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Zostavax (varicella-zoster virus (live, attenuated)) – Labelling - J07BK02

Updated on site: 11-Oct-2017

Medication nameZostavax
ATC CodeJ07BK02
Substancevaricella-zoster virus (live, attenuated)
ManufacturerMSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

ZOSTAVAX - Powder in vial and solvent in vial - Pack of 1, 10

1.NAME OF THE MEDICINAL PRODUCT

ZOSTAVAX powder and solvent for suspension for injection shingles (herpes zoster) vaccine (live)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.65 mL) contains:

Varicella-zoster virus, Oka/Merck strain, (live, attenuated) ≥19400 PFU

3.LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection 1 vial (powder) + 1 vial (solvent)

10 vials (powder) + 10 vials (solvent)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intramuscular 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

EXP

9.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial in the outer carton to protect from light. After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.

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/1/06/341/001 – pack of 1

EU/1/06/341/002 – pack of 10

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 OF POWDER

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

ZOSTAVAX powder for injection

SC/IM

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6.OTHER

MSD VACCINS

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL OF SOLVENT

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

Solvent for ZOSTAVAX

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with attached needle Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.65 mL) contains:

Varicella-zoster virus, Oka/Merck strain, (live, attenuated) ≥19,400 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe with needle (solvent)

10 vials (powder) + 10 pre-filled syringes with needle (solvent)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intramuscular 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

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial in the outer carton to protect from light.

After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.

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/1/06/341/003 – pack of 1

EU/1/06/341/004 – pack of 10

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

ZOSTAVAX - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1dose (0.65 mL) contains:

Varicella-zoster virus, Oka/Merck strain, (live, attenuated) ≥19,400 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe without needle (solvent)

10 vials (powder) + 10 pre-filled syringes without needle (solvent) 20 vials (powder) + 20 pre-filled syringes without needle (solvent)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intramuscular 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

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial in the outer carton to protect from light.

After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.

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/1/06/341/005 – pack of 1

EU/1/06/341/006 – pack of 10

EU/1/06/341/007 – pack of 20

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

ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with one unattached needle - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1dose (0.65 mL) contains:

Varicella-zoster virus Oka/Merck strain, (live, attenuated) ≥19,400 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 needle

10 vials (powder) + 10 pre-filled syringes (solvent) + 10 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 20 needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intramuscular 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

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial in the outer carton to protect from light.

After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.

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/1/06/341/008 - pack of 1

EU/1/06/341/009 - pack of 10

EU/1/06/341/010 - pack of 20

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

ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.65 mL) contains:

Varicella-zoster virus Oka/Merck strain, (live, attenuated) ≥19,400 PFU

3. LIST OF EXCIPIENTS

Sucrose, hydrolysed gelatin, urea, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 2 needles

10 vials (powder) + 10 pre-filled syringes (solvent) + 20 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 40 needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous or intramuscular 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

EXP

9. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze. Keep the vial in the outer carton to protect from light.

After reconstitution, use immediately or within 30 minutes if stored at 20°C-25°C.

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/1/06/341/011 – pack of 1

EU/1/06/341/012 – pack of 10

EU/1/06/341/013– pack of 20

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 OF POWDER

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

ZOSTAVAX powder for injection

SC/IM

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

MSD VACCINS

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE OF SOLVENT

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

Solvent for ZOSTAVAX

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose

6. OTHER

MSD VACCINS

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