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
DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder
budesonide / formoterol fumarate dihydrate
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
3.LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information
4.PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder
1 inhaler containing 120 doses.
2 inhalers each containing 120 doses.
3 inhalers each containing 120 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
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 the product within 6 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 Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/14/920/001
EU/1/14/920/002
EU/1/14/920/003
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
- Vylaer spiromax - budesonide / formoterol fumarate dihydrate
- Biresp spiromax - budesonide / formoterol fumarate dihydrate
Prescription drugs listed. Substance: "Budesonide / formoterol fumarate dihydrate"
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
DuoResp Spiromax 160 mcg/4.5 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
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
budesonide/ formoterol fumarate dihydrate
Inhalation use.
2.METHOD OF ADMINISTRATION
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 6 months of removing from foil wrapping.
Teva Pharma B.V.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
INHALER
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
DuoResp Spiromax 160 mcg/4.5 mcg inhalation powder
budesonide/formoterol fumarate dihydrate
Inhalation use.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
120 doses
6. OTHER
Start
- Rivastigmine teva - Teva Pharma B.V.
- Biresp spiromax - Teva Pharma B.V.
- Pioglitazone teva pharma - Teva Pharma B.V.
- Mycophenolate mofetil teva - Teva Pharma B.V.
- Leflunomide teva - Teva Pharma B.V.
- Repaglinide teva - Teva Pharma B.V.
Prescription drugs listed. Manufacturer: "Teva Pharma B.V."
Teva Pharma B.V.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
budesonide/formoterol fumarate dihydrate
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information
4. PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder
1 inhaler containing 60 doses.
2 inhalers each 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
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 the product within 6 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 Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/14/920/004
EU/1/14/920/005
EU/1/14/920/006
13. BATCH NUMBER
Lot
- Biresp spiromax - R03AK07
- Vylaer spiromax - R03AK07
Prescription drugs listed. ATC Code: "R03AK07"
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
DuoResp Spiromax 320 mcg/9 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
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
budesonide/formoterol fumarate dihydrate
Inhalation use.
2. METHOD OF ADMINISTRATION
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 6 months of removing from foil wrapping.
Teva Pharma B.V.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
INHALER
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
DuoResp Spiromax 320 mcg/9 mcg inhalation powder
budesonide/formoterol fumarate dihydrate
Inhalation use.
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
60 doses
6. OTHER
Start
Teva Pharma B.V.
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