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Betaferon (interferon beta-1b) – Labelling - L03AB08

Updated on site: 05-Oct-2017

Medication nameBetaferon
ATC CodeL03AB08
Substanceinterferon beta-1b
ManufacturerBayer AG  

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (15 VIALs / 15 PRE-FILLED SYRINGES)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

15 vials with powder and 15 pre-filled syringes with solvent:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains: sodium chloride solution 5.4 mg/ml.

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

(CARTON OF MULTIPACK (15x 1 SINGLE PACKS) (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack comprising 15 single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

(CARTON OF MULTIPACK (14x 1 SINGLE PACKS) (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack comprising 14 single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/009

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

(CARTON OF MULTIPACK (12x 1 SINGLE PACKS) (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack comprising 12 single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/011

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (5 VIALs / 5 PRE-FILLED SYRINGES (1.2 ml))

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4. PHARMACEUTICAL FORM AND CONTENTS

5 vials with powder and 5 pre-filled syringes with solvent

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains: sodium chloride solution 5.4 mg/ml.

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF MULTIPACKS (5x1 SINGLE PACK) (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack comprising 5 single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with solvent for reconstitution contains 1.2 ml sodium chloride solution 5.4 mg/ml.

III.1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/006

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 45 (3x 15) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

3-month pack comprising 45 (3x15) single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/007

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 42 (3x 14) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

3-month pack comprising 42 (3x14) single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/010

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 28 (2x 14) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

2-month pack comprising 28 (2x14) single packs, each containing:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/012

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAKING

CARTON WITH 15 SINGLE PACKS, PART OF A CARTON WITH 45 (3 x 15) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs. No individual sale of single packs.

Each single pack contains:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/007

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAKING

CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 42 (3 x 14) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Pack comprising 14 single packs, part of a 3-month pack containing 42 (3 x 14) single packs. No individual sale of single packs.

Each single pack contains:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/010

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAKING

CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 28 (2 x 14) SINGLE PACKS (INCLUDING BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Pack comprising 14 single packs, part of a 2-month pack containing 28 (2 x 14) single packs. No individual sale of single packs.

Each single pack contains:

I. 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.

III. 1 vial adapter with needle + 2 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/012

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS) , PART OF A CARTON WITH 15 SINGLE PACKS IN A CARTON OF 3x15 SINGLE PACKS

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs. No individual sale of single packs.

1 vial with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/007

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS) , PART OF A CARTON WITH 14 SINGLE PACKS IN A CARTON OF 3x14 SINGLE PACKS

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a pack containing 14 single packs in a 3-month pack of 3x14 single packs. No individual sale of single packs.

1 vial with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/010

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS), PART OF A CARTON WITH 14 SINGLE PACKS IN A CARTON OF 2x14 SINGLE PACKS

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a pack containing 14 single packs in a 2-month pack of 2x14 single packs. No individual sale of single packs.

1 vial with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/012

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

(TITRATION PACK WITH 4x1 TRIPLE PACK (3 VIALS/3 PRE-FILLED SYRINGES)), FOR FIRST 12 INJECTIONS/TREATMENT DAYS

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Titration pack

comprising 4 triple packs, each containing:

I. 3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU). After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.

II. 3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ml.

III.3 Vial adapters with needles + 6 alcohol wipes

*Betaferon is formulated to contain a calculated overfill of 20 %.

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with 1.2 ml of solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

Use yellow triple pack No. 1 for treatment days 1, 3 and 5

Use red triple pack No. 2 for treatment days 7, 9 and 11

Use green triple pack No. 3 for treatment days 13, 15 and 17

Use blue triple pack No. 4 for treatment days 19, 21 and 23

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 15 PACKS (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a multipack containing 15 single packs. No individual sale of single packs.

1 vial with powder: 300 mcg (9.6 m IU) per vial. When reconstituted 250 mcg/ml (8.0 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 14 PACKS (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a multipack containing 14 single packs. No individual sale of single packs.

1 vial with powder: 300 mcg (9.6 m IU) per vial. When reconstituted 250 mcg/ml (8 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/009

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1VIAL/1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 12 PACKS (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a multipack containing 12 single packs. No individual sale of single packs.

1 vial with powder: 300 mcg (9.6 m IU) per vial. When reconstituted 250 mcg/ml (8.0 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate useis recommended. In-use stability demonstrated for 3 hours at 2- 8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/011

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 SINGLE PACK (1 VIAL/1 PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 5 PACKS (WITHOUT BLUE BOX)

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b per ml when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Part of a multipack containing 5 single packs. No individual sale of single packs.

1 vial with powder: 300 mcg (9.6 m IU) per vial. When reconstituted 250 mcg/ml (8.0 m IU/ml) interferon beta-1b.

1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2- 8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/006

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS –TREATMENT DAYS 1, 3, 5

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Triple pack 1

1st dosage step (0.25 ml) for treatment days 1, 3, 5

Part of a titration pack. No individual sale.

3 Vials with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 Vial adapters with needles + 6 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-

8°C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE (text for inside the lid)

Dear patient,

Triple pack 1 is designed to help you prepare the first 3 injections (days 1, 3 and 5). Use all the solvent in the syringe to dissolve the Betaferon powder in the vial. Then draw up solution as far as the mark on the syringe:

0.25 ml

for first three injections (at day 1, 3 and 5 of therapy).

Discard the vial with the remaining solution.

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS –TREATMENT DAYS 7, 9, 11

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Triple pack 2

2nd dosage step (0.5 ml) for treatment days 7, 9, 11

Part of a titration pack. No individual sale.

3 vials with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

3 pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 vial adapters with needles + 6 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE (text for inside the lid)

Dear patient,

Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11). Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.

Then draw up solution as far as the mark on the syringe: 0.5 ml for the injections at day 7, 9 and 11 of therapy.

Discard the vial with the remaining solution.

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS –TREATMENT DAYS 13, 15, 17

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Triple pack 3

3rd dosage step (0.75 ml) for treatment days 13, 15, 17

Part of a titration pack. No individual sale.

3 vials with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

3 pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 vial adapters with needles + 6 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE (text for inside the lid)

Dear patient,

Triple pack 3 is designed to help you prepare the next 3 injections (days 13, 15 and 17). Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.

Then draw up solution as far as the mark on the syringe: 0.75 ml for the injections at day 13, 15 and 17 of therapy.

Discard the vial with the remaining solution.

16.INFORMATION IN BRAILLE

Betaferon

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 1 TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS –TREATMENT DAYS 19, 21, 23

1.NAME OF THE MEDICINAL PRODUCT

Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.

3.LIST OF EXCIPIENTS

Excipients: Human albumin, mannitol

4.PHARMACEUTICAL FORM AND CONTENTS

Triple pack 4

4th dosage step (1.0 ml) for treatment days 19, 21, 23

Part of a titration pack. No individual sale.

3 Vials with powder: 300 microgram (9.6 m IU) per vial. When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.

3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 Vial adapters with needles + 6 alcohol wipes

5.METHOD AND ROUTE OF ADMINISTRATION

For subcutaneous injection after reconstitution with solvent.

Single use.

Read the package leaflet before 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

After reconstitution, immediate use is recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Do not freeze.

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

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER

EU/1/95/003/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE (text for inside the lid)

Dear patient,

Triple pack 4 is designed to help you prepare the next 3 injections (days 19, 21 and 23). Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.

Then draw up solution as far as the 1.0 ml mark on the syringe: 1.0 ml for the injections at day 19, 21 and 23 of therapy.

Discard the vial with the remaining solution.

16.INFORMATION IN BRAILLE

Betaferon

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (SOLVENT / BLISTER OF PRE-FILLED SYRINGE)

1.NAME OF THE MEDICINAL PRODUCT

Solvent for reconstitution of Betaferon 1.2 ml sodium chloride solution 5.4 mg/ml

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Bayer AG

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.OTHER

Read the package leaflet before use.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (SOLVENT / PREFILLED SYRINGE)

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Solvent for reconstitution of Betaferon 1.2 ml sodium chloride solution 5.4 mg/ml

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1.2 ml

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIALs BETAFERON (VIALs / PFS))

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Betaferon 250 microgram/ml, powder for solution for injection interferon beta-1b Subcutaneous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

After reconst. immediate use recommended. In-use stability demonstrated for 3 hours at 2-8 °C.

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 mcg (8 m IU) per ml after reconstitution

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