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Bexsero (recombinant Neisseria meningitidis group-B...) – Labelling - J07AH09

Updated on site: 05-Oct-2017

Medication nameBexsero
ATC CodeJ07AH09
Substancerecombinant Neisseria meningitidis group-B NHBA fusion protein /recombinant Neisseria meningitidis group-B NadA protein /recombinant Neisseria meningitidis group B fHbp fusion protein /outer membrane vesiclesfrom Neisseria meningitidis group-B strain NZ98
ManufacturerGSK Vaccines S.r.l.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Bexsero suspension for injection in pre-filled syringe

Meningococcal Group B Vaccine (rDNA, component, adsorbed)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

0.5 ml dose contains:

 

Recombinant Neisseria meningitidis group B NHBA/NadA/fHbp proteins

50/50/50 micrograms

Outer membrane vesicles (OMV) from Neisseria meningitidis group B

25 micrograms

strain NZ98/254 measured as amount of total protein containing the PorA P1.4

 

Adsorbed on aluminium hydroxide (0.5 mg Al³+).

 

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

Excipients: sodium chloride, histidine, sucrose, water for injections.

 

 

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Suspension for injection (0.5 ml)

 

 

 

 

 

1 pre-filled syringe containing 0.5 ml suspension with needles

 

 

1 pre-filled syringe containing 0.5 ml suspension without needle

 

 

 

 

 

 

 

 

10 pre-filled syringes each containing 0.5 ml suspension with needles

 

 

 

 

10 pre-filled syringes each containing 0.5 ml suspension without needle

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

Intramuscular use only.

Shake well before use.

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.

Store in the original package 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

GSK Vaccines S.r.l.,

Via Fiorentina 1,

53100 Siena,

Italy

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/812/001

EU/1/12/812/002

EU/1/12/812/003

EU/1/12/812/004

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 PRE-FILLED SYRINGE

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

Bexsero suspension for injection

Meningococcal B vaccine

IM use

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

6.OTHER

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