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Adjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (split influenza virus, inactivated,...) – Labelling - J07BB02

Updated on site: 05-Oct-2017

Medication nameAdjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
ATC CodeJ07BB02
Substancesplit influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
ManufacturerGlaxoSmithKline Biologicals S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION

1.NAME OF THE MEDICINAL PRODUCT

Adjupanrix suspension and emulsion for emulsion for injection.

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

After mixing, 1 dose (0.5 ml) contains:

Split influenza virus inactivated, containing antigen equivalent to:

A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

3.75 micrograms*

AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80

* haemagglutinin

3.LIST OF EXCIPIENTS

Polysorbate 80

Octoxynol 10

Thiomersal

Sodium chloride (NaCl)

Disodium hydrogen phosphate (Na2HPO4)

Potassium dihydrogen phosphate (KH2PO4)

Potassium chloride (KCl)

Magnesium chloride (MgCl2)

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension and emulsion for emulsion for injection

50 vials: suspension (antigen)

50 vials: emulsion (adjuvant)

The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine

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

Suspension and emulsion to be mixed before administration

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

Dispose of in accordance with local regulations

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart, Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/578/001

13.BATCH NUMBER

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK OF 50 VIALS OF SUSPENSION

1. NAME OF THE MEDICINAL PRODUCT

Suspension for emulsion for injection for Adjupanrix

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose

*Antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

3. LIST OF EXCIPIENTS

Excipients:

Polysorbate 80

Octoxynol 10

Thiomersal

Sodium chloride

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Potassium chloride

Magnesium chloride

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Antigen suspension for injection 50 vials: suspension

2.5 ml per vial.

After mixing with adjuvant emulsion: 10 doses of 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

Suspension to be exclusively mixed with adjuvant emulsion before administration

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 Biologicals, Rixensart - Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/578/001

13. BATCH NUMBER

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK OF 25 VIALS OF EMULSION

1. NAME OF THE MEDICINAL PRODUCT

Emulsion for emulsion for injection for Adjupanrix

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)

3. LIST OF EXCIPIENTS

Excipients:

Sodium chloride

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Potassium chloride

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Adjuvant emulsion for injection 25 vials: emulsion

2.5 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

Emulsion to be exclusively mixed with antigen suspension before administration

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 Biologicals, Rixensart - Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/578/001

13. BATCH NUMBER

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

SUSPENSION VIAL

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

Antigen suspension for

Adjupanrix

A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

I.M.

2.METHOD OF ADMINISTRATION

Mix with adjuvant emulsion before use

3.EXPIRY DATE

EXP

After mixing: Use within 24 hours and do not store above 25°C.

Date and time of mixing:

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

After mixing with adjuvant emulsion: 10 doses of 0.5 ml

6.OTHER

Storage (2ºC-8ºC), do not freeze, protect from light

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

EMULSION VIAL

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

Adjuvant emulsion for

Adjupanrix

I.M.

2. METHOD OF ADMINISTRATION

Mix into Antigen suspension before use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

6. OTHER

Storage (2ºC-8ºC), do not freeze, protect from light

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