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Gardasil 9 (human papillomavirus vaccine [types...) – Labelling - J07BM

Updated on site: 07-Oct-2017

Medication nameGardasil 9
ATC CodeJ07BM
Substancehuman papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
ManufacturerSanofi Pasteur MSD

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT

Single dose vial, pack of 1

1.NAME OF THE MEDICINAL PRODUCT

Gardasil 9 suspension for injection

Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml):

 

HPV Type 6 L1 protein

30 µg

HPV Type 11 and 18 L1 protein

40 µg

HPV Type

16 L1 protein

60 µg

HPV Type

31, 33, 45, 52 and 58 L1 protein

20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.5 mg Al).

3.LIST OF EXCIPIENTS

Excipients: Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 vial (0.5 ml).

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

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

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

Keep the vial 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

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1007/001

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 VIAL LABEL TEXT

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

Gardasil 9

Injection

IM

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

6.OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT

Pre-filled syringe with 2 needles, pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

Gardasil 9 suspension for injection in a pre-filled syringe

Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml):

 

HPV Type 6 L1 protein

30 µg

HPV Type 11 and 18 L1 protein

40 µg

HPV Type

16 L1 protein

60 µg

HPV Type

31, 33, 45, 52 and 58 L1 protein

20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.5 mg Al).

3. LIST OF EXCIPIENTS

Excipients: Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

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

10 pre-filled syringes (0.5 ml) with 2 needles each

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use.

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

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

Keep the syringe 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

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1007/002

EU/1/15/1007/003

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 label text

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

Gardasil 9

Injection

IM

Human Papillomavirus 9-valent Vaccine

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

6. OTHER

MSD VACCINS

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