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Cervarix (human papillomavirus1 type 16 L1 protein...) – Labelling - J07BM02

Updated on site: 05-Oct-2017

Medication nameCervarix
ATC CodeJ07BM02
Substancehuman papillomavirus1 type 16 L1 protein / human papillomavirus type 18 L1 protein
ManufacturerGlaxoSmithKline Biologicals S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MONODOSE VIAL, PACK OF 1, 10, 100

1.NAME OF THE MEDICINAL PRODUCT

Cervarix suspension for injection

Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

 

1 dose (0.5 ml) contains:

 

 

 

HPV type 16 L1 protein1,2

20 micrograms

 

HPV type 18 L1 protein1,2

20 micrograms

 

1 adjuvanted by AS04 containing:

 

 

 

3-O-desacyl-4’- monophosphoryl lipid A (MPL)2

50 micrograms

 

2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)

0.5 milligrams Al3+ in total

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

Sodium chloride

 

 

 

Sodium dihydrogen phosphate dihydrate

 

 

 

Water for injections

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

Suspension for injection

 

 

 

1 vial

 

 

 

 

1 dose (0.5 ml)

 

 

 

 

 

 

 

10 vials

 

 

 

10 x 1 dose (0.5 ml)

 

 

 

 

 

 

 

100 vials

 

 

 

100 x 1 dose (0.5 ml)

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Read the package leaflet before use

Intramuscular use

Shake 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

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/1/07/419/001 – pack of 1

EU/1/07/419/002 – pack of 10

EU/1/07/419/003 – pack of 100

13. BATCH NUMBER

LOT:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

MULTIDOSE VIAL, PACK OF 1, 10, 100

1. NAME OF THE MEDICINAL PRODUCT

Cervarix suspension for injection, multidose

Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

HPV type 16 L1 protein1,2

20 micrograms

HPV type 18 L1 protein1,2

20 micrograms

1 adjuvanted by AS04 containing:

 

3-O-desacyl-4’- monophosphoryl lipid A (MPL)2

50 micrograms

2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)

0.5 milligrams Al3+ in total

 

 

 

3.

LIST OF EXCIPIENTS

 

Sodium chloride

 

Sodium dihydrogen phosphate dihydrate

 

Water for injections

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Suspension for injection

1vial

2doses (1 ml)

10 vials

10 x 2 doses (1 ml)

100 vials

100 x 2 doses (1 ml)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Intramuscular use

Shake 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

After first opening, use immediately or within 6 hours if stored in a refrigerator

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/1/07/419/010 – pack of 1

EU/1/07/419/011 – pack of 10

EU/1/07/419/012 – pack of 100

13. BATCH NUMBER

LOT:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10

1. NAME OF THE MEDICINAL PRODUCT

Cervarix suspension for injection in pre-filled syringe

Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

 

1 dose (0.5 ml) contains:

 

 

 

HPV type 16 L1 protein1,2

20 micrograms

 

HPV type 18 L1 protein1,2

20 micrograms

 

1 adjuvanted by AS04 containing:

 

 

 

3-O-desacyl-4’- monophosphoryl lipid A (MPL)2

50 micrograms

 

2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)

0.5 milligrams Al3+ in total

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

 

Sodium chloride

 

 

 

Sodium dihydrogen phosphate dihydrate

 

 

 

Water for injections

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

 

 

Suspension for injection in pre-filled syringe

 

 

 

1 pre-filled syringe

 

 

 

1 dose (0.5 ml)

 

 

 

 

 

 

 

10 pre-filled syringes

 

 

 

10 x 1 dose (0.5 ml)

 

 

 

 

 

 

 

1 pre-filled syringe + 1 needle

 

 

 

1 dose (0.5 ml)

 

 

 

 

 

 

 

10 pre-filled syringes + 10 needles

 

 

 

10 x 1 dose (0.5 ml)

 

 

 

 

 

 

 

1 pre-filled syringe + 2 needles

 

 

 

1 dose (0.5 ml)

 

 

 

 

 

 

 

10 pre-filled syringes + 20 needles

 

 

 

10 x 1 dose (0.5 ml)

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

Read the package leaflet before use

Intramuscular use

Shake 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

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/1/07/419/008 – pack of 1 without needle

EU/1/07/419/009 – pack of 10 without needle

EU/1/07/419/004 – pack of 1 with 1 needle

EU/1/07/419/006 – pack of 10 with 10 needles

EU/1/07/419/005 – pack of 1 with 2 needles

EU/1/07/419/007 – pack of 10 with 20 needles

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 MONODOSE VIAL LABEL

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

Cervarix

Suspension for injection

I.M.

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

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL LABEL

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

Cervarix

Suspension for injection

I.M.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2 doses (1 ml)

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL

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

Cervarix

Suspension for injection in pre-filled syringe

I.M.

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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