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Kaletra (lopinavir / ritonavir) – Labelling - J05AR10

Updated on site: 08-Oct-2017

Medication nameKaletra
ATC CodeJ05AR10
Substancelopinavir / ritonavir
ManufacturerAbbVie Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Oral solution - Carton of multipack containing 300 ml (5 bottles 60 ml) oral solution – including blue box

1.NAME OF THE MEDICINAL PRODUCT

Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains: lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).

3.LIST OF EXCIPIENTS

Includes: alcohol, high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).

4.PHARMACEUTICAL FORM AND CONTENTS

Multipack: 300 ml (5 bottles of 60 ml each) oral solution.

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

Child resistant closure

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package.

Avoid exposure to excessive heat.

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/003

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Kaletra (80 mg + 20 mg) / ml

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Oral Solution – Bottle label

1. NAME OF THE MEDICINAL PRODUCT

Kaletra (80 mg + 20 mg) / ml oral solution (lopinavir + ritonavir)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml contains lopinavir 80 mg and ritonavir 20 mg (pharmacokinetic enhancer).

3. LIST OF EXCIPIENTS

Includes: alcohol (42 % v/v see leaflet), high fructose corn syrup, propylene glycol, glycerol, polyoxyl 40 hydrogenated castor oil, potassium (as acesulfame potassium).

4. PHARMACEUTICAL FORM AND CONTENTS

60 ml oral solution

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Important to open

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

Child resistant closure

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

In use storage: If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks). It is advised to write the date of removal from the refrigerator on the package.

Avoid exposure to excessive heat.

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 200 mg/50 mg tablets – Carton of 1 bottle

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

120 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kaletra 200 mg/50 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

200 mg/50 mg Tablets – Carton of multipack containing 360 (3 bottles of 120) film-coated tablets

– including blue box

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 360 (3 bottles of 120) film-coated tablets 3 month pack

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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kaletra 200 mg/50 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 200 mg/50 mg tablets – Bottle label

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

120 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/004

EU/1/01/172/007

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of multipacks of 120 (3 cartons of 40 film-coated 200 mg/50 mg film-coated tablets) - including the blue box

Carton of blister pack containing 120 200 mg/50 mg film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 120 (3 packs of 40) film-coated tablets 120 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/005 – multipack: 120 (3 packs of 40) film-coated tablets

EU/1/01/172/008 – carton of 120 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

Kaletra 200 mg/50 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON

Inner carton of multipack of 120 (3 packs of 40) 200 mg/50 mg film-coated tablets) – without blue box

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

40 film-coated tablets. Component of a multipack, 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kaletra 200 mg/50 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

200 mg/50 mg tablets – Blister of 8 film-coated tablets or Blister of 12 film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 200 mg/50 mg film-coated tablets lopinavir/ritonavir

2.NAME OF THE MARKETING AUTHORISATION HOLDER

AbbVie Ltd

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 100 mg/ 25 mg tablets – Carton of 1 bottle

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kaletra 100 mg/25 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label

1. NAME OF THE MEDICINAL PRODUCT

Kaletra 100 mg/25 mg film-coated tablets lopinavir/ritonavir

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 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

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

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/172/006

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

Not applicable

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

Not applicable

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