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Caelyx (doxorubicin hydrochloride) – Labelling - L01DB

Updated on site: 05-Oct-2017

Medication nameCaelyx
ATC CodeL01DB
Substancedoxorubicin hydrochloride
ManufacturerJanssen-Cilag International N.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CAELYX CARTON 20 mg/10 ml – 1 vial

CAELYX CARTON 20 mg/10 ml – 10 vials

1.NAME OF THE MEDICINAL PRODUCT

Caelyx 2 mg/ml concentrate for solution for infusion

Pegylated liposomal doxorubicin hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.

3.LIST OF EXCIPIENTS

Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- - methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.

4.PHARMACEUTICAL FORM AND CONTENTS

1 vial

10 vials

20 mg/10 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion. 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

DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

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

Partially used vials should be discarded.

Cytotoxic

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/96/011/001 (1 vial)

EU/1/96/011/002 (10 vials)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Caelyx 20 mg/10 ml

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

CAELYX CARTON 50 mg/25 ml – 1 vial

CAELYX CARTON 50 mg/25 ml – 10 vials

1. NAME OF THE MEDICINAL PRODUCT

Caelyx 2 mg/ml concentrate for solution for infusion

Pegylated liposomal doxorubicin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.

3. LIST OF EXCIPIENTS

Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)- - methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.

4. PHARMACEUTICAL FORM AND CONTENTS

1 vial

10 vials

50 mg/25 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion. 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

DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Do not freeze.

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

Partially used vials should be discarded.

Cytotoxic

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/96/011/003 (1 vial)

EU/1/96/011/004 (10 vials)

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Caelyx 50 mg/25 ml

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CAELYX LABEL 20 mg/10 ml

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

Caelyx 2 mg/ml concentrate for solution for infusion

Pegylated liposomal doxorubicin hydrochloride

Intravenous use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

20 mg/10 ml

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CAELYX LABEL 50 mg/25 ml

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

Caelyx 2 mg/ml concentrate for solution for infusion

Pegylated liposomal doxorubicin hydrochloride

Intravenous use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

50 mg/25 ml

6. OTHER

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