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NovoEight (turoctocog alfa) – Labelling - B02BD02

Updated on site: 08-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1.NAME OF THE MEDICINAL PRODUCT

NovoEight 250 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2.STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 62.5 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3.LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5.METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12.MARKETING AUTHORISATION NUMBERS

EU/1/13/888/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

NovoEight 250 IU

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 250 IU powder for solution for injection

turoctocog alfa

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU

6.OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

NovoEight 500 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2. STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3. LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5. METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/13/888/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NovoEight 500 IU

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 500 IU powder for solution for injection

turoctocog alfa

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 IU

6. OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

NovoEight 1000 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2. STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 250 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3. LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5. METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/13/888/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NovoEight 1000 IU

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 1000 IU powder for solution for injection

turoctocog alfa

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1000 IU

6. OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

NovoEight 1500 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2. STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3. LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5. METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/13/888/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NovoEight 1500 IU

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 1500 IU powder for solution for injection

turoctocog alfa

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1500 IU

6. OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

NovoEight 2000 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2. STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 500 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3. LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5. METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/13/888/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NovoEight 2000 IU

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 2000 IU powder for solution for injection

turoctocog alfa

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2000 IU

6. OTHER

Novo Nordisk A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

NovoEight 3000 IU powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

2. STATEMENT OF ACTIVE SUBSTANCE

One ml of NovoEight contains approximately 750 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution

3. LIST OF EXCIPIENTS

Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid

Solvent: Sodium chloride

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in prefilled syringe, plunger rod and vial adapter

5. METHOD AND ROUTE OF ADMINISTRATION

Intravenous 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze

Can be stored at room temperature ≤ 30°C for a single period up to 9 months Taken out of refrigerator: _____________

Store in the original package in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

12. MARKETING AUTHORISATION NUMBERS

EU/1/13/888/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

NovoEight 3000 IU

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NovoEight 3000 IU powder for solution for injection

turoctocog alfa

Intravenous use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3000 IU

6. OTHER

Novo Nordisk A/S

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Prefilled syringe

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Solvent for NovoEight

Sodium chloride 9 mg/ml

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

4 ml

6. OTHER

Novo Nordisk A/S

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