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Mycamine (micafungin) – Labelling - J02AX05

Updated on site: 08-Oct-2017

Medication nameMycamine
ATC CodeJ02AX05
Substancemicafungin
ManufacturerAstellas Pharma Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Mycamine 50 mg powder for solution for infusion

Micafungin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains: 50 mg micafungin (as sodium).

After reconstitution each ml contains 10 mg of micafungin (as sodium).

3.LIST OF EXCIPIENTS

Lactose monohydrate, citric acid anhydrous and sodium hydroxide.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion 1 vial

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT 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

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/448/001

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

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

Mycamine 50 mg powder for solution for infusion

Micafungin

Intravenous use.

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Mycamine 100 mg powder for solution for infusion

Micafungin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains: 100 mg micafungin (as sodium).

After reconstitution each ml contains 20 mg of micafungin (as sodium).

3. LIST OF EXCIPIENTS

Lactose monohydrate, citric acid anhydrous and sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for solution for infusion 1 vial

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intravenous use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT 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

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

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/448/002

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

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

Mycamine 100 mg powder for solution for infusion

Micafungin

Intravenous use.

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

100 mg

6. OTHER

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