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
- 1. Open pouch. Do not open pouch until ready to use.
- 2. Pull tab.
- 3. Exhale.
- 4. Inhale.
- 5. Hold Breath.
- 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
CARTON
1.NAME OF THE MEDICINAL PRODUCT
ADASUVE 4.5 mg inhalation powder,
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each inhaler delivers 4.5 mg loxapine.
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder,
1 single dose inhaler
5
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
Inhalation use
For single use only
This product is packaged in a sealed pouch and should remain in the pouch until ready to 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

9.SPECIAL STORAGE CONDITIONS
Store in the original pouch until ready for use in order to protect from light and moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028- Barcelona
España
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/13/823/001 (5
EU/1/13/823/003 (1
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
POUCH
1. NAME OF THE MEDICINAL PRODUCT
ADASUVE 4.5 mg inhalation powder loxapine
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each inhaler delivers 4.5 mg loxapine.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder
One
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Directions for use inside
Read the package leaflet before use
Do not open pouch until ready to use
Inhalation use
Directions for use
Read the following 5 steps before administering ADASUVE to a patient:
1. Open pouch. Do not open pouch until ready to use.
Tear open the foil pouch and remove the inhaler from the package.

2. Pull tab.
Firmly pull the plastic tab from the rear of the inhaler. The green light turns on indicating that the inhaler is ready for use.
Use within 15 minutes after removing the tab (or until the green light turns off) to prevent automatic deactivation of the inhaler.
Instruct the patient to:
3. Exhale.
Hold the inhaler away from the mouth and breathe out fully to empty lungs.
4. Inhale.
Inhale through the mouthpiece with a steady, deep breath.
IMPORTANT: Check that the green light turns off after the patient inhales.
5. Hold Breath.
Remove the mouthpiece from the mouth and hold breath briefly.
Note: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3 to 5.

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
Do not use in patients with asthma or COPD or acute respiratory symptoms
A
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original pouch until ready for use in order to protect from light and moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028- Barcelona
España
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/823/001 (5
EU/1/13/823/003 (1
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
DEVICE HOUSING
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ADASUVE 4.5 mg inhalation powder loxapine
2.METHOD OF ADMINISTRATION
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
4.5 mg
- Tandemact
- Repso
- Leflunomide teva
- Clopidogrel krka d.d. (zopya)
- Stalevo
- Tepadina
Prescription drugs listed:
6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
ADASUVE 9.1 mg inhalation powder,
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each inhaler delivers 9.1 mg loxapine.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder,
1 single dose inhaler
5
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
Inhalation use
For single use only
This product is packaged in a sealed pouch and should remain in the pouch until ready to 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

9. SPECIAL STORAGE CONDITIONS
Store in the original pouch until ready for use in order to protect from light and moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028- Barcelona
España
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/823/002 (5
EU/1/13/823/004 (1
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
POUCH
1. NAME OF THE MEDICINAL PRODUCT
ADASUVE 9.1 mg inhalation powder loxapine
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each inhaler delivers 9.1 mg loxapine.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder
One
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Directions for use inside
Read the package leaflet before use
Do not open pouch until ready to use
Inhalation use
Directions for use
Read the following 5 steps before administering ADASUVE to a patient:
1. Open pouch. Do not open pouch until ready to use.
Tear open the foil pouch and remove the inhaler from the package.

2. Pull tab. Firmly pull the plastic tab from the rear of the inhaler. The green light turns on indicating that the inhaler is ready for use.
Use within 15 minutes after removing the tab (or until the green light turns off) to prevent automatic deactivation of the inhaler.
Instruct the patient to:
3. Exhale. Hold the inhaler away from the mouth and breathe out fully to empty lungs.
4. Inhale. Inhale through the mouthpiece with a steady, deep breath.
IMPORTANT: Check that the green light turns off after the patient inhales.
5. Hold Breath. Remove the mouthpiece from the mouth and hold breath briefly.
Note: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3 to 5.

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
Do not use in patients with asthma or COPD or acute respiratory symptoms
A
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original pouch until ready for use in order to protect from light and moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028- Barcelona
España
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/823/002 (5
EU/1/13/823/004 (1
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
DEVICE HOUSING
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ADASUVE 9.1 mg inhalation powder loxapine
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
9.1 mg
6. OTHER
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