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Hexyon (diphtheria toxoid/ tetanus toxoid/ two-component...) – Labelling - J07CA09

Updated on site: 07-Oct-2017

Medication nameHexyon
ATC CodeJ07CA09
Substancediphtheria toxoid/ tetanus toxoid/ two-component acellular pertussis (pertussis toxoidand filamentous haemagglutinin)/ inactivated poliomyelitis virus types 1, 2 and 3 /Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated
ManufacturerSanofi Pasteur Europe

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Hexyon – Carton for pre-filled syringe without needle. Pack of 1, 10 or 50. Hexyon – Carton for pre-filled syringe with one separate needle. Pack of 1 or 10. Hexyon – Carton for pre-filled syringe with two separate needles. Pack of 1 or 10.

1.NAME OF THE MEDICINAL PRODUCT

Hexyon suspension for injection in pre-filled syringe

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

DTaP-IPV-HB-Hib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (0.5 ml) contains:

 

Diphtheria Toxoid

≥ 20 IU

 

Tetanus Toxoid

≥ 40 IU

 

Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin

25/25 µg

 

40/8/32 DU

 

Hepatitis B surface antigen

10 µg

 

Haemophilus influenzae type b polysaccharide

12 µg

 

conjugated to Tetanus protein

22-36 µg

3.LIST OF EXCIPIENTS

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Trometamol

Saccharose

Essential amino acids including L-phenylalanine

Water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in pre-filled syringe. 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 50 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle

10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Shake 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

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vaccine 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

Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/829/002

EU/1/13/829/003

EU/1/13/829/004

EU/1/13/829/005

EU/1/13/829/006

EU/1/13/829/007

EU/1/13/829/008

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:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Hexyon – Carton for pre-filled syringe without needle. Multipack of 50 (5x10) (including blue box)

1. NAME OF THE MEDICINAL PRODUCT

Hexyon suspension for injection in pre-filled syringe

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

DTaP-IPV-HB-Hib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (0.5 ml) contains:

 

Diphtheria Toxoid

≥ 20 IU

 

Tetanus Toxoid

≥ 40 IU

 

Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin

25/25 µg

 

40/8/32 DU

 

Hepatitis B surface antigen

10 µg

 

Haemophilus influenzae type b polysaccharide

12 µg

 

conjugated to Tetanus protein

22-36 µg

3. LIST OF EXCIPIENTS

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Trometamol

Saccharose

Essential amino acids including L-phenylalanine

Water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in pre-filled syringe.

Multipack: 50 (5 packs of 10) pre-filled syringes (0.5ml) without needle.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Shake 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

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vaccine 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

Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/829/009

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:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Hexyon – Carton for pre-filled syringe without needle. Pack of 10 for multipack (without blue box)

1. NAME OF THE MEDICINAL PRODUCT

Hexyon suspension for injection in pre-filled syringe

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

DTaP-IPV-HB-Hib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (0.5 ml) contains:

 

Diphtheria Toxoid

≥ 20 IU

 

Tetanus Toxoid

≥ 40 IU

 

Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin

25/25 µg

 

40/8/32 DU

 

Hepatitis B surface antigen

10 µg

 

Haemophilus influenzae type b polysaccharide

12 µg

 

conjugated to Tetanus protein

22-36 µg

3. LIST OF EXCIPIENTS

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Trometamol

Saccharose

Essential amino acids including L-phenylalanine

Water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in pre-filled syringe. 10 pre-filled syringes (0.5ml) without needle.

Component of a multipack, cannot be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Shake 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

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vaccine 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

Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/829/009

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:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Hexyon – Carton for vial. Pack of 10.

1. NAME OF THE MEDICINAL PRODUCT

Hexyon suspension for injection

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

DTaP-IPV-HB-Hib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One dose (0.5 ml) contains:

 

Diphtheria Toxoid

≥ 20 IU

 

Tetanus Toxoid

≥ 40 IU

 

Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin

25/25 µg

 

40/8/32 DU

 

Hepatitis B surface antigen

10 µg

 

Haemophilus influenzae type b polysaccharide

12 µg

 

conjugated to Tetanus protein

22-36 µg

3. LIST OF EXCIPIENTS

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Trometamol

Saccharose

Essential amino acids including L-phenylalanine

Water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. 10 vials (0.5 ml)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

Shake 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

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vaccine 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

Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/829/001

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 SMALL IMMEDIATE PACKAGING UNITS

Label – Pre-filled syringe

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

Hexyon suspension for injection

DTaP-IPV-HB-Hib

IM

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

Sanofi Pasteur Europe

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Label – Vial

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

Hexyon suspension for injection

DTaP-IPV-HB-Hib

IM

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

Sanofi Pasteur Europe

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