Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE CONDITIONS
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 17. UNIQUE IDENTIFIER – 2D BARCODE
- 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
- 2. METHOD OF ADMINISTRATION
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
- 6. OTHER
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
- Airexar spiromax - R03AK06
Prescription drugs listed. ATC Code: "R03AK06"
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
