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Adcetris (brentuximab vedotin) – Labelling - L01XC12

Updated on site: 11-Jul-2017

Medication nameAdcetris
ATC CodeL01XC12
Substancebrentuximab vedotin
ManufacturerTakeda Pharma A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

ADCETRIS 50 mg powder for concentrate for solution for infusion brentuximab vedotin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 50 mg of brentuximab vedotin

After reconstitution each vial contains 5 mg/ml of brentuximab vedotin

3.LIST OF EXCIPIENTS

Excipients: Citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, polysorbate 80 See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion

1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For intravenous use after reconstitution and dilution

Read the package leaflet

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

Keep the vial in the outer carton 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

For single use only

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Takeda Pharma A/S

Dybendal Alle 10

2630 Taastrup

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/794/001

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

VIAL LABEL

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

ADCETRIS 50 mg powder for concentrate for solution for infusion brentuximab vedotin

IV use

2.METHOD OF ADMINISTRATION

For intravenous use after reconstitution and dilution

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg

6.OTHER

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