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Blincyto (blinatumomab) – Labelling - L01XC

Updated on site: 05-Oct-2017

Medication nameBlincyto
ATC CodeL01XC
Substanceblinatumomab
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion blinatumomab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 38.5 micrograms of blinatumomab.

After reconstitution with water for injections each vial contains 12.5 micrograms/mL of blinatumomab.

3.LIST OF EXCIPIENTS

Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.

Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate and solution for solution for infusion 1 vial of powder.

1 vial of solution (stabiliser). Add to the sodium chloride bag only.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use after reconstitution and dilution.

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

Do not shake the reconstituted solution.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Store in the original 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

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1047/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

POWDER VIAL

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

BLINCYTO 38.5 mcg powder for concentrate blinatumomab

IV after reconstitution and dilution

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SOLUTION (STABILISER) VIAL

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

Solution (stabiliser).

BLINCYTO

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

6. OTHER

Add to the sodium chloride bag only.

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