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Brimica Genuair (aclidinium / formoterol fumarate dihydrate) – Labelling - R03AL05

Updated on site: 05-Oct-2017

Medication nameBrimica Genuair
ATC CodeR03AL05
Substanceaclidinium / formoterol fumarate dihydrate
ManufacturerAstraZeneca AB

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Brimica Genuair 340/12 micrograms inhalation powder

Aclidinium/Formoterol fumarate dihydrate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each delivered dose contains 396 micrograms aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.

3.LIST OF EXCIPIENTS

Also contains: Lactose

See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

1 inhaler containing 30 doses

1 inhaler containing 60 doses

3 inhalers each containing 60 doses

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Inhalation use

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

8.EXPIRY DATE

EXP

To be used within 60 days of opening pouch.

9.SPECIAL STORAGE CONDITIONS

Keep the Genuair inhaler protected inside the sealed pouch until the administration period starts.

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

AstraZeneca AB

SE-151 85 Södertälje

Sweden

AstraZeneca (AstraZeneca logo)

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

EU/1/14/963/001

1 inhaler with 60 doses

 

EU/1/14/963/002

3 inhalers each with 60

doses

 

 

EU/1/14/963/003

1 inhaler with 30 doses

 

 

 

 

13.

BATCH NUMBER

 

Lot

 

 

 

 

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

brimica genuair

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 ALUMINIUM POUCH

1. NAME OF THE MEDICINAL PRODUCT

Brimica Genuair 340/12 micrograms inhalation powder

Aclidinium/Formoterol fumarate dihydrate

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca (AstraZeneca logo)

3.EXPIRY DATE

EXP

To be used within 60 days of opening the pouch.

4.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

5.OTHER

Keep the Genuair inhaler protected inside the sealed pouch until the administration period starts.

[arrow] Tear here

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

INHALER LABEL

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

Brimica Genuair 340/12 mcg inhalation powder

Aclidinium/Formoterol fumarate dihydrate

2.METHOD OF ADMINISTRATION

Inhalation use

3. EXPIRY DATE

To be used within 60 days of opening the pouch.

EXP

4. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 doses

60 doses

6.OTHER

AstraZeneca (AstraZeneca logo)

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