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Zalmoxis (Allogeneic T cells genetically modified...) – Labelling - L01

Updated on site: 11-Oct-2017

Medication nameZalmoxis
ATC CodeL01
SubstanceAllogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
ManufacturerMolMed SpA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER BOX

1.NAME OF THE MEDICINAL PRODUCT

Zalmoxis 5-20 x 106 cells/mL dispersion for infusion

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL

3.LIST OF EXCIPIENTS

Human serum albumine, dimethyl sulphoxide, sodium chloride.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Dispersion for infusion

Bag volume:___________mL

Dose: 1x107 cells /kg

Concentration: _____x10x cells/mL

Total cell number: _____x10X

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

Patient specific product not to be administered to other patients

8.EXPIRY DATE

EXP:

Shelf life after thawing: 2 hours at room temperature (15 °C – 30 °C)

9.SPECIAL STORAGE CONDITIONS

Store in liquid nitrogen vapour.

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

This medicinal product contains genetically-modified cells. Local biosafety guidelines applicable for such products should be followed for unused medicinal product or waste material.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MolMed S.p.A.

Via Olgettina 58

20132 Milano

Italy

12.MARKETING AUTHORISATION NUMBER

EU/1/16/1121/001

13.BATCH NUMBER, DONATION AND PRODUCT CODES

Batch:

Patient code:

Donor code:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

17.UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

PLASTIC BAG

1. NAME OF THE MEDICINAL PRODUCT

Zalmoxis 5-20 x 106 cells/mL dispersion for infusion

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and herpes simplex I virus thymidine kinase (HSV-TK Mut2)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

The bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL

3. LIST OF EXCIPIENTS

Human serum albumine, dimethyl sulphoxide, sodium chloride.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Dispersion for infusion

Bag volume:___________mL

Dose: 1x107 cells /kg

Concentration: _____x10x cells/mL

Total cell number: _____x10X

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

Patient specific product not to be administered to other patients

8. EXPIRY DATE

EXP:

Shelf life after thawing: 2 hours at room temperature (15 °C – 30 °C)

9. SPECIAL STORAGE CONDITIONS

Store in liquid nitrogen vapour.

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

This medicinal product contains genetically-modified cells. Local biosafety guidelines applicable for such products should be followed for unused medicinal product or waste material.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MolMed S.p.A.

Via Olgettina 58

20132 Milano

Italy

12. MARKETING AUTHORISATION NUMBER

EU/1/16/1121/001

13. BATCH NUMBER, DONATION AND PRODUCT CODES

Batch:

Patient code:

Donor code:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

Not applicable

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BAG

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

Zalmoxis 5-20x106 cells/mL dispersion for infusion

Intravenous use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

Expiry date:

Shelf life after thawing: 2 hours

4.BATCH NUMBER, DONATION AND PRODUCT CODES

Batch:

Patient code:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Total cell number: ____x10X

6.OTHER

MolMed SpA

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