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Soliris (eculizumab) – Labelling - L04AA25

Updated on site: 10-Oct-2017

Medication nameSoliris
ATC CodeL04AA25
Substanceeculizumab
ManufacturerAlexion Europe SAS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton Label

1.NAME OF THE MEDICINAL PRODUCT

Soliris 300 mg concentrate for solution for infusion

Eculizumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of 30 ml contains 300 mg of eculizumab (10mg/ml)

Eculizumab is a humanised monoclonal IgG2/4 k antibody produced in NS0 cell line by recombinant DNA technology.

After dilution, the final concentration of the solution to be infused is 5 mg/ml.

3.LIST OF EXCIPIENTS

Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections. See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 1 vial of 30 ml (10 mg/ml)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use.

Must be diluted before 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

After dilution, the medicinal product should be used within 24 hours.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2 C – 8 C).

Do not freeze.

Store in the original package in order to protect from light.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder: Alexion Europe SAS

1-15, avenue Edouard Belin

92500 Rueil-Malmaison France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/393/001

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

Single use Type I glass vial

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

Soliris 300 mg concentrate for solution for infusion

Eculizumab

For intravenous use

2.METHOD OF ADMINISTRATION

To be diluted before use.

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 ml (10 mg/ml)

6.OTHER

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