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Pandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune) (reassortant influenza virus (live attenuated)...) – Labelling - J07BB03

Updated on site: 09-Oct-2017

Medication namePandemic influenza vaccine H5N1 AstraZeneca (Pandemic influenza vaccine H5N1 Medimmune)
ATC CodeJ07BB03
Substancereassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
ManufacturerAstraZeneca AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS)

1.NAME OF THE MEDICINAL PRODUCT

Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension

Pandemic influenza vaccine (H5N1) (live attenuated, nasal)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Reassortant influenza virus (live attenuated) of the following strain:

A/Vietnam/1203/2004 (H5N1) strain

(A/Vietnam/1203/2004, MEDI 0141000136)107.0±0.5 FFU per 0.2 ml dose

3.LIST OF EXCIPIENTS

Excipients: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Nasal spray, suspension

10 single-use nasal applicators (0.2 ml each)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For nasal use only. Do not inject.

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

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1089/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS

1. NAME OF THE MEDICINAL PRODUCT

Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (live attenuated, nasal)

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

For nasal use only. Do not inject.

5 single-use nasal applicators (0.2 ml each) Store in a refrigerator. Do not freeze.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SINGLE-USE NASAL APPLICATOR

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

Pandemic influenza vaccine H5N1 AstraZeneca

Pandemic influenza vaccine

2.METHOD OF ADMINISTRATION

For nasal use only.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

LOT

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.2 ml

6.OTHER

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