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Advate (octocog alfa) – Labelling - B02BD02

Updated on site: 05-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT II DEVICE)

1.NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3.LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 250 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/001

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ADVATE 250

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 250 IU powder for solution for injection

Octocog alfa

IV use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU octocog alfa

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 250 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/011

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 250

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection Octocog alfa

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5.OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 250

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/002

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 500

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 500 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/012

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 500

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 500

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/003

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 1000 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1000 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/013

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1000

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 1000

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/004

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1500

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 1500 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1500 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/014

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1500

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 1500

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 2000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 2000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/005

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 2000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 2000 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2000 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 2000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 2000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/015

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 2000

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 2000

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 2000

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 3000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 3000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/006

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 3000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 3000 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3000 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 3000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/016

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 3000

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 5 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 3000

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 3000

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/007

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 250

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 250 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/017

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 250

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 2 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 250

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 250

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/008

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 500

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 500 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/018

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 500

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 2 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 500

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 500

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/009

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 1000 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1000 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/019

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1000

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 2 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1000

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 1000

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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 (BAXJECT II DEVICE)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/010

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1500

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)

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

ADVATE 1500 IU powder for solution for injection

Octocog alfa

IV use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use only.

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1500 IU octocog alfa

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)

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

Sterilised water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection

Octocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution. Specific activity: approx. 4,000 – 10,000 IU/mg protein

3. LIST OF EXCIPIENTS

Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, after reconstitution.

Single use only.

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

EXP:

End of 6 month period, if stored at room temperature:

Do not use after the expiry date.

Use immediately or within 3 hours of reconstitution.

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

Can be stored at room temperature (up to 25 °C) for a single period up to 6 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

Baxter AG

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/271/020

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADVATE 1500

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

Intravenous use, after reconstitution.

Use immediately or within 3 hours of reconstitution. Do not use if packaging is opened or damaged.

Powder vial and 2 ml solvent preassembled in BAXJECT III system.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)

1. NAME OF THE MEDICINAL PRODUCT

ADVATE 1500

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Baxter AG

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)

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

ADVATE 1500

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)

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

Sterilised water for injections

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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