English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Aerivio Spiromax (salmeterol xinafoate / fluticasone propionate) – Labelling - R03AK06

Updated on site: 05-Oct-2017

Medication nameAerivio Spiromax
ATC CodeR03AK06
Substancesalmeterol xinafoate / fluticasone propionate
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.

Each delivered dose (the dose from the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder

1 inhaler containing 60 doses.

3 inhalers each containing 60 doses.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet carefully 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

Use as directed by your doctor.

Front panel: Not for use in children and adolescents.

Side panel: For use in adults 18 years of age and older only.

Not for use in children or adolescents under 18 years of age.

8.EXPIRY DATE

EXP

Use within 3 months of removing from foil wrapping.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C. Keep the mouthpiece cover closed after the removal of foil wrap.

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

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1122/001

EU/1/16/1122/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Aerivio Spiromax 50 mcg/500 mcg

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

FOIL

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

Aerivio Spiromax 50 micrograms/500 micrograms inhalation powder

salmeterol /fluticasone propionate

Inhalation use

2.METHOD OF ADMINISTRATION

Read the package leaflet

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 1 inhaler

6.OTHER

Keep the mouthpiece cover closed and use within 3 months of removing from foil wrapping.

Teva B.V.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

INHALER

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

Aerivio Spiromax 50 micrograms/500 micrograms

Inhalation powder

salmeterol/fluticasone propionate

Inhalation use

2. METHOD OF ADMINISTRATION Read the package leaflet carefully before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

60 doses

6. OTHER

Adults only.

Contains lactose.

Start:

Teva B.V.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed