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Quintanrix (diphtheria toxoid / tetanus toxoid /...) – Labelling - J07CA10

Updated on site: 09-Oct-2017

Medication nameQuintanrix
ATC CodeJ07CA10
Substancediphtheria toxoid / tetanus toxoid / inactivated Bordetella pertussis / hepatitis B surface antigen (rDNA) / Haemophilus influenzae type b polysaccharide
ManufacturerGlaxoSmithKline Biologicals S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MONODOSE PRESENTATIONS

1. NAME OF THE MEDICINAL PRODUCT

Quintanrix powder and suspension for suspension for injection

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

After reconstitution, 1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

 

 

 

≥ 30 IU

Tetanus toxoid1

 

 

 

≥ 60 IU

Inactivated Bordetella pertussis

 

authorised

 

 

 

 

≥ 4 IU

Hepatitis B surface antigen (rDNA) 2, 3

 

10 µg

Haemophilus influenzae type b polysaccharide

 

 

(polyribosylribitol phosphate) 2

 

 

2.5 µg

conjugated to tetanus toxoid as a carrier

 

5-10 µg

1 adsorbed on aluminium hydroxide, hydrated

 

Total: 0.26 mg Al3+

2adsorbed on aluminium phosphate

 

Total: 0.40 mg Al3+

produced in Saccharomyces cerevisae cells by recombinantlongerDNA technology

3.

LIST OF EXCIPIENTS

 

no

 

Lactose

 

 

 

 

Thiomersal

 

 

 

 

Sodium chloride

 

 

 

 

Water for injections

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

Powder and suspension for suspension for injection

 

1 Vial: Powder

Product

 

 

 

 

 

 

1 Vial: Suspension

 

 

 

 

1 dose (0.5 ml)

 

 

 

 

100 x 1 dose (0.5 ml)

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

intramuscular use

 

 

 

 

Shake well before use

 

 

 

 

 

Medicinal

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

authorised

9. SPECIAL STORAGE CONDITIONS

10.SPECIAL PRECAUTIONS FOR DISPOSAL OFlongerUNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a.

no

 

Rue de l’Institut 89

Product

 

B-1330 Rixensart, Belgium

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/301/001

 

 

EU/1/04/301/002

 

 

 

 

13.

MANUFACTURER’S BATCH NUMBER

 

Medicinal

 

 

LOT:

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS

1. NAME OF THE MEDICINAL PRODUCT

Quintanrix powder and suspension for suspension for injection, multidose

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

After reconstitution, 1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

 

 

 

≥ 30 IU

Tetanus toxoid1

 

 

 

≥ 60 IU

Inactivated Bordetella pertussis

 

authorised

 

 

 

 

≥ 4 IU

Hepatitis B surface antigen (rDNA) 2, 3

 

10 µg

Haemophilus influenzae type b polysaccharide

 

 

(polyribosylribitol phosphate) 2

 

 

2.5 µg

conjugated to tetanus toxoid as a carrier

 

5-10 µg

1 adsorbed on aluminium hydroxide, hydrated

 

Total: 0.26 mg Al3+

2adsorbed on aluminium phosphate

 

Total: 0.40 mg Al3+

3 produced in Saccharomyces cerevisae cells by recombinantlongerDNA technology

3.

LIST OF EXCIPIENTS

 

no

 

Lactose

 

 

 

 

Thiomersal

 

 

 

 

Sodium chloride

 

 

 

 

Water for injections

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

Powder and suspension for suspension for injection

 

1 Vial: Powder

Product

 

 

 

 

 

 

1 Vial: Suspension

 

 

 

 

2 doses (1 ml)

 

 

 

 

100 x 2 doses (1 ml)

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

intramuscular use

 

 

 

 

Shake well before use

 

 

 

 

 

Medicinal

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATEauthorised

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OFlongerUNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a.

no

 

Rue de l’Institut 89

Product

 

B-1330 Rixensart, Belgium

 

 

 

 

 

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/301/003

 

 

EU/1/04/301/004

 

 

 

 

13.

MANUFACTURER’S BATCH NUMBER

 

Medicinal

 

 

LOT:

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

 

 

 

15.

INSTRUCTIONS ON USE

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS

1. NAME OF THE MEDICINAL PRODUCT

Quintanrix powder and suspension for suspension for injection, multidose

Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

After reconstitution, 1 dose (0.5 ml) contains:

 

 

Diphtheria toxoid1

 

 

 

≥ 30 IU

Tetanus toxoid1

 

 

 

≥ 60 IU

Inactivated Bordetella pertussis

 

authorised

 

 

 

 

≥ 4 IU

Hepatitis B surface antigen (rDNA) 2, 3

 

10 µg

Haemophilus influenzae type b polysaccharide

 

 

(polyribosylribitol phosphate) 2

 

 

2.5 µg

conjugated to tetanus toxoid as a carrier

 

5-10 µg

1 adsorbed on aluminium hydroxide, hydrated

 

Total: 0.26 mg Al3+

2adsorbed on aluminium phosphate

 

Total: 0.40 mg Al3+

3 produced in Saccharomyces cerevisae cells by recombinantlongerDNA technology

3.

LIST OF EXCIPIENTS

 

no

 

Lactose

 

 

 

 

Thiomersal

 

 

 

 

Sodium chloride

 

 

 

 

Water for injections

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

Powder and suspension for suspension for injection

 

1 Vial: Powder

Product

 

 

 

 

 

 

1 Vial: Suspension

 

 

 

 

50 x 10 doses (5 ml)

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

intramuscular use

 

 

 

 

Shake well before use

 

 

 

 

 

 

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

 

Medicinal

 

 

 

 

 

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATEauthorised

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OFlongerUNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Rue de l’Institut 89

 

no

 

 

B-1330 Rixensart, Belgium

 

 

 

 

 

 

 

12.

 

 

Product

 

 

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/301/005

 

 

13.

 

MANUFACTURER’S BATCH NUMBER

LOT:

 

 

 

 

 

 

 

14.

Medicinal

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.

 

INSTRUCTIONS ON USE

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MONODOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

longer

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

 

Product

no

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MONODOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT1 dose

 

Product

no

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT2 doses (1 ml)

 

Product

no

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT2 doses

 

Product

no

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT10 doses (5 ml)

 

Product

no

Medicinal

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS

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

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBERlonger

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT10 doses

 

Product

no

Medicinal

 

 

 

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