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Kiovig (human normal immunoglobulin (IVIg)) – Labelling - J06BA02

Updated on site: 08-Oct-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON (1G, 2.5G, 5G, 10G, 20G AND 30G)

1.NAME OF THE MEDICINAL PRODUCT

KIOVIG 100 mg/ml solution for infusion

Human normal immunoglobulin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Human protein, 100 mg/ml, at least 98% is IgG.

Maximum immunoglobulin A (IgA) content: 140 micrograms/ml. 1 g / 10 ml

2.5 g / 25 ml

5 g / 50 ml

10 g / 100 ml

20 g / 200 ml

30 g / 300 ml

3.LIST OF EXCIPIENTS

Glycine

Water for injections

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion (10%) 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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

Do not store above 25°C.

Do not freeze.

Keep the container 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

Baxter AG

Industriestrasse 67

A-1221 Vienna

Austria

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/05/329/001 1 g / 10 ml

EU/1/05/329/002 2.5 g / 25 ml

EU/1/05/329/003 5 g / 50 ml

EU/1/05/329/004 10 g / 100 ml

EU/1/05/329/005 20 g / 200 ml

EU/1/05/329/006 30 g / 300 ml

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

KIOVIG

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

National unique code included.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL (5G, 10G, 20G AND 30G)

1. NAME OF THE MEDICINAL PRODUCT

KIOVIG 100 mg/ml solution for infusion

Human normal immunoglobulin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Human protein, 100 mg/ml, at least 98% is IgG.

Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.

5 g / 50 ml

10 g / 100 ml

20 g / 200 ml

30 g / 300 ml

3. LIST OF EXCIPIENTS

Glycine

Water for injections

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for infusion (10%) 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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

Do not store above 25°C.

Do not freeze.

Keep the container 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

Baxter AG

Industriestrasse 67

A-1221 Vienna

Austria

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/05/329/003 5 g / 50 ml

EU/1/05/329/004 10 g / 100 ml

EU/1/05/329/005 20 g / 200 ml

EU/1/05/329/006 30 g / 300 ml

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

National unique code included.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL (1G)

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

KIOVIG 100 mg/ml solution for infusion

Human Normal Immunoglobulin

Intravenous use.

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

1 g / 10 ml

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL (2.5G)

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

KIOVIG 100 mg/ml solution for infusion

Human Normal Immunoglobulin

Intravenous use.

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

2.5 g / 25 ml

6. OTHER

Do not store above 25°C.

Do not freeze.

Keep the container in the outer carton in order to protect from light.

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