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Refixia (nonacog beta pegol) – Labelling - B02BD04

Updated on site: 09-Oct-2017

Medication nameRefixia
ATC CodeB02BD04
Substancenonacog beta pegol
ManufacturerNovo Nordisk A/S

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1.NAME OF THE MEDICINAL PRODUCT

Refixia 500 IU powder and solvent for solution for injection

nonacog beta pegol

(recombinant coagulation factor IX)

2.STATEMENT OF ACTIVE SUBSTANCE

Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),

3.LIST OF EXCIPIENTS

Powder:

sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter

5.METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, after reconstitution

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 (up to 30°C) for a single period up to 6 months. Must not be returned to refrigerator after storage at room temperature

Date removed from refrigerator: ____________

Store in the original package 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 NUMBER

EU/1/17/1193/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Refixia 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

Refixia 500 IU powder for solution for injection

nonacog beta pegol

IV

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

Refixia 1000 IU powder and solvent for solution for injection

nonacog beta pegol

(recombinant coagulation factor IX)

2.STATEMENT OF ACTIVE SUBSTANCE

Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),

3.LIST OF EXCIPIENTS

Powder:

sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter

5.METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, after reconstitution

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 (up to 30°C) for a single period up to 6 months. Must not be returned to refrigerator after storage at room temperature

Date removed from refrigerator: ____________

Store in the original package 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 NUMBER

EU/1/17/1193/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Refixia 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

Refixia 1000 IU powder for solution for injection

nonacog beta pegol

IV

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

Refixia 2000 IU powder and solvent for solution for injection

nonacog beta pegol

(recombinant coagulation factor IX)

2.STATEMENT OF ACTIVE SUBSTANCE

Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),

3.LIST OF EXCIPIENTS

Powder:

sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter

5.METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use

Intravenous use, after reconstitution

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 (up to 30°C) for a single period up to 6 months. Must not be returned to refrigerator after storage at room temperature

Date removed from refrigerator: ____________

Store in the original package 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 NUMBER

EU/1/17/1193/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Refixia 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

Refixia 2000 IU powder for solution for injection

nonacog beta pegol

IV

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pre-filled syringe

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Solvent for Refixia

Histidine solution

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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