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Rapamune (sirolimus) – Labelling - L04AA10

Updated on site: 09-Oct-2017

Medication nameRapamune
ATC CodeL04AA10
Substancesirolimus
ManufacturerPfizer Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

TEXT FOR 60 mL OUTER CARTON (CONTAINING SYRINGES/BOTTLE IN CARTON)

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 1 mg/mL oral solution sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of Rapamune contains 1 mg sirolimus.

Each 60 mL bottle of Rapamune contains 60 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: ethanol, soya fatty acids. See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Oral solution

1 bottle

30 dosing syringes

1 syringe adapter

1 carrying case

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Store in the original bottle in order to protect from light.

Use within 30 days after opening bottle.

Use within 24 hours after filling the dosing syringe.

After dilution, the preparation should be used immediately.

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Rapamune 1 mg/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 AND THE IMMEDIATE PACKAGING

INTERMEDIATE CARTON: 60 mL BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 1 mg/mL oral solution sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of Rapamune contains 1 mg sirolimus.

Each 60 mL bottle of Rapamune contains 60 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: ethanol, soya fatty acids. See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Oral solution 60 mL bottle

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Store in the original bottle in order to protect from light.

Use within 30 days after opening bottle.

Use within 24 hours after filling the dosing syringe.

After dilution, the preparation should be used immediately.

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL: 60 mL BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 1 mg/mL oral solution sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each mL of Rapamune contains 1 mg sirolimus.

Each 60 mL bottle of Rapamune contains 60 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: ethanol, soya fatty acids. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

60 mL oral solution.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

Date opened

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator. Store in the original bottle in order to protect from light.

Use within 30 days after opening bottle.

Use within 24 hours after filling the dosing syringe.

After dilution, the preparation should be used immediately.

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/001

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTONS – PACK SIZES 30 AND 100 TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 0.5 mg coated tablets sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 0.5 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: lactose monohydrate, sucrose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 coated tablets

100 coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Do not crush, chew or split.

Oral 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

9.SPECIAL STORAGE CONDITIONS

Do not store above 25ºC.

Keep the blister 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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/013 30 tablets

EU/1/01/171/014 100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Rapamune 0.5 mg

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 BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 0.5 mg tablets sirolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTONS – PACK SIZES 30 AND 100 TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 1 mg coated tablets sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 1 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: lactose monohydrate, sucrose. See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

30 coated tablets

100 coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Do not crush, chew or split

Oral 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

9.SPECIAL STORAGE CONDITIONS

Do not store above 25˚C.

Keep the blister 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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/007 30 tablets

EU/1/01/171/008 100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Rapamune 1 mg

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 BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 1 mg tablets sirolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTONS – PACK SIZES 30 AND 100 TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 2 mg coated tablets sirolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each coated tablet contains 2 mg sirolimus.

3.LIST OF EXCIPIENTS

Also contains: lactose monohydrate, sucrose. See package leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

30 coated tablets

100 coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Do not crush, chew or split

Oral 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

9.SPECIAL STORAGE CONDITIONS

Do not store above 25˚C.

Keep the blister 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

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/171/009 30 tablets

EU/1/01/171/010 100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Rapamune 2 mg

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 BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Rapamune 2 mg tablets sirolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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