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Helixate NexGen (octocog alfa) – Labelling - B02BD02

Updated on site: 07-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Helixate NexGen 250 IU powder and solvent for solution for injection

Helixate NexGen 500 IU powder and solvent for solution for injection

Helixate NexGen 1000 IU powder and solvent for solution for injection

Helixate NexGen 2000 IU powder and solvent for solution for injection

Helixate NexGen 3000 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Helixate NexGen 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.

Helixate NexGen 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.

Helixate NexGen 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.

Helixate NexGen 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.

Helixate NexGen 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.

3.LIST OF EXCIPIENTS

Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial with powder for solution for injection.

1 vial with 2.5 mL water for injections.

1 vial with 5 mL water for injections.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use, single dose administration 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

EXP (End of the 12 month period, if stored at room temperature): ...........

Do not use after this date.

May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label. Note the new expiry date on the top of the carton. After reconstitution, the product must be used within 3 hours. Do not refrigerate after reconstitution.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the vials in the outer carton 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

Any unused solution must be discarded.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bayer AG

51368 Leverkusen

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/144/001 - Helixate NexGen 250 IU

EU/1/00/144/002 - Helixate NexGen 500 IU

EU/1/00/144/003 - Helixate NexGen 1000 IU

EU/1/00/144/004 - Helixate NexGen 2000 IU

EU/1/00/144/005 - Helixate NexGen 3000 IU

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Helixate NexGen 250

Helixate NexGen 500

Helixate NexGen 1000

Helixate NexGen 2000

Helixate NexGen 3000

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 WITH POWDER FOR SOLUTION FOR INJECTION

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

Helixate NexGen 250 IU powder for solution for injection

Helixate NexGen 500 IU powder for solution for injection

Helixate NexGen 1000 IU powder for solution for injection

Helixate NexGen 2000 IU powder for solution for injection

Helixate NexGen 3000 IU powder for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Intravenous use.

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU (octocog alfa) (100 IU/mL after reconstitution).

500 IU (octocog alfa) (200 IU/mL after reconstitution).

1000 IU (octocog alfa) (400 IU/mL after reconstitution).

2000 IU (octocog alfa) (400 IU/mL after reconstitution).

3000 IU (octocog alfa) (600 IU/mL after reconstitution).

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL WITH 2.5 mL or 5 mL WATER FOR INJECTIONS

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

Water for injections

2. METHOD OF ADMINISTRATION

For reconstitution of Helixate NexGen, see package leaflet. Use entire content.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 mL [for reconstitution of strengths 250/500/1000 IU]

5 mL [for reconstitution of strengths 2000/3000 IU]

6. OTHER

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