English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

M-M-RVaxPro (measles virus Enders Edmonston strain...) – Labelling - J07BD52

Updated on site: 08-Oct-2017

Medication nameM-M-RVaxPro
ATC CodeJ07BD52
Substancemeasles virus Enders Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated)
ManufacturerMSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10

1.NAME OF THE MEDICINAL PRODUCT

M-M-RVAXPRO powder and solvent for suspension for injection Measles, mumps, and rubella vaccine (live)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains:

Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/3 strain (live attenuated)

* 50% cell culture infectious dose

not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*

3.LIST OF EXCIPIENTS

Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

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

10 single dose vials (powder) + 10 vials (solvent).

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous 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 (2°C-8°C) Do not freeze

Keep the vial of powder in the outer carton in order to protect from light

After reconstitution, use immediately or within 8 hours if stored in a refrigerator

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/1/06/337/001 – pack of 1

EU/1/06/337/002 – pack of 10

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS IN 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

M-M-RVAXPRO powder for suspension for injection

2.METHOD OF ADMINISTRATION

IM or SC use

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 M-M-RVAXPRO

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

M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe with attached needle - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

M-M-RVAXPRO powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains:

Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/3 strain (live attenuated)

*50% cell culture infectious dose

not less than 1x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*

3. LIST OF EXCIPIENTS

Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in pre-filled syringe

1 single dose vial (powder) + 1 prefilled syringe (solvent) with needle.

10 single dose vials (powder) + 10 prefilled syringes (solvent) with needle.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous 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 (2°C-8°C) Do not freeze

Keep the vial of powder in the outer carton in order to protect from light

After reconstitution, use immediately or within 8 hours if stored in a refrigerator

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/1/06/337/003 – pack of 1

EU/1/06/337/004 – 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

M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe without needle - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

M-M-RVAXPRO powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains:

Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/3 strain (live attenuated)

*50% cell culture infectious dose

not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*

3. LIST OF EXCIPIENTS

Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in pre-filled syringe

1 single dose vial (powder) + 1 prefilled syringe (solvent) without needle.

10 single dose vials (powder) + 10 prefilled syringes (solvent) without needle. 20 single dose vials (powder) + 20 prefilled syringes (solvent) without needle.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous 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 (2°C-8°C) Do not freeze

Keep the vial of powder in the outer carton in order to protect from light

After reconstitution, use immediately or within 8 hours if stored in a refrigerator

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/1/06/337/005 – pack of 1

EU/1/06/337/006 – pack of 10

EU/1/06/337/007 – 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

M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needle –

Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

M-M-RVAXPRO powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution, 1 dose (0.5 ml) contains:

Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/3 strain (live attenuated)

*50% cell culture infectious dose

not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*

3. LIST OF EXCIPIENTS

Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 1 needle.

10 single dose vials (powder) + 10 prefilled syringes (solvent) + 10 needles. 20 single dose vials (powder) + 20 prefilled syringes (solvent) + 20 needles.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous 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 (2°C-8°C) Do not freeze

Keep the vial of powder in the outer carton in order to protect from light

After reconstitution, use immediately or within 8 hours if stored in a refrigerator

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/1/06/337/008 – pack of 1

EU/1/06/337/009 – pack of 10

EU/1/06/337/010 – 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

M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needles - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

M-M-RVAXPRO powder and solvent for suspension for injection in pre-filled syringe Measles, mumps, and rubella vaccine (live)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

After reconstitution,1 dose (0.5 ml) contains:

Measles virus Enders’ Edmonston strain (live attenuated) Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) Rubella virus Wistar RA 27/3 strain (live attenuated)

*50% cell culture infectious dose

not less than 1 x103 CCID50* not less than 12,5 x103 CCID50* not less than 1 x103 CCID50*

3. LIST OF EXCIPIENTS

Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles.

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

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous 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 (2°C-8°C) Do not freeze

Keep the vial of powder in the outer carton in order to protect from light

After reconstitution, use immediately or within 8 hours if stored in a refrigerator

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/1/06/337/011 – pack of 1

EU/1/06/337/012 – pack of 10

EU/1/06/337/013 – 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

M-M-RVAXPRO powder for suspension for injection in pre-filled syringe

2. METHOD OF ADMINISTRATION

IM or SC use

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 M-M-RVAXPRO

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

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed