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Docetaxel Mylan (docetaxel, anhydrous) – Labelling - L01CD02

Updated on site: 06-Oct-2017

Medication nameDocetaxel Mylan
ATC CodeL01CD02
Substancedocetaxel, anhydrous
ManufacturerMylan S.A.S.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains

20 mg docetaxel (anhydrous).

authorised

One vial of 1 ml of concentrate contains 20 mg of docetaxel.

 

 

3. LIST OF EXCIPIENTS

 

 

Excipients: polysorbate 80, ethanol anhydrous and citric acid. See the le flet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Concentrate for solution for infusion

 

longer

 

1 vial of 1 ml

no

 

5 vials of 1 ml

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet beforeproductuse.

ReadyMedicinalto add to infusion so ution.

Withdraw the required mount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.

Single-use vial.

Intravenous 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

8.EXPIRY DATE

EXP:

Read the leaflet for the shelf life of the diluted medicine.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store in the original package 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.

 

 

 

 

 

authorised

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

 

Mylan S.A.S.

 

 

 

 

 

 

117 allée des parcs

 

 

 

 

 

 

69800 Saint Priest

 

 

 

 

 

 

France

 

 

 

 

 

 

 

 

 

 

 

 

 

12.

 

 

 

 

longer

 

MARKETING AUTHORISATION NUMBER(S)

 

 

EU/1/11/748/001 - 1 vial

 

 

 

 

 

 

EU/1/11/748/002 - 5 vials

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

BATCH NUMBER

 

 

no

 

 

 

Lot:

 

product

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

Medicinal product subject to medical prescription.

 

 

 

 

 

 

 

 

 

 

15.

Medicinal

 

 

 

 

 

INSTRUCTIONS ON USE

 

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

 

 

 

 

Justification for not including Braille accepted

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel

Intravenous use

2.

METHOD OF ADMINISTRATION

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

EXP:

 

 

 

 

 

 

4.

BATCH NUMBER<, DONATION AND PRODUCT CODES>

 

 

 

 

authorised

Lot:

 

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

 

longer

 

20 mg/1 ml

 

no

 

 

 

 

 

6.

OTHER

product

 

 

 

 

 

 

Medicinal

 

 

 

Each ml of concentrate contains 20 mg docetaxel (anhydrous). One vial of 4 ml of concentrate contains 80 mg of docetaxel.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous and citric acid. See the le flet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Concentrate for solution for infusion

 

longer

 

1 vial of 4 ml

no

 

5 vials of 4 ml

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

product

 

 

Read the package leaflet before use.

Ready to add to infusion solution.

Single-use vial.

Intravenous use.

Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directlyMedicinalinto the infusion solution.

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

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP:

Read the leaflet for the shelf life of the diluted medicine.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store in the original package 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

Mylan S.A.S.

117 allée des parcs

69800 Saint Priest France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/748/003 - 1 vial

 

 

 

longer

 

 

 

 

EU/1/11/748/004 - 5 vials

 

 

 

 

13.

BATCH NUMBER

 

 

no

 

Lot:

 

product

 

 

 

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

 

15.

Medicinal

 

 

 

 

INSTRUCTIONS ON USE

 

 

16.

INFORMATION IN BRAILLE

 

 

 

 

 

 

Justification for not including Braille accepted

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

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

Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel

Intravenous use

2.

METHOD OF ADMINISTRATION

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

EXP:

 

 

 

 

 

 

4.

BATCH NUMBER<, DONATION AND PRODUCT CODES>

 

 

 

 

authorised

Lot:

 

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

 

longer

 

80 mg/4 ml

 

no

 

 

 

 

 

6.

OTHER

product

 

 

 

 

 

 

Medicinal

 

 

 

Each ml of concentrate contains 20 mg docetaxel (anhydrous). One vial of 10 ml of concentrate contains 200 mg of docetaxel.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion docetaxel

2. STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

3. LIST OF EXCIPIENTS

Excipients: polysorbate 80, ethanol anhydrous and citric acid. See the le flet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Concentrate for solution for infusion

 

longer

 

1 vial of 10 ml

no

 

5 vials of 10 ml

 

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

 

product

 

 

Read the package leaflet before use.

Ready to add to infusion solution.

Single-use vial.

Intravenous use.

Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directlyMedicinalinto the infusion solution.

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:

Read the leaflet for the shelf life of the diluted medicine.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store in the original package 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

Mylan S.A.S.

117 allée des parcs

69800 Saint Priest France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/748/005 - 1 vial

 

 

longer

EU/1/11/748/006 - 5 vials

 

 

 

 

 

13.

BATCH NUMBER

 

no

 

Lot:

 

product

 

 

 

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

 

15.

INSTRUCTIONS ON USE

 

 

16.

Medicinal

 

 

 

INFORMATION IN BRAILLE

 

 

Justification for not including Braille accepted

authorised

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL / Docetaxel Mylan 200 mg/10 ml

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

Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel

Intravenous use

2.

METHOD OF ADMINISTRATION

 

 

 

 

 

 

 

3.

EXPIRY DATE

 

 

 

EXP:

 

 

 

 

 

 

4.

BATCH NUMBER<, DONATION AND PRODUCT CODES>

 

 

 

 

authorised

Lot:

 

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

 

 

 

longer

 

200 mg/10 ml

 

no

 

 

 

 

 

6.

OTHER

product

 

 

 

 

 

 

Medicinal

 

 

 

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