English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Defitelio (defibrotide) – Labelling - B01AX01

Updated on site: 06-Oct-2017

Medication nameDefitelio
ATC CodeB01AX01
Substancedefibrotide
ManufacturerGentium S.r.l.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1.NAME OF THE MEDICINAL PRODUCT

Defitelio 80 mg/mL concentrate for solution for infusion defibrotide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each 2.5 mL vial contains 200 mg defibrotide.

3.LIST OF EXCIPIENTS

Also contains: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion 10 vials

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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

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

Gentium Srl

Piazza XX Settembre 2 Villa Guardia

22079 Italy

P: +39 031 5373200 F: +39 031 5373241 info@gentium.it

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/878/001

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

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

Defitelio 80 mg/mL sterile concentrate

Defibrotide

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 mL

6.OTHER

Gentium Srl

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed