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Abseamed (epoetin alfa) – Labelling - B03XA01

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Abseamed 1,000 IU/0.5 ml solution for injection in a pre-filled syringe

Epoetin alfa

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.5 ml contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.

3.LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.5 ml 6 pre-filled syringes of 0.5 ml

1pre-filled syringe of 0.5 ml with a needle safety guard 6 pre-filled syringes of 0.5 ml with a needle safety guard

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/001

EU/1/07/412/002

EU/1/07/412/027

EU/1/07/412/028

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Abseamed 1,000 IU/0.5 ml

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/SYRINGE

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

Abseamed 1,000 IU/0.5 ml injection

Epoetin alfa

IV/SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 2,000 IU/1 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 1 ml contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml

1pre-filled syringe of 1 ml with a needle safety guard 6 pre-filled syringes of 1 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/003

EU/1/07/412/004

EU/1/07/412/029

EU/1/07/412/030

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 2,000 IU/1 ml

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/SYRINGE

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

Abseamed 2,000 IU/1 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 3,000 IU/0.3 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.3 ml contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.3 ml 6 pre-filled syringes of 0.3 ml

1pre-filled syringe of 0.3 ml with a needle safety guard 6 pre-filled syringes of 0.3 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/005

EU/1/07/412/006

EU/1/07/412/031

EU/1/07/412/032

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 3,000 IU/0.3 ml

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/SYRINGE

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

Abseamed 3,000 IU/0.3 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 4,000 IU/0.4 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.4 ml contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.4 ml 6 pre-filled syringes of 0.4 ml

1pre-filled syringe of 0.4 ml with a needle safety guard 6 pre-filled syringes of 0.4 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/007

EU/1/07/412/008

EU/1/07/412/033

EU/1/07/412/034

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 4,000 IU/0.4 ml

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/SYRINGE

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

Abseamed 4,000 IU/0.4 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 5,000 IU/0.5 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.5 ml contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.5 ml 6 pre-filled syringes of 0.5 ml

1pre-filled syringe of 0.5 ml with a needle safety guard 6 pre-filled syringes of 0.5 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/009

EU/1/07/412/010

EU/1/07/412/035

EU/1/07/412/036

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 5,000 IU/0.5 ml

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/SYRINGE

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

Abseamed 5,000 IU/0.5 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 6,000 IU/0.6 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.6 ml contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.6 ml 6 pre-filled syringes of 0.6 ml

1pre-filled syringe of 0.6 ml with a needle safety guard 6 pre-filled syringes of 0.6 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/011

EU/1/07/412/012

EU/1/07/412/037

EU/1/07/412/038

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 6,000 IU/0.6 ml

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/SYRINGE

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

Abseamed 6,000 IU/0.6 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 7,000 IU/0.7 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.7 ml contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.7 ml 6 pre-filled syringes of 0.7 ml

1pre-filled syringe of 0.7 ml with a needle safety guard 6 pre-filled syringes of 0.7 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/017

EU/1/07/412/018

EU/1/07/412/039

EU/1/07/412/040

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 7,000 IU/0.7 ml

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/SYRINGE

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

Abseamed 7,000 IU/0.7 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 8,000 IU/0.8 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.8 ml contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.8 ml 6 pre-filled syringes of 0.8 ml

1pre-filled syringe of 0.8 ml with a needle safety guard 6 pre-filled syringes of 0.8 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/013

EU/1/07/412/014

EU/1/07/412/041

EU/1/07/412/042

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 8,000 IU/0.8 ml

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/SYRINGE

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

Abseamed 8,000 IU/0.8 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 9,000 IU/0.9 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.9 ml contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.9 ml 6 pre-filled syringes of 0.9 ml

1pre-filled syringe of 0.9 ml with a needle safety guard 6 pre-filled syringes of 0.9 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/019

EU/1/07/412/020

EU/1/07/412/043

EU/1/07/412/044

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 9,000 IU/0.9 ml

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/SYRINGE

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

Abseamed 9,000 IU/0.9 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 10,000 IU/1 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 1 ml contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml

1pre-filled syringe of 1 ml with a needle safety guard 6 pre-filled syringes of 1 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/015

EU/1/07/412/016

EU/1/07/412/045

EU/1/07/412/046

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 10,000 IU/1 ml

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/SYRINGE

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

Abseamed 10,000 IU/1 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 20,000 IU/0.5 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.5 ml contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.5 ml 6 pre-filled syringes of 0.5 ml

1pre-filled syringe of 0.5 ml with a needle safety guard 4 pre-filled syringes of 0.5 ml with a needle safety guard 6 pre-filled syringes of 0.5 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/021

EU/1/07/412/022

EU/1/07/412/047

EU/1/07/412/053

EU/1/07/412/048

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 20,000 IU/0.5 ml

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/SYRINGE

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

Abseamed 20,000 IU/0.5 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 30,000 IU/0.75 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 0.75 ml contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 0.75 ml 6 pre-filled syringes of 0.75 ml

1pre-filled syringe of 0.75 ml with a needle safety guard 4 pre-filled syringes of 0.75 ml with a needle safety guard 6 pre-filled syringes of 0.75 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/023

EU/1/07/412/024

EU/1/07/412/049

EU/1/07/412/054

EU/1/07/412/050

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 30,000 IU/0.75 ml

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/SYRINGE

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

Abseamed 30,000 IU/0.75 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Abseamed 40,000 IU/1 ml solution for injection in a pre-filled syringe

Epoetin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 pre-filled syringe of 1 ml contains 40,000 international units (IU) corresponding to

336.0micrograms epoetin alfa.

3. LIST OF EXCIPIENTS

Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in a pre-filled syringe.

1pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml

1pre-filled syringe of 1 ml with a needle safety guard 4 pre-filled syringes of 1 ml with a needle safety guard 6 pre-filled syringes of 1 ml with a needle safety guard

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For subcutaneous and intravenous 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 and transport refrigerated (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

Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/412/025

EU/1/07/412/026

EU/1/07/412/051

EU/1/07/412/055

EU/1/07/412/052

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Abseamed 40,000 IU/1 ml

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/SYRINGE

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

Abseamed 40,000 IU/1 ml injection

Epoetin alfa

IV/SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

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