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Potactasol (topotecan) – Labelling - L01XX17

Updated on site: 09-Oct-2017

Medication namePotactasol
ATC CodeL01XX17
Substancetopotecan
ManufacturerActavis Group PTC ehf

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1.NAME OF THE MEDICINAL PRODUCT

Potactasol 1 mg powder for concentrate for solution for infusion topotecan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 1 mg topotecan (as hydrochloride).

After reconstitution, 1 ml concentrate contains 1 mg topotecan.

3.LIST OF EXCIPIENTS

Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion. 1 x 1 mg vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use as infusion, after reconstitution and dilution.

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

Cytotoxic, special handling instructions (see package leaflet).

Cytotoxic

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

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

Any unused product or waste material should be disposed of in accordance with local requirements.

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/660/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Potactasol 1 mg powder for concentrate for solution for infusion topotecan

IV

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 mg

6.OTHER

Cytotoxic

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton

1. NAME OF THE MEDICINAL PRODUCT

Potactasol 4 mg powder for concentrate for solution for infusion topotecan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains 4 mg topotecan (as hydrochloride).

After reconstitution, 1 ml concentrate contains 1 mg topotecan.

3. LIST OF EXCIPIENTS

Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion. 1 x 4 mg vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For intravenous use as infusion, after reconstitution and dilution.

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

Cytotoxic, special handling instructions (see package leaflet).

Cytotoxic

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Any unused product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/10/660/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial

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

Potactasol 4 mg powder for concentrate for solution for infusion topotecan

IV

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

4 mg

6. OTHER

Cytotoxic

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