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Fabrazyme (agalsidase beta) – Labelling - A16AB04

Updated on site: 06-Oct-2017

Medication nameFabrazyme
ATC CodeA16AB04
Substanceagalsidase beta
ManufacturerGenzyme Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)

1.NAME OF THE MEDICINAL PRODUCT

Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 35 mg of agalsidase beta.

3.LIST OF EXCIPIENTS

Excipients: mannitol

sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder for concentrate for solution for infusion. 5 vials of powder for concentrate for solution for infusion.

10 vials of powder for concentrate for solution for infusion.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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 (2 C – 8 C).

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused solution should be discarded.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411DD Naarden - NL

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Fabrazyme 35 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL

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

Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta

Intravenous use.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

Genzyme Europe B.V.-NL

Store in a refrigerator (2 C – 8 C).

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)

1. NAME OF THE MEDICINAL PRODUCT

Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 5 mg of agalsidase beta.

3. LIST OF EXCIPIENTS

Excipients: mannitol

sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder for concentrate for solution for infusion. 5 vials of powder for concentrate for solution for infusion. 10 vials of powder for concentrate for solution for infusion.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For single use only.

Read the package leaflet before use.

Intravenous 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 (2 C – 8 C).

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused solution should be discarded.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V.

Gooimeer 10

1411DD Naarden - NL

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Fabrazyme 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL

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

Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

Genzyme Europe B.V.- NL

Store in a refrigerator (2 C – 8 C)

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