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Imvanex (modified vaccinia Ankara - Bavarian...) – Labelling - J07BX

Updated on site: 08-Oct-2017

Medication nameImvanex
ATC CodeJ07BX
Substancemodified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus
ManufacturerBavarian Nordic A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK OF 20 VIALS

1.NAME OF THE MEDICINAL PRODUCT

IMVANEX suspension for injection

Smallpox vaccine (Live Modified Vaccinia Virus Ankara)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) has a titre of no less than 5 x 107 TCID50 (TCID50 = Tissue Culture Infectious Dose)

3.LIST OF EXCIPIENTS

Trometamol

Sodium chloride

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection.

20 single dose vials.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Thaw at room temperature. Gently swirl for at least 30 seconds.

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. (-20°C: +/-5°C):

Exp. (-50°C +/-10°C):

Exp. (-80°C +/-10°C):

9.SPECIAL STORAGE CONDITIONS

Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C) protected from light. Expiry date depends on storage temperature.

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

Dispose of in accordance with local requirement.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Bavarian Nordic A/S

Hejreskovvej 10a

3490 Kvistgaard

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/855/001

13.BATCH NUMBER<, DONATION AND PRODUCT CODES>

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

IMVANEX® suspension for injection

Smallpox vaccine

2.METHOD OF ADMINISTRATION

Subcutaneous use

3.EXPIRY DATE

Exp. (-20°C: +/-5°C):

Exp. (-50°C +/-10°C):

Exp. (-80°C +/-10°C):

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

6.OTHER

Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C) protected from light.

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