Gardasil (human papillomavirus type 6 L1 protein...) – Labelling - J07BM01

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT

Gardasil, suspension for injection – single dose vial, pack of 1, 10, 20

1.NAME OF THE MEDICINAL PRODUCT

Gardasil, suspension for injection.

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).

3.LIST OF EXCIPIENTS

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

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection. 1 dose vial, 0.5 ml.

10 single dose vials, 0.5 ml each.

20 single dose vials, 0.5 ml each.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) 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/1/06/357/001 – pack of 1

EU/1/06/357/002– pack of 10

EU/1/06/357/018– pack of 20

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

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

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

Gardasil, suspension for injection.

IM use.

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

Gardasil, suspension for injection – pre-filled syringe without needle, pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

Gardasil, suspension for injection in a pre-filled syringe.

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in a pre-filled syringe. 1 dose, 0.5 ml pre-filled syringe without needle.

10 single doses, 0.5 ml pre-filled syringes without needles. 20 single doses, 0.5 ml pre-filled syringes without needles.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) 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/1/06/357/003 – pack of 1

EU/1/06/357/004 – pack of 10

EU/1/06/357/019 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT

Gardasil, suspension for injection – pre-filled syringe with 1 needle, pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

Gardasil, suspension for injection in a pre-filled syringe.

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in a pre-filled syringe. 1 dose, 0.5 ml pre-filled syringe with 1 needle.

10 single doses, 0.5 ml pre-filled syringes with 1 needle each. 20 single doses, 0.5 ml pre-filled syringes with 1 needle each.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) 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/1/06/357/005 – pack of 1

EU/1/06/357/006 – pack of 10

EU/1/06/357/020 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT

Gardasil, suspension for injection – pre-filled syringe with 2 needles, pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

Gardasil, suspension for injection in a pre-filled syringe.

Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg

adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection in a pre-filled syringe. 1 dose, 0.5 ml pre-filled syringe with 2 needles.

10 single doses, 0.5 ml pre-filled syringes with 2 needles each. 20 single doses, 0.5 ml pre-filled syringes with 2 needles each.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular (IM) 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/1/06/357/007 – pack of 1

EU/1/06/357/008 – pack of 10

EU/1/06/357/021 – pack of 20

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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, suspension for injection in a pre-filled syringe.

IM use.

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