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Quinsair (levofloxacin) – Labelling - J01MA12

Updated on site: 09-Oct-2017

Medication nameQuinsair
ATC CodeJ01MA12
Substancelevofloxacin
ManufacturerHorizon Pharma Europe BV

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON BOX CONTAINING INNER CARTON BOX CONTAINING

56 (14 SACHETS OF 4) AMPOULES PLUS ONE “ZIRELA” NEBULISER HANDSET

1.NAME OF THE MEDICINAL PRODUCT

Quinsair 240 mg nebuliser solution

Levofloxacin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. Each ampoule contains 240 mg of levofloxacin,

3.LIST OF EXCIPIENTS

magnesium chloride hexahydrate and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Nebuliser solution

56 (14 sachets of 4) ampoules

This pack also contains one Zirela Nebuliser Handset.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only. Once opened, use immediately.

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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light.

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

Horizon Pharma Europe B.V.

Naritaweg 165

1043 BW Amsterdam

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/973/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Quinsair

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES

1. NAME OF THE MEDICINAL PRODUCT

Quinsair 240 mg nebuliser solution

Levofloxacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. Each ampoule contains 240 mg of levofloxacin,

3. LIST OF EXCIPIENTS

magnesium chloride hexahydrate and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Nebuliser solution

56 (14 sachets of 4) ampoules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only. Once opened, use immediately.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light.

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

Horizon Pharma Europe B.V.

Naritaweg 165

1043 BW Amsterdam

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/973/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Quinsair

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

FOIL LAMINATE SACHET CONTAINING 4 AMPOULES

1. NAME OF THE MEDICINAL PRODUCT

Quinsair 240 mg nebuliser solution

Levofloxacin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin. Each ampoule contains 240 mg of levofloxacin,

3. LIST OF EXCIPIENTS

magnesium chloride hexahydrate and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Nebuliser solution

4 ampoules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For single use only. Once opened, use immediately.

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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light.

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

Horizon Pharma Europe B.V.

Naritaweg 165

1043 BW Amsterdam

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/973/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LOW DENSITY POLYETHYLENE AMPOULE

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

Quinsair 240 mg nebuliser solution

Levofloxacin

Inhalation use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

2.4 ml

6.OTHER

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