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Trizivir (abacavir (as sulfate) / lamivudine /...) – Labelling - J05AR04

Updated on site: 10-Oct-2017

Medication nameTrizivir
ATC CodeJ05AR04
Substanceabacavir (as sulfate) / lamivudine / zidovudine
ManufacturerViiV Healthcare UK Limited  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARTON x 60 FILM-COATED TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains: abacavir 300 mg (as sulfate) lamivudine 150 mg

zidovudine 300 mg

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

60 film-coated 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

Detach enclosed Alert Card, it contains important safety information

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

Pull here” (with Alert card attached)

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/1/00/156/002 PCTFE/PVC-Al

EU/1/00/156/004 PVC/PCTFE/PVC-Al/Paper

13.BATCH NUMBER

LOT

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

trizivir

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER x 60 FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Trizivir 300 mg/150 mg/300 mg tablets abacavir/lamivudine/zidovudine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

ViiV Healthcare UK Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

LOT

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON x 60 FILM COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains: abacavir 300 mg (as sulfate) lamivudine 150 mg

zidovudine 300 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated 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

Detach enclosed Alert Card, it contains important safety information

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

Pull here” (with Alert card attached)

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/1/00/156/003

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

trizivir

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL x 60 FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains: abacavir 300 mg (as sulfate) lamivudine 150 mg

zidovudine 300 mg

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

60 film-coated 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 REACHOF 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

ViiV Healthcare UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/00/156/003

13. BATCH NUMBER

LOT

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

TRIZIVIR TABLETS ALERT CARD (blister and bottle pack)

SIDE 1

IMPORTANT - ALERT CARD

TRIZIVIR (abacavir sulfate / lamivudine / zidovudine) Tablets

Carry this card with you at all times

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

CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Trizivir 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 Trizivir due to this reaction, YOU MUST NEVER TAKE Trizivir, or any medicine containing abacavir (Kivexa, Ziagen or Triumeq) 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 Trizivir. 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 Trizivir information enquiries, contact (local company name and telephone number inserted here)

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