 6 pre-filled syringes without needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle guard containing 0.5 ml solution for injection

6 pre-filled syringes with needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.5 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.5 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/009

EU/1/07/431/010

EU/1/07/431/034

EU/1/07/431/035

EU/1/07/431/062

EU/1/07/431/063

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 5 000 IU

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

SYRINGE LABELS

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

Retacrit 5 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 000 IU/0.5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 6 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection

6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/011

EU/1/07/431/012

EU/1/07/431/036

EU/1/07/431/037

EU/1/07/431/064

EU/1/07/431/065

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 6 000 IU

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

SYRINGE LABELS

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

Retacrit 6 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6 000 IU/0.6 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 8 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.8 ml solution for injection 6 pre-filled syringes without needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle guard containing 0.8 ml solution for injection

6 pre-filled syringes with needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.8 ml solution for injection

6 pre-filled syringes with needle-trap containing 0.8 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/013

EU/1/07/431/014

EU/1/07/431/038

EU/1/07/431/039

EU/1/07/431/066

EU/1/07/431/067

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 8 000 IU

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

SYRINGE LABELS

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

Retacrit 8 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

8 000 IU/0.8 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 10 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection

6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection

6 pre-filled syringes with needle-trap containing 1 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/015

EU/1/07/431/016

EU/1/07/431/040

EU/1/07/431/041

EU/1/07/431/068

EU/1/07/431/069

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 10 000 IU

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

SYRINGE LABELS

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

Retacrit 10 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 000 IU/1 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 20 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.5 ml solution for injection 4 pre-filled syringes without needle guard containing 0.5 ml solution for injection 6 pre-filled syringes without needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle guard containing 0.5 ml solution for injection

4 pre-filled syringes with needle guard containing 0.5 ml solution for injection 6 pre-filled syringes with needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.5 ml solution for injection

4 pre-filled syringes with needle-trap containing 0.5 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.5 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/017

EU/1/07/431/020

EU/1/07/431/021

EU/1/07/431/042

EU/1/07/431/045

EU/1/07/431/046

EU/1/07/431/070

EU/1/07/431/071

EU/1/07/431/072

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 20 000 IU

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

INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 20 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.5 ml solution for injection Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/051

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 20 000 IU

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 LABEL (WITH BLUE BOX) MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 20 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 6 (6 x 1) pre-filled syringes.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/051

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 20 000 IU

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

SYRINGE LABELS

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

Retacrit 20 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

20 000 IU/0.5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 30 000 IU/0.75ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 30 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.75 ml solution for injection 4 pre-filled syringes without needle guard containing 0.75 ml solution for injection 6 pre-filled syringes without needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle guard containing 0.75 ml solution for injection

4 pre-filled syringes with needle guard containing 0.75 ml solution for injection 6 pre-filled syringes with needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.75 ml solution for injection

4 pre-filled syringes with needle-trap containing 0.75 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.75 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/018

EU/1/07/431/022

EU/1/07/431/023

EU/1/07/431/043

EU/1/07/431/047

EU/1/07/431/048

EU/1/07/431/073

EU/1/07/431/074

EU/1/07/431/075

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 30 000 IU

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

INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 30 000 IU/0.75ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 30 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 0.75 ml solution for injection Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/052

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 30 000 IU

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 LABEL (WITH BLUE BOX) MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 30 000 IU/0.75ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 30 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 4 (4 x 1) pre-filled syringes.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/052

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 30 000 IU

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

SYRINGE LABELS

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

Retacrit 30 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 000 IU/0.75 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 40 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 1 ml solution for injection 4 pre-filled syringes without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre filled syringe with needle guard containing 1 ml solution for injection

4 pre-filled syringes with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre filled syringe with needle-trap containing 1 ml solution for injection

4 pre-filled syringes with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/019

EU/1/07/431/024

EU/1/07/431/025

EU/1/07/431/044

EU/1/07/431/049

EU/1/07/431/050

EU/1/07/431/076

EU/1/07/431/077

EU/1/07/431/078

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 40 000 IU

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

INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 40 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 pre-filled syringe without needle guard containing 1 ml solution for injection Component of a multipack, not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/053

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 40 000 IU

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 LABEL (WITH BLUE BOX) MULTIPACK

1. NAME OF THE MEDICINAL PRODUCT

Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe

Epoetin zeta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe contains 40 000 IU Epoetin zeta

3. LIST OF EXCIPIENTS

Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).

Contains phenylalanine, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 4 (4 x 1) pre-filled syringes.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous or subcutaneous use.

Read the package leaflet before use.

Do not shake.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe 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

Hospira UK Limited

Hurley

SL6 6RJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/431/053

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Retacrit 40 000 IU

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

SYRINGE LABELS

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

Retacrit 40 000 IU Injection Epoetin zeta

iv/sc use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

40 000 IU/1 ml

6. OTHER

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