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Biopoin (epoetin theta) – Labelling - B03XA01

Updated on site: 05-Oct-2017

Medication nameBiopoin
ATC CodeB03XA01
Substanceepoetin theta
ManufacturerTeva GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

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

Epoetin theta

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 micrograms) epoetin theta per ml.

3.LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

6pre-filled syringes containing 0.5 ml.

6pre-filled syringes with safety needle containing 0.5 ml.

6pre-filled syringes with safety device containing 0.5 ml.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8.EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/001 6 pre-filled syringes

EU/1/09/565/002 6 pre-filled syringes with safety device

EU/1/09/565/029 6 pre-filled syringes with safety needle

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Biopoin 1,000 IU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

6pre-filled syringes containing 0.5 ml.

6pre-filled syringes with safety needle containing 0.5 ml.

6pre-filled syringes with safety device containing 0.5 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/003 6 pre-filled syringes

EU/1/09/565/004 6 pre-filled syringes with safety device

EU/1/09/565/030 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 2,000 IU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

6pre-filled syringes containing 0.5 ml.

6pre-filled syringes with safety needle containing 0.5 ml.

6pre-filled syringes with safety device containing 0.5 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/005 6 pre-filled syringes

EU/1/09/565/006 6 pre-filled syringes with safety device

EU/1/09/565/031 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 3,000 IU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

6pre-filled syringes containing 0.5 ml.

6pre-filled syringes with safety needle containing 0.5 ml.

6pre-filled syringes with safety device containing 0.5 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed dose

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/007 6 pre-filled syringes

EU/1/09/565/008 6 pre-filled syringes with safety device

EU/1/09/565/032 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 4,000 IU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

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

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

6pre-filled syringes containing 0.5 ml.

6pre-filled syringes with safety needle containing 0.5 ml.

6pre-filled syringes with safety device containing 0.5 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/009 6 pre-filled syringes

EU/1/09/565/010 6 pre-filled syringes with safety device

EU/1/09/565/033 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 5,000 IU/0.5 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

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

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1pre-filled syringe containing 1 ml.

1pre-filled syringe with safety needle containing 1 ml.

1pre-filled syringe with safety device containing 1 ml. 4 pre-filled syringes containing 1 ml.

4 pre-filled syringes with safety needle containing 1 ml. 4 pre-filled syringes with safety device containing 1 ml. 6 pre-filled syringes containing 1 ml.

6 pre-filled syringes with safety needle containing 1 ml. 6 pre-filled syringes with safety device containing 1 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/011 1 pre-filled syringe

EU/1/09/565/012 1 pre-filled syringe with safety device

EU/1/09/565/013 4 pre-filled syringes

EU/1/09/565/014 4 pre-filled syringes with safety device

EU/1/09/565/015 6 pre-filled syringes

EU/1/09/565/016 6 pre-filled syringes with safety device

EU/1/09/565/034 1 pre-filled syringe with safety needle

EU/1/09/565/035 4 pre-filled syringes with safety needle

EU/1/09/565/036 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 10,000 IU/1 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1pre-filled syringe containing 1 ml.

1pre-filled syringe with safety needle containing 1 ml.

1pre-filled syringe with safety device containing 1 ml. 4 pre-filled syringes containing 1 ml.

4 pre-filled syringes with safety needle containing 1 ml. 4 pre-filled syringes with safety device containing 1 ml. 6 pre-filled syringes containing 1 ml.

6 pre-filled syringes with safety needle containing 1 ml. 6 pre-filled syringes with safety device containing 1 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/017 1 pre-filled syringe

EU/1/09/565/018 1 pre-filled syringe with safety device

EU/1/09/565/019 4 pre-filled syringes

EU/1/09/565/020 4 pre-filled syringes with safety device

EU/1/09/565/021 6 pre-filled syringes

EU/1/09/565/022 6 pre-filled syringes with safety device

EU/1/09/565/037 1 pre-filled syringe with safety needle

EU/1/09/565/038 4 pre-filled syringes with safety needle

EU/1/09/565/039 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 20,000 IU/1 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe

Epoetin theta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml.

3. LIST OF EXCIPIENTS

Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment), water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1pre-filled syringe containing 1 ml.

1pre-filled syringe with safety needle containing 1 ml.

1pre-filled syringe with safety device containing 1 ml. 4 pre-filled syringes containing 1 ml.

4 pre-filled syringes with safety needle containing 1 ml. 4 pre-filled syringes with safety device containing 1 ml. 6 pre-filled syringes containing 1 ml.

6 pre-filled syringes with safety needle containing 1 ml. 6 pre-filled syringes with safety device containing 1 ml.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only.

Please use as follows:

Box for the prescribed posology

Subcutaneous or 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(S), IF NECESSARY

8. EXPIRY DATE

EXP

Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. End of 7 days period at room temperature: __/__/____

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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

TEVA GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/565/023 1 pre-filled syringe

EU/1/09/565/024 1 pre-filled syringe with safety device

EU/1/09/565/025 4 pre-filled syringes

EU/1/09/565/026 4 pre-filled syringes with safety device

EU/1/09/565/027 6 pre-filled syringes

EU/1/09/565/028 6 pre-filled syringes with safety device

EU/1/09/565/040 1 pre-filled syringe with safety needle

EU/1/09/565/041 4 pre-filled syringes with safety needle

EU/1/09/565/042 6 pre-filled syringes with safety needle

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Biopoin 30,000 IU/1 ml

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 1,000 IU/0.5 ml injection

Epoetin theta

SC IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6.OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 2,000 IU/0.5 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 3,000 IU/0.5 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 4,000 IU/0.5 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 5,000 IU/0.5 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 10,000 IU/1 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 20,000 IU/1 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

IU

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE

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

Biopoin 30,000 IU/1 ml injection

Epoetin theta

SC IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

IU

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