Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE CONDITIONS
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 2. METHOD OF ADMINISTRATION
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
- 6. OTHER

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,
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 –
1. NAME OF THE MEDICINAL PRODUCT
Gardasil, suspension for injection in a
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
- Rotateq - MSD VACCINS
- Hbvaxpro - MSD VACCINS
- Zostavax - MSD VACCINS
- M-m-rvaxpro - MSD VACCINS
Prescription drugs listed. Manufacturer: "MSD VACCINS"
adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
3. LIST OF EXCIPIENTS
Sodium chloride,
4. PHARMACEUTICAL FORM AND CONTENTS
Suspension for injection in a
10 single doses, 0.5 ml
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 –
1. NAME OF THE MEDICINAL PRODUCT
Gardasil, suspension for injection in a
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,
4. PHARMACEUTICAL FORM AND CONTENTS
Suspension for injection in a
10 single doses, 0.5 ml
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
- Silgard - J07BM01
Prescription drugs listed. ATC Code: "J07BM01"
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 –
1. NAME OF THE MEDICINAL PRODUCT
Gardasil, suspension for injection in a
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,
4. PHARMACEUTICAL FORM AND CONTENTS
Suspension for injection in a
10 single doses, 0.5 ml
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
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Gardasil, suspension for injection in a
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
- Movymia
- Cerezyme
- Clopidogrel teva pharma b.v.
- Travatan
- Mycophenolate mofetil teva
- Triumeq
Prescription drugs listed:
MSD VACCINS
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