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Aerius (desloratadine) – Labelling - R06AX27

Updated on site: 11-Jul-2017

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Aerius 5 mg film-coated tablets desloratadine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg desloratadine.

3.LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet

2 film-coated tablets

3 film-coated tablets

5 film-coated tablets

7 film-coated tablets

10 film-coated tablets

14 film-coated tablets

15 film-coated tablets

20 film-coated tablets

21 film-coated tablets

30 film-coated tablets

50 film-coated tablets

90 film-coated tablets

100 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablet whole with water.

Oral 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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C. Store in the original package.

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/00/160/001 1 tablet

EU/1/00/160/002 2 tablets

EU/1/00/160/003 3 tablets

EU/1/00/160/004 5 tablets

EU/1/00/160/005 7 tablets

EU/1/00/160/006 10 tablets

EU/1/00/160/007 14 tablets

EU/1/00/160/008 15 tablets

EU/1/00/160/009 20 tablets

EU/1/00/160/010 21 tablets

EU/1/00/160/011 30 tablets

EU/1/00/160/012 50 tablets

EU/1/00/160/036 90 tablets

EU/1/00/160/013 100 tablets

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Aerius

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Aerius 5 mg tablet desloratadine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Aerius 2.5 mg orodispersible tablets desloratadine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose of orodispersible tablet contains 2.5 mg desloratadine.

3. LIST OF EXCIPIENTS

Contains mannitol and aspartame.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 orodispersible tablets

6 orodispersible tablets

10 orodispersible tablets

12 orodispersible tablets

15 orodispersible tablets

18 orodispersible tablets

20 orodispersible tablets

30 orodispersible tablets

50 orodispersible tablets

60 orodispersible tablets

90 orodispersible tablets

100 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package.

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/160/037

5 orodispersible tablets

 

 

EU/1/00/160/038

6 orodispersible tablets

 

 

EU/1/00/160/039

10 orodispersible tablets

 

 

EU/1/00/160/040

12 orodispersible tablets

 

EU/1/00/160/041

15 orodispersible tablets

 

EU/1/00/160/042

18 orodispersible tablets

 

EU/1/00/160/043

20 orodispersible tablets

 

EU/1/00/160/044

30 orodispersible tablets

 

EU/1/00/160/045

50 orodispersible tablets

 

EU/1/00/160/046

60 orodispersible tablets

 

EU/1/00/160/047

90 orodispersible tablets

 

EU/1/00/160/048

100 orodispersible tablets

 

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aerius 2.5 mg orodispersible tablet

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Aerius 2.5 mg orodispersible tablets desloratadine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Aerius 5 mg orodispersible tablets desloratadine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose of orodispersible tablet contains 5 mg desloratadine.

3. LIST OF EXCIPIENTS

Contains mannitol and aspartame.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

5 orodispersible tablets

6 orodispersible tablets

10 orodispersible tablets

12 orodispersible tablets

15 orodispersible tablets

18 orodispersible tablets

20 orodispersible tablets

30 orodispersible tablets

50 orodispersible tablets

60 orodispersible tablets

90 orodispersible tablets

100 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package.

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/160/049

5 orodispersible tablets

 

 

EU/1/00/160/050

6 orodispersible tablets

 

 

EU/1/00/160/051

10 orodispersible tablets

 

 

EU/1/00/160/052

12 orodispersible tablets

 

EU/1/00/160/053

15 orodispersible tablets

 

EU/1/00/160/054

18 orodispersible tablets

 

EU/1/00/160/055

20 orodispersible tablets

 

EU/1/00/160/056

30 orodispersible tablets

 

EU/1/00/160/057

50 orodispersible tablets

 

EU/1/00/160/058

60 orodispersible tablets

 

EU/1/00/160/059

90 orodispersible tablets

 

EU/1/00/160/060

100 orodispersible tablets

 

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aerius 5 mg orodispersible tablet

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Aerius 5 mg orodispersible tablets desloratadine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML

1. NAME OF THE MEDICINAL PRODUCT

Aerius 0.5 mg/ml oral solution desloratadine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of oral solution contains 0.5 mg desloratadine.

3. LIST OF EXCIPIENTS

Contains propylene glycol and sorbitol.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

oral solution

30 ml with 1 spoon

50 ml with 1 spoon

60 ml with 1 spoon

100 ml with 1 spoon

120 ml with 1 spoon

150 ml with 1 spoon

150 ml with 1 oral syringe

225 ml with 1 spoon

300 ml with 1 spoon

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not freeze. Store in the original package.

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/160/061

30 ml with 1 spoon

 

 

EU/1/00/160/062

50 ml with 1 spoon

 

 

EU/1/00/160/063

60 ml with 1 spoon

 

 

EU/1/00/160/064

100 ml with 1 spoon

 

 

EU/1/00/160/065

120 ml with 1 spoon

 

EU/1/00/160/066

150 ml with 1 spoon

 

EU/1/00/160/069

150 ml with 1 oral

syringe

EU/1/00/160/067

225 ml with 1 spoon

 

EU/1/00/160/068

300 ml with 1 spoon

 

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aerius

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML

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

Aerius 0.5 mg/ml oral solution desloratadine

2.METHOD OF ADMINISTRATION

Oral use

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 ml

50 ml

60 ml

100 ml

120 ml

150 ml

225 ml

300 ml

6.LIST OF EXCIPIENTS

Contains propylene glycol and sorbitol.

See leaflet for further information.

7.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

8. 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.

9. SPECIAL STORAGE CONDITIONS

Do not freeze. Store in the original package.

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