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ViiV Healthcare UK Ltd
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 24/06/2011
SPC Trizivir film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 24/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 updated to add the information that lamivudine should not be taken with drugs containing lamivudine or emtricitabine

Section 4.5 updated to delete the information as regards the co-administration of lamivudine with ganciclovir or foscarnet

Section 4.6 updated to give a consistent message as regards the clinical experience gained on the use of lamivudine during pregnancy and harmonise the fertility, pregnancy and lactation statement between EPIVIR (revised wording recently adopted by the CHMP) and KIVEXA and TRIZIVIR

Section 4.6 information on Zalcitabine removed

Sections 5.3 clarifications
Section 10 - date of revision
Updated on 21/02/2011 and displayed until 24/06/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3 - typographical change only
Section 4.2 - reference to use in paediatric population not being established / details of method of administration
Section 4.3 - text and typographical changes only – no changes to scope
Section 4.4 - text and typographical changes only – no changes to scope
Section 4.5 - typographical changes only
Section 4.6 - typographical changes only
Section 4.8 - clarifications to safety profile only
Section 4.9 - typographical changes only
Section 5.1 - reference to systemic use
Section 5.2 - typographical changes only
Section 6.5 - typographical changes only
Section 6.6 - typographical changes only
Section 9 - amended renewal date
Section 10 - amended revision date
Updated on 02/08/2010 and displayed until 21/02/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7 - MAH transfer to ViiV – address updates
Section 10 - Date updated
Updated on 14/12/2009 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 -Additional Text;

Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see "Management after an interruption of Trizivir therapy").

Section 4.4 - Various changes to include information recommending screening prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.

Section 4.8 - Changes under hypersensitivity linked to HLA-B*5701

Section 10 - Approval Date; 23 November 2009
Updated on 23/06/2009 and displayed until 14/12/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Additional Text:

 

Myocardial Infarction: Observational studies have shown an association between myocardial infarction and the use of abacavir. Those studied were mainly antiretroviral experienced patients. Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk. Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction. To date, there is no established biological mechanism to explain a potential increase in risk. When prescribing Trizivir, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).

 

Section 10 - Approval date: 27/05/2009

 

 
Updated on 07/04/2009 and displayed until 23/06/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1 - Pharmacotherapeutic group: "nucleoside reverse transcriptase inhibitors" replaced by "Antivirals for treatment of HIV infections, combinations."

 

Section 10 - APPROVAL DATE
Updated on 28/03/2008 and displayed until 07/04/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 4.1 - Advice on screening for carriage of the HLA-B*5701 allele, before treatment with abacavir, to prevent hypersensitivity

Section 4.4 - Advice on screening for carriage of the HLA-B*5701 allele, before treatment with abacavir, to prevent hypersensitivity

Section 10 - Update of date of revision of the text
Updated on 06/12/2007 and displayed until 28/03/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Patients co-infected with hepatitis C virus: Comcomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia

Section 4.4 - The concomitant use of stavudine with zidovudine should be avoided

Section 4.5 - Update to interaction information (probenecid, rifampicin, atovaquone, Valproic acid, methadone, stavudine)

Section 4.5 - Addition of info regarding clarithromycin, fluconazole and stavudine interactions, as well as ribivarin (increased risk of anaemia).
Updated on 21/09/2007 and displayed until 06/12/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

update section 5.1 (Pharmacodynamics) of the SPC regarding M184V resistance and lamivudine, with the addition of the following wording:
"In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness). The clinical relevance of these findings is not established. Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field. In any case, initiation of susceptible NRTIs should always be preferred to maintenance of lamivudine therapy. Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTIs are available."
 
Section 10. 3rd Setember 2007
Updated on 12/06/2007 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1: Updated Resistance information
Section 10: Updated date of revision of text
Updated on 13/02/2007 and displayed until 12/06/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 21/12/2006 and displayed until 13/02/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 26/04/2006 and displayed until 21/12/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   10/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 14/01/2005 and displayed until 26/04/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 09/06/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 24/02/2004 and displayed until 09/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 12/02/2004 and displayed until 24/02/2004
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 17/12/2003 and displayed until 12/02/2004
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 18/08/2003 and displayed until 17/12/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 08/01/2003 and displayed until 18/08/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 19/12/2002 and displayed until 08/01/2003
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 26/11/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 15/11/2002 and displayed until 26/11/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 10/12/2001 and displayed until 15/11/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/12/2001 and displayed until 10/12/2001
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 03/12/2001 and displayed until 05/12/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 10/08/2001 and displayed until 03/12/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 28/03/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lamivudine
  zidovudine
  abacavir sulfate