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Unituxin (dinutuximab) – Labelling - L01XC

Updated on site: 10-Oct-2017

Medication nameUnituxin
ATC CodeL01XC
Substancedinutuximab
ManufacturerUnited Therapeutics Europe Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton

1. NAME OF THE MEDICINAL PRODUCT

Unituxin 3.5 mg/mL concentrate for solution for infusion dinutuximab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 mL of concentrate contains 3.5 mg of dinutuximab. Each 5 mL vial contains 17.5 mg of dinutuximab.

3. LIST OF EXCIPIENTS

 

Histidine

 

authorised

 

 

 

 

Polysorbate 20

 

 

 

Sodium chloride

 

 

 

Water for injections

 

 

 

See leaflet for further information.

 

 

 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS

 

 

Concentrate for solution for infusion

longer

 

 

 

1 vial

5. METHOD AND ROUTE(S) OF

productADMINISTRATIONFor intravenous use.no17.5 mg/5 mL

Read the package leafletMedicinalbefore 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 and transport refrigerated

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

United Therapeutics Europe, Ltd.

Unither House

Curfew Bell Road

Chertsey, Surrey KT16 9FG

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1022/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

no

 

 

product

 

Justification for not including Braille accepted

 

 

Medicinal

 

 

 

longer

authorised

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Unituxin 3.5 mg/mL sterile concentrate dinutuximab

Intravenous use after dilution

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

17.5 mg/5 mL

 

 

no

longer

 

 

 

6.

OTHER

 

 

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

authorised

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