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Vihuma (simoctocog alfa) – Labelling - B02BD02

Updated on site: 10-Oct-2017

Medication nameVihuma
ATC CodeB02BD02
Substancesimoctocog alfa
ManufacturerOctapharma AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Vihuma 250 International Units

Powder and solvent for solution for injection

simoctocog alfa (recombinant human coagulation factor VIII)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

250 International Units/vial simoctocog alfa (100 IU/ml after reconstitution)

3.LIST OF EXCIPIENTS

Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188

Solvent: Water for injections

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Powder vial contains 250 International Units simoctocog alfa.

1 Pre-filled syringe contains 2.5 ml water for injections.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after reconstitution.

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 in a refrigerator. Do not freeze. Store in the original package in order to protect from light. Can be stored at room temperature (up to 25°C) for a single period up to 1 month.

Taken out of 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

Octapharma AB

Lars Forssells gata 23 112 75 Stockholm Sweden

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1168/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

VIHUMA 250

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL WITH POWDER FOR SOLUTION FOR INJECTION

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

Vihuma 250 International Units, powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII). For intravenous use after reconstitution.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

250 IU/vial

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vihuma 500 International Units

Powder and solvent for solution for injection

simoctocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

500 International Units/vial simoctocog alfa (200 IU/ml after reconstitution)

3. LIST OF EXCIPIENTS

Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188

Solvent: Water for injections

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Powder vial contains 500 International Units simoctocog alfa.

1 Pre-filled syringe contains 2.5 ml water for injections.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after reconstitution.

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 in a refrigerator. Do not freeze. Store in the original package in order to protect from light. Can be stored at room temperature (up to 25°C) for a single period up to 1 month.

Taken out of 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

Octapharma AB

Lars Forssells gata 23 112 75 Stockholm Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1168/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VIHUMA 500

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL WITH POWDER FOR SOLUTION FOR INJECTION

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

Vihuma 500 International Units, powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII). For intravenous use after reconstitution.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 IU/vial

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vihuma 1000 International Units

Powder and solvent for solution for injection

simoctocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1000 International Units/vial simoctocog alfa (400 IU/ml after reconstitution)

3. LIST OF EXCIPIENTS

Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188

Solvent: Water for injections

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Powder vial contains 1000 International Units simoctocog alfa.

1 Pre-filled syringe contains 2.5 ml water for injections.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after reconstitution.

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 in a refrigerator. Do not freeze. Store in the original package in order to protect from light. Can be stored at room temperature (up to 25°C) for a single period up to 1 month.

Taken out of 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

Octapharma AB

Lars Forssells gata 23 112 75 Stockholm Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1168/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VIHUMA 1000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL WITH POWDER FOR SOLUTION FOR INJECTION

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

Vihuma 1000 International Units, powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).

For intravenous use after reconstitution.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1000 IU/vial

6. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vihuma 2000 International Units

Powder and solvent for solution for injection

simoctocog alfa (recombinant human coagulation factor VIII)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

2000 International Units/vial simoctocog alfa (800 IU/ml after reconstitution)

3. LIST OF EXCIPIENTS

Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188

Solvent: Water for injections

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Powder vial contains 2000 International Units simoctocog alfa.

1 Pre-filled syringe contains 2.5 ml water for injections.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after reconstitution.

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 in a refrigerator. Do not freeze. Store in the original package in order to protect from light. Can be stored at room temperature (up to 25°C) for a single period up to 1 month.

Taken out of 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

Octapharma AB

Lars Forssells gata 23 112 75 Stockholm Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1168/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

VIHUMA 2000

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL WITH POWDER FOR SOLUTION FOR INJECTION

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

Vihuma 2000 International Units, powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).

For intravenous use after reconstitution.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2000 IU/vial

6. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

PRE-FILLED SYRINGE WITH 2.5 ML WATER FOR INJECTIONS

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

Solvent for Vihuma

Water for injections

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.5 ml

6. OTHER

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