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Ultibro Breezhaler (indacaterol / glycopyrronium bromide) – Labelling - R03AL04

Updated on site: 10-Oct-2017

Medication nameUltibro Breezhaler
ATC CodeR03AL04
Substanceindacaterol / glycopyrronium bromide
ManufacturerNovartis Europharm Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium. The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.

3.LIST OF EXCIPIENTS

Also contains: lactose and magnesium stearate.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder, hard capsule

6 x 1 capsules + 1 inhaler

10 x 1 capsules + 1 inhaler

12 x 1 capsules + 1 inhaler

30 x 1 capsules + 1 inhaler

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For use only with the inhaler provided in the pack.

Do not swallow capsules.

Read the package leaflet before use.

Inhalation 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

Each inhaler should be disposed of after 30 days of use.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/862/001

6 capsules + 1 inhaler

 

 

 

EU/1/13/862/007

 

10 capsules + 1 inhaler

 

 

EU/1/13/862/002

 

12 capsules + 1 inhaler

 

 

EU/1/13/862/003

 

30 capsules + 1 inhaler

 

 

 

 

 

13. BATCH NUMBER

 

 

 

Lot

 

 

 

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ultibro Breezhaler

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 CARTON OF MULTIPACK (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium. The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.

3. LIST OF EXCIPIENTS

Also contains: lactose and magnesium stearate.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder, hard capsule

Multipack: 90 (3 packs of 30 x 1) capsules + 3 inhalers.

Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.

Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.

Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For use only with the inhaler provided in the pack.

Do not swallow capsules.

Read the package leaflet before use.

Inhalation 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

Each inhaler should be disposed of after 30 days of use.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/862/004

Multipack comprising 3 packs (30 capsules + 1 inhaler)

 

 

 

EU/1/13/862/005

 

Multipack comprising 4 packs (24 capsules + 1 inhaler)

 

 

 

EU/1/13/862/008

 

Multipack comprising 15 packs (10 capsules + 1 inhaler)

 

 

EU/1/13/862/006

 

Multipack comprising 25 packs (6 capsules + 1 inhaler)

 

 

 

 

 

13. BATCH NUMBER

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ultibro Breezhaler

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 OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium. The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.

3. LIST OF EXCIPIENTS

Also contains: lactose and magnesium stearate.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder, hard capsule

30 x 1 capsules + 1 inhaler. Component of a multipack. Not to be sold separately. 24 x 1 capsules + 1 inhaler. Component of a multipack. Not to be sold separately. 10 x 1 capsules + 1 inhaler. Component of a multipack. Not to be sold separately. 6 x 1 capsules + 1 inhaler. Component of a multipack. Not to be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For use only with the inhaler provided in the pack.

Do not swallow capsules.

Read the package leaflet before use.

Inhalation 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

Each inhaler should be disposed of after 30 days of use.

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.

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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/862/004

Multipack comprising 3 packs (30 capsules + 1 inhaler)

 

 

 

EU/1/13/862/005

 

Multipack comprising 4 packs (24 capsules + 1 inhaler)

 

 

 

EU/1/13/862/008

 

Multipack comprising 15 packs (10 capsules + 1 inhaler)

 

 

EU/1/13/862/006

 

Multipack comprising 25 packs (6 capsules + 1 inhaler)

 

 

 

 

 

13. BATCH NUMBER

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ultibro Breezhaler

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK

1.OTHER

Do not push capsule through foil.

(1) Tear along perforations, (2) then peel back foil and (3) remove capsule. Do not swallow capsules.

Read the leaflet before use.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Ultibro Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Inhalation use only

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