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Zutectra (human hepatitis-B immunoglobulin) – Labelling - J06BB04

Updated on site: 11-Oct-2017

Medication nameZutectra
ATC CodeJ06BB04
Substancehuman hepatitis-B immunoglobulin
ManufacturerBiotest Pharma GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER BOX

1.NAME OF THE MEDICINAL PRODUCT

Zutectra 500 IU solution for injection in pre-filled syringe

Human hepatitis B immunoglobulin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

1 ml contains:

Human protein 150 mg of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU.

IgG subclass distribution:

59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA content 6,000 micrograms/ml

3.LIST OF EXCIPIENTS

Excipients: Glycine, water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection 5 pre-filled syringes

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For subcutaneous use only.

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

The solution should be administered immediately after opening the syringe.

9.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated (2°C-8°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

Biotest Pharma GmbH

Landsteinerstr. 5

D-63303 Dreieich

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/600/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zutectra 500 IU

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Zutectra 500 IU injection

Human hepatitis B immunoglobulin

Subcutaneous use

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Biotest Pharma GmbH

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SYRINGE

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

Zutectra 500 IU injection

Human hepatitis B immunoglobulin

Subcutaneous use

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

500 IU

6.OTHER

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