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BeneFIX (nonacog alfa) – Labelling - B02BD04

Updated on site: 05-Oct-2017

Medication nameBeneFIX
ATC CodeB02BD04
Substancenonacog alfa
ManufacturerPfizer Ltd  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 vial: 250 IU nonacog alfa (approx. 50 IU/ml after reconstitution). 1 vial: 500 IU nonacog alfa (approx. 100 IU/ml after reconstitution). 1 vial: 1000 IU nonacog alfa (approx. 200 IU/ml after reconstitution). 1 vial: 1500 IU nonacog alfa (approx. 300 IU/ml after reconstitution). 1 vial: 2000 IU nonacog alfa (approx. 400 IU/ml after reconstitution). 1 vial: 3000 IU nonacog alfa (approx. 600 IU/ml after reconstitution).

3.LIST OF EXCIPIENTS

Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

1 vial with 250 IU nonacog alfa

1 vial with 500 IU nonacog alfa

1 vial with 1000 IU nonacog alfa

1 vial with 1500 IU nonacog alfa

1 vial with 2000 IU nonacog alfa

1 vial with 3000 IU nonacog alfa

1 pre-filled syringe with 5 ml solvent

1 sterile vial adapter reconstitution device

1 sterile infusion set

2 alcohol swabs

1 plaster

1 gauze pad

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use, single use 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

Use only the pre-filled syringe of solvent provided in the box for reconstitution.

8.EXPIRY DATE

EXP

Use immediately or within 3 hours of reconstitution.

9.SPECIAL STORAGE CONDITIONS

Store below 30°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

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/97/047/004

EU/1/97/047/005

EU/1/97/047/006

EU/1/97/047/009

EU/1/97/047/007

EU/1/97/047/008

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

BeneFIX 250

BeneFIX 500

BeneFIX 1000

BeneFIX 1500

BeneFIX 2000

BeneFIX 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 LABEL

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

BeneFIX 250 IU powder for solution for injection

BeneFIX 500 IU powder for solution for injection

BeneFIX 1000 IU powder for solution for injection

BeneFIX 1500 IU powder for solution for injection

BeneFIX 2000 IU powder for solution for injection

BeneFIX 3000 IU powder for solution for injection

Nonacog alfa (recombinant coagulation factor IX)

Intravenous use

2.METHOD OF ADMINISTRATION

Single use injection.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

See front label (Lot, Exp.)

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU

500 IU

1000 IU

1500 IU

2000 IU

3000 IU

6.OTHER

Store below 30 ºC. Do not freeze.

Use only the pre-filled syringe provided in the box for reconstitution.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SOLVENT SYRINGE LABEL

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

Solvent for BeneFIX

For intravenous use.

2. METHOD OF ADMINISTRATION

Use the entire contents.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

Pfizer Limited

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 5 ml of 0.234% sodium chloride solution for injection

6. OTHER

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