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Kivexa (abacavir / lamivudine) – Labelling - J05AR02

Updated on site: 08-Oct-2017

Medication nameKivexa
ATC CodeJ05AR02
Substanceabacavir / lamivudine
ManufacturerViiV Healthcare UK Limited 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine

3.LIST OF EXCIPIENTS

Contains sunset yellow (E110), see leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

30 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

Detach enclosed Alert Card, it contains important safety information

WARNING! In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY

“Pull here”

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/298/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

kivexa

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer label of 90 (3 packs of 30 film-coated tablets) (with Blue Box) wrapped in clear plastic foil

1. NAME OF THE MEDICINAL PRODUCT

Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains abacavir 600 mg abacavir (as sulfate) and 300 mg lamivudine

3. LIST OF EXCIPIENTS

Contains sunset yellow (E110), see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack containing 90 (3 packs of 30) 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

WARNING! In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/298/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Multipacks of 90 (3 packs of 30 film-coated tablets) – without blue box – OUTER CARTON BLISTER PACK

30 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine

3. LIST OF EXCIPIENTS

Contains sunset yellow (E110), see package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

Component of a multipack, not to 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

Detach enclosed Alert Card, it contains important safety information

WARNING! In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY

“Pull here”

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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

kivexa

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Kivexa 600 mg/300 mg tablets. abacavir/lamivudine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

KIVEXA TABLETS ALERT CARD

SIDE 1

IMPORTANT - ALERT CARD

Kivexa (abacavir / lamivudine) tablets

Carry this card with you at all times

Since Kivexa contains abacavir some patients taking Kivexa may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Kivexa is continued.

CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Kivexa if:

1)you get a skin rash OR

2)you get one or more symptoms from at least TWO of the following groups

-fever

­shortness of breath, sore throat or cough

­nausea or vomiting or diarrhoea or abdominal pain

­severe tiredness or achiness or generally feeling ill

If you have discontinued Kivexa due to this reaction, YOU MUST NEVER TAKE Kivexa, or any medicine containing abacavir (e.g. Ziagen,Triumeq or Trizivir) again as within hours you may experience a life-threatening lowering of your blood pressure or death.

(see reverse of card)

SIDE 2

You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Kivexa. Write your doctor's details below:

Doctor:.......................…………………… Tel:...................…………

If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).

For general Kivexa information enquiries, contact [local company name and telephone number inserted here]

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