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Lartruvo (olaratumab) – Labelling - L01XC27

Updated on site: 08-Oct-2017

Medication nameLartruvo
ATC CodeL01XC27
Substanceolaratumab
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – 50 mL vial

1.NAME OF THE MEDICINAL PRODUCT

Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One mL of concentrate contains 10 mg of olaratumab.

One vial of 50 mL contains 500 mg olaratumab.

3.LIST OF EXCIPIENTS

Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

500 mg/50 mL

1vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after dilution.

For single 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

Do not shake.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vial 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

Eli Lilly Nederland B.V.

Papendorpseweg 83,

3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1143/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – 19 mL vial

1. NAME OF THE MEDICINAL PRODUCT

Lartruvo 10 mg/mL concentrate for solution for infusion olaratumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One mL of concentrate contains 10 mg of olaratumab.

One vial of 19 mL contains 190 mg olaratumab.

3. LIST OF EXCIPIENTS

Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

190 mg/19 mL

1vial

2vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use after dilution.

For single 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

Do not shake.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vial 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

Eli Lilly Nederland B.V.

Papendorpseweg 83,

3528 BJ Utrecht

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1143/002 – 1 vial of 19 mL.

EU/1/16/1143/003 – 2 vials of 19 mL.

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL – 50 mL vial

1. NAME OF THE MEDICINAL PRODUCT

Lartruvo 10 mg/mL sterile concentrate olaratumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One mL of concentrate contains 10 mg of olaratumab.

One vial of 50 mL contains 500 mg olaratumab.

3. LIST OF EXCIPIENTS

Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

500 mg/50 mL

1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For IV use after dilution.

For single 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

Do not shake.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vial in the outer carton.

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

Eli Lilly Nederland B.V.

Papendorpseweg 83,

3528 BJ Utrecht

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1143/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL – 19 mL vial

1. NAME OF THE MEDICINAL PRODUCT

Lartruvo 10 mg/mL sterile concentrate olaratumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One mL of concentrate contains 10 mg of olaratumab.

One vial of 19 mL contains 190 mg olaratumab.

3. LIST OF EXCIPIENTS

Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

190 mg/19 mL

1vial

2vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For IV use after dilution.

For single 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

Do not shake.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the vial in the outer carton.

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

Eli Lilly Nederland B.V.

Papendorpseweg 83,

3528 BJ Utrecht

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1143/002 – 1 vial of 19 mL.

EU/1/16/1143/003 – 2 vials of 19 mL.

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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