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

Janumet (sitagliptin / metformin hydrochloride) – Labelling - A10BD07

Updated on site: 08-Oct-2017

Medication nameJanumet
ATC CodeA10BD07
Substancesitagliptin / metformin hydrochloride
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

56 film-coated tablets

60 film-coated tablets

112 film-coated tablets

168 film-coated tablets

180 film-coated tablets

196 film-coated tablets

50 x 1 film-coated tablets

Multi-pack containing 196 (2 packs of 98) film-coated tablets

Multi-pack containing 168 (2 packs of 84) film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

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.

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/1/08/455/001 14 film-coated tablets

EU/1/08/455/002 28 film-coated tablets

EU/1/08/455/003 56 film-coated tablets

EU/1/08/455/019 60 film-coated tablets

EU/1/08/455/004 112 film-coated tablets

EU/1/08/455/005 168 film-coated tablets

EU/1/08/455/020 180 film-coated tablets

EU/1/08/455/006 196 film-coated tablets

EU/1/08/455/007 50 x 1 film-coated tablets

EU/1/08/455/015 196 (2 x 98) film-coated tablets

EU/1/08/455/017 168 (2 x 84) film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Janumet 50 mg 850 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON for Multi-packs 2 packs – without blue box - 50 mg/850 mg film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

98 film-coated tablets. Component of a multi-pack, can’t be sold separately. 84 film-coated tablets. Component of a multi-pack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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.

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/1/08/455/015

EU/1/08/455/017

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/850 mg tablets sitagliptin/metformin HCl

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

56 film-coated tablets

60 film-coated tablets

112 film-coated tablets

168 film-coated tablets

180 film-coated tablets

196 film-coated tablets

50 x 1 film-coated tablets

Multi-pack containing 196 (2 packs of 98) film-coated tablets

Multi-pack containing 168 (2 packs of 84) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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.

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/1/08/455/008 14 film-coated tablets

EU/1/08/455/009 28 film-coated tablets

EU/1/08/455/010 56 film-coated tablets

EU/1/08/455/021 60 film-coated tablets

EU/1/08/455/011 112 film-coated tablets

EU/1/08/455/012 168 film-coated tablets

EU/1/08/455/022 180 film-coated tablets

EU/1/08/455/013 196 film-coated tablets

EU/1/08/455/014 50 x 1 film-coated tablets

EU/1/08/455/016 196 (2 x 98) film-coated tablets

EU/1/08/455/018 168 (2 x 84) film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Janumet 50 mg 1,000 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON for Multi-packs 2 packs – without blue box - 50 mg/1,000 mg film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

98 film-coated tablets. Component of a multi-pack, can’t be sold separately. 84 film-coated tablets. Component of a multi-pack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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.

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/1/08/455/016

EU/1/08/455/018

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Janumet 50 mg/1,000 mg tablets sitagliptin/metformin HCl

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

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
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed