English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Aerinaze (desloratadine / pseudophedrine sulphate) – Labelling - R01BA52

Updated on site: 11-Jul-2017

Medication nameAerinaze
ATC CodeR01BA52
Substancedesloratadine / pseudophedrine sulphate
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Aerinaze 2.5 mg/120 mg modified-release tablets desloratadine/pseudoephedrine sulphate

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

2 modified-release tablets

4 modified-release tablets

7 modified-release tablets

10 modified-release tablets

14 modified-release tablets

20 modified-release tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Swallow the tablet whole with water.

Do not crush, break or chew.

Read the package leaflet before use.

Oral 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.

Keep the blisters in the outer carton 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

Marketing Authorisation Holder:

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/399/001 2 modified-release tablets

EU/1/07/399/002 4 modified-release tablets

EU/1/07/399/003 7 modified-release tablets

EU/1/07/399/004 10 modified-release tablets

EU/1/07/399/005 14 modified-release tablets

EU/1/07/399/006 20 modified-release tablets

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Aerinaze

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Aerinaze 2.5 mg/120 mg modified-release tablets desloratadine/pseudoephedrine sulphate

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 26581

    prescription drugs listed