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Naglazyme (galsulfase) – Labelling - A16AB

Updated on site: 08-Oct-2017

Medication nameNaglazyme
ATC CodeA16AB
Substancegalsulfase
ManufacturerBioMarin Europe Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Naglazyme 1 mg/ml concentrate for solution for infusion

Galsulfase

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of solution contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase.

3.LIST OF EXCIPIENTS

Sodium chloride

Sodium phosphate monobasic monohydrate

Sodium phosphate dibasic heptahydrate

Polysorbate 80

Water for injections

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial of concentrate for solution for infusion

6 vials of concentrate for solution for infusion

5 mg/5 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

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

For single use only

Any unused solution should be discarded

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BioMarin Europe Limited

10 Bloomsbury Way

London, WC1A 2SL

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/05/324/001 1 vial

EU/1/05/324/002 6 vials

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Clear type 1, 5 ml VIAL

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

Naglazyme 1 mg/ml concentrate for solution for infusion

Galsulfase

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

5 mg/5 ml

6.OTHER

Store in a refrigerator

Do not freeze

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