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Elaprase (idursulfase) – Labelling - A16AB09

Updated on site: 06-Oct-2017

Medication nameElaprase
ATC CodeA16AB09
Substanceidursulfase
ManufacturerShire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sweden

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Elaprase 2 mg/ml concentrate for solution for infusion idursulfase

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase

3.LIST OF EXCIPIENTS

Polysorbate 20

Sodium chloride

Dibasic sodium phosphate heptahydrate

Monobasic sodium phosphate monohydrate

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

3ml

4x 3 ml

10x 3 ml

6 mg/3 ml

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

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

Shire Human Genetic Therapies AB

Vasagatan 7

111 20 Stockholm

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/365/001

EU/1/06/365/002

EU/1/06/365/003

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

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

Elaprase 2 mg/ml sterile concentrate idursulfase

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6 mg/3 ml

6.OTHER

Store in a refrigerator

Do not freeze

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