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Zalviso (sufentanil) – Labelling - N01AH03

Updated on site: 11-Oct-2017

Medication nameZalviso
ATC CodeN01AH03
Substancesufentanil
ManufacturerGrunenthal GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON for 1, 10 and 20 cartridges

1.NAME OF THE MEDICINAL PRODUCT

Zalviso 15 micrograms sublingual tablets

Sufentanil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each sublingual tablet contains 15 micrograms sufentanil (as citrate).

3.LIST OF EXCIPIENTS

Contains sunset yellow FCF Aluminium Lake (E110). See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 cartridge of 40 sublingual tablets

10 cartridges of 40 sublingual tablets each

20 cartridges of 40 sublingual tablets each

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Sublingual use.

To be used only with the Zalviso administration device.

Place immediately into the Zalviso administration device after removal from sachet. Do not crush, chew, or swallow the tablet.

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 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

Grünenthal GmbH

Zieglerstr. 6

52078 Aachen

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1042/001 1 cartridge of 40 sublingual tablets

EU/1/15/1042/002 10 cartridges of 40 sublingual tablets each

EU/1/15/1042/003 20 cartridges of 40 sublingual tablets each

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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

INTERMEDIATE CARTON COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Zalviso 15 micrograms sublingual tablets

Sufentanil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sublingual tablet contains 15 micrograms sufentanil (as citrate).

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF Aluminium Lake (E110). See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

800 sublingual tablets (20 cartridges of 40 sublingual tablets each). Component of multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Sublingual use.

To be used only with the Zalviso administration device.

Place immediately into the Zalviso administration device after removal from sachet. Do not crush, chew, or swallow the tablet.

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 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

Grünenthal GmbH

Zieglerstr. 6

52078 Aachen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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

OUTER LABEL (WITH BLUE BOX)

MULTIPACKS ONLY

1. NAME OF THE MEDICINAL PRODUCT

Zalviso 15 micrograms sublingual tablets

Sufentanil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sublingual tablet contains 15 micrograms sufentanil (as citrate).

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF Aluminium Lake (E110). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 1600 sublingual tablets [40 (2 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 2400 sublingual tablets [60 (3 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 4000 sublingual tablets [100 (5 packs of 20) cartridges of 40 sublingual tablets each]

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Sublingual use.

To be used only with the Zalviso administration device.

Place immediately into the Zalviso administration device after removal from sachet. Do not crush, chew, or swallow the tablet.

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 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

Grünenthal GmbH

Zieglerstr. 6

52078 Aachen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1042/004 2 x 20 cartridges of 40 sublingual tablets each

EU/1/15/1042/005 3 x 20 cartridges of 40 sublingual tablets each

EU/1/15/1042/006 5 x 20 cartridges of 40 sublingual tablets each

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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

SACHET

1. NAME OF THE MEDICINAL PRODUCT

Zalviso 15 micrograms sublingual tablets

Sufentanil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sublingual tablet contains 15 micrograms sufentanil (as citrate).

3. LIST OF EXCIPIENTS

Contains sunset yellow FCF Aluminium Lake (E110). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 cartridge of 40 sublingual tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. Sublingual use.

To be used only with the Zalviso administration device.

Place immediately into the Zalviso administration device after removal from sachet. Do not crush, chew, or swallow the tablet.

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

EXP see page 1

EXP see reverse

9. SPECIAL STORAGE CONDITIONS

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

Grünenthal GmbH

Zieglerstr. 6

52078 Aachen

Germany

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

Lot see page 1

Lot see reverse

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

CARTRIDGE

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

Zalviso 15 micrograms sublingual tablets

Sufentanil

Sublingual use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

40 sublingual tablets

6.OTHER

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