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ViraferonPeg (peginterferon alfa-2b) – Labelling - L03AB10

Updated on site: 10-Oct-2017

Medication nameViraferonPeg
ATC CodeL03AB10
Substancepeginterferon alfa-2b
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 50 micrograms

1.NAME OF THE MEDICINAL PRODUCT

PegIntron 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 50 micrograms of peginterferon alfa-2b and

provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3.LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. One ampoule of solvent contains 0.7 ml of water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder, 1 ampoule of solvent

1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent

4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs

6 vials of powder, 6 ampoules of solvent

12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs

50 micrograms/0.5 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After withdrawal of the dose, any remaining solution must be discarded.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent)

EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)

EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent)

EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)

EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent)

EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

PegIntron 50 mcg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron 50 micrograms – vial of powder

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

PegIntron 50 micrograms powder for injection peginterferon alfa-2b

SC

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mcg/0.5 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 80 micrograms

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 80 micrograms of peginterferon alfa-2b and

provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. One ampoule of solvent contains 0.7 ml of water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder, 1 ampoule of solvent

1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent

4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs

6 vials of powder, 6 ampoules of solvent

12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs

80 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After withdrawal of the dose, any remaining solution must be discarded.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent)

EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)

EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent)

EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)

EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent)

EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 80 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron 80 micrograms - vial of powder

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

PegIntron 80 micrograms powder for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

80 mcg/0.5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 100 micrograms

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 100 micrograms of peginterferon alfa-2b and

provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. One ampoule of solvent contains 0.7 ml of water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder, 1 ampoule of solvent

1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent

4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs

6 vials of powder, 6 ampoules of solvent

12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs

100 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After withdrawal of the dose, any remaining solution must be discarded.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/011 (1 vial of powder, 1 ampoule of solvent)

EU/1/00/131/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)

EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent)

EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)

EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent)

EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 100 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron 100 micrograms - vial of powder

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

PegIntron 100 micrograms powder for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mcg/0.5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 120 micrograms

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 120 micrograms of peginterferon alfa-2b and

provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. One ampoule of solvent contains 0.7 ml of water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder, 1 ampoule of solvent

1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent

4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs

6 vials of powder, 6 ampoules of solvent

12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs

120 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After withdrawal of the dose, any remaining solution must be discarded.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/016 (1 vial of powder, 1 ampoule of solvent)

EU/1/00/131/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)

EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent)

EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)

EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent)

EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 120 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron 120 micrograms - vial of powder

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

PegIntron 120 micrograms powder for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

120 mcg/0.5 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 150 micrograms

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One vial of powder contains 150 micrograms of peginterferon alfa-2b and

provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. One ampoule of solvent contains 0.7 ml of water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial of powder, 1 ampoule of solvent

1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent

4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs

6 vials of powder, 6 ampoules of solvent

12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs

150 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After withdrawal of the dose, any remaining solution must be discarded.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent)

EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)

EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent)

EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs)

EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent)

EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 150 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron 150 micrograms - vial of powder

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

PegIntron 150 micrograms powder for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

150 mcg/0.5 ml

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PegIntron - ampoule of solvent

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

Solvent for PegIntron

Water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.7 ml

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 50 micrograms powder and solvent for solution for injection in pre-filled pen

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. Solvent: water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection in pre-filled pen

1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs

12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 50 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After injection of the dose, discard the pen in an appropriate container.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs)

EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs)

EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 50 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pen label - PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen

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

PegIntron 50 micrograms powder and solvent for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mcg/0.5 ml

6. OTHER

Pen (CLEARCLICK)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 80 micrograms powder and solvent for solution for injection in pre-filled pen

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 80 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. Solvent: water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection in pre-filled pen

1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs

12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 80 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After injection of the dose, discard the pen in an appropriate container.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs)

EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs)

EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 80 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pen label - PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen

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

PegIntron 80 micrograms powder and solvent for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

80 mcg/0.5 ml

6. OTHER

Pen (CLEARCLICK)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 100 micrograms powder and solvent for solution for injection in pre-filled pen

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. Solvent: water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection in pre-filled pen

1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs

12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 100 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After injection of the dose, discard the pen in an appropriate container.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs)

EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs)

EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 100 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pen label - PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen

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

PegIntron 100 micrograms powder and solvent for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mcg/0.5 ml

6. OTHER

Pen (CLEARCLICK)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 120 micrograms powder and solvent for solution for injection in pre-filled pen

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. Solvent: water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection in pre-filled pen

1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs

12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 120 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After injection of the dose, discard the pen in an appropriate container.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs)

EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs)

EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 120 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pen label - PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen

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

PegIntron 120 micrograms powder and solvent for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

120 mcg/0.5 ml

6. OTHER

Pen (CLEARCLICK)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton 150 micrograms powder and solvent for solution for injection in pre-filled pen

1. NAME OF THE MEDICINAL PRODUCT

PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.

3. LIST OF EXCIPIENTS

Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80. Solvent: water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection in pre-filled pen

1 pen (CLEARCLICK), 1 injection needle and 2 cleansing swabs 4 pens (CLEARCLICK), 4 injection needles and 8 cleansing swabs

12 pens (CLEARCLICK), 12 injection needles and 24 cleansing swabs 150 micrograms/0.5 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).

9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

After injection of the dose, discard the pen in an appropriate container.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs)

EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs)

EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PegIntron 150 mcg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pen label - PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen

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

PegIntron 150 micrograms powder and solvent for injection peginterferon alfa-2b

SC

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

150 mcg/0.5 ml

6. OTHER

Pen (CLEARCLICK)

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