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Obizur (susoctocog alfa) – Labelling - B02

Updated on site: 08-Oct-2017

Medication nameObizur
ATC CodeB02
Substancesusoctocog alfa
ManufacturerBaxalta Innovations GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

OBIZUR 500 U powder and solvent for solution for injection susoctocog alfa

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains approximately 500 U of antihaemophilic factor VIII (recombinant), porcine sequence, susoctocog alfa after reconstitution.

3.LIST OF EXCIPIENTS

Excipients:

Polysorbate 80

Sodium chloride

Calcium chloride dihydrate

Sucrose

Tris Base

Tris HCl

Tri-sodium citrate dihydrate

Read the package leaflet before use.

4.PHARMACEUTICAL FORM AND CONTENTS

One, five, ten vials

One, five, ten pre-filled syringes with solvent

One, five, ten vial adapters

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For 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 WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP:

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Use immediately or within 3 hours after reconstitution.

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

Baxalta Innovations GmbH

A-1221 Vienna

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1035/001

EU/1/15/1035/002

EU/1/15/1035/003

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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 FOR THE POWDER

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

OBIZUR 500 U powder for solution for injection

Susoctocog alfa

IV

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

Single use injection.

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 U

6.OTHER

Baxalta Logo

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE LABEL FOR THE SOLVENT

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

Solvent for Obizur water for injections.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

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