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Bemfola (follitropin alfa) – Labelling - G03GA05

Updated on site: 05-Oct-2017

Medication nameBemfola
ATC CodeG03GA05
Substancefollitropin alfa
ManufacturerGedeon Richter Plc.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 5 OR 10 PRE-FILLED PENS

1.NAME OF THE MEDICINAL PRODUCT

Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen delivers 75 IU follitropin alfa, equivalent to 5.5 micrograms per 0.125 mL. Each mL of the solution contains 600 IU equivalent to 44 micrograms.

3.LIST OF EXCIPIENTS

Poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen 1 pre-filled pen

1 injection needle

5 pre-filled pens

5 injection needles

10 pre-filled pens

10 injection needles

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

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

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

Within its shelf-life, the medicine may be stored at or below 25°C for up to 3 months without being refrigerated and must be discarded if it has not been used after 3 months.

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

Gedeon Richter Plc.

Gyömrői út 19-21. 1103 Budapest Hungary

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/909/001

EU/1/13/909/006

EU/1/13/909/007

13.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

bemfola 75 iu/0.125 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

PRE-FILLED PEN LABEL

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

Bemfola 75 IU/0.125 mL injection follitropin alfa

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.125 mL

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 5 OR 10 PRE-FILLED PENS

1. NAME OF THE MEDICINAL PRODUCT

Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen follitropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL. Each mL of the solution contains 600 IU equivalent to 44 micrograms.

3. LIST OF EXCIPIENTS

Poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen 1 pre-filled pen

1 injection needle

5 pre-filled pens

5 injection needles

10 pre-filled pens

10 injection needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

Within its shelf-life, the medicine may be stored at or below 25°C for up to 3 months without being refrigerated and must be discarded if it has not been used after 3 months.

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

Gedeon Richter Plc.

Gyömrői út 19-21. 1103 Budapest Hungary

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/909/002

EU/1/13/909/008

EU/1/13/909/009

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Bemfola 150 IU/0.25 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

PRE-FILLED PEN LABEL

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

Bemfola 150 IU/0.25 mL injection follitropin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.25 mL

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 5 OR 10 PRE-FILLED PENS

1. NAME OF THE MEDICINAL PRODUCT

Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen follitropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL. Each mL of the solution contains 600 IU equivalent to 44 micrograms.

3. LIST OF EXCIPIENTS

Poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen 1 pre-filled pen

1 injection needle

5 pre-filled pens

5 injection needles

10 pre-filled pens

10 injection needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

Within its shelf-life, the medicine may be stored at or below 25°C for up to 3 months without being refrigerated and must be discarded if it has not been used after 3 months.

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

Gedeon Richter Plc.

Gyömrői út 19-21. 1103 Budapest Hungary

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/909/003

EU/1/13/909/010

EU/1/13/909/011

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Bemfola 225 IU/0.375 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

PRE-FILLED PEN LABEL

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

Bemfola 225 IU/0.375 mL injection follitropin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.375 mL

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 5 OR 10 PRE-FILLED PENS

1. NAME OF THE MEDICINAL PRODUCT

Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen follitropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL. Each mL of the solution contains 600 IU equivalent to 44 micrograms.

3. LIST OF EXCIPIENTS

Poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen 1 pre-filled pen

1 injection needle

5 pre-filled pens

5 injection needles

10 pre-filled pens

10 injection needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

Within its shelf-life, the medicine may be stored at or below 25°C for up to 3 months without being refrigerated and must be discarded if it has not been used after 3 months.

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

Gedeon Richter Plc.

Gyömrői út 19-21. 1103 Budapest Hungary

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/909/004

EU/1/13/909/012

EU/1/13/909/013

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Bemfola 300 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

PRE-FILLED PEN LABEL

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

Bemfola 300 IU/0.50 mL injection follitropin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 mL

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 5 OR 10 PRE-FILLED PENS

1. NAME OF THE MEDICINAL PRODUCT

Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL. Each mL of the solution contains 600 IU equivalent to 44 micrograms.

3. LIST OF EXCIPIENTS

Poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection in pre-filled pen 1 pre-filled pen

1 injection needle

5 pre-filled pens

5 injection needles

10 pre-filled pens

10 injection needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

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

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

Within its shelf-life, the medicine may be stored at or below 25°C for up to 3 months without being refrigerated and must be discarded if it has not been used after 3 months.

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

Gedeon Richter Plc.

Gyömrői út 19-21. 1103 Budapest Hungary

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/909/005

EU/1/13/909/014

EU/1/13/909/015

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Bemfola 450 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

PRE-FILLED PEN LABEL

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

Bemfola 450 IU/0.75 mL injection follitropin alfa

SC

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.75 mL

6. OTHER

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