Updated on 11/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 movement of text; clarifications around patients with chronic hepatitis b or c and abacavir / ribavirin co-administration wording.
Section 4.5 : typo correction and inclusion of anti-viral section
Section 10 : date of revision
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Updated on 24/05/2011 and displayed until 11/11/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 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 10 date of revision
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Updated on 03/09/2010 and displayed until 24/05/2011
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 4.1 - Therapeutic indications
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 28-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.1 - Addition of “(see sections 4.4 and 5.1).”
Section 4.4 - Updated text to read:
Risk of virological failure:
- Triple nucleoside therapy: There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen.
- The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Section 5.1 - Update under section;
Clinical experience; Therapy-naïve patients
Section 10 – Approval date updated
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Updated on 02/08/2010 and displayed until 03/09/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| 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
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| Section 7 - MAH transfer to ViiV – address updates
Section 10 - Date updated
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Updated on 26/01/2010 and displayed until 02/08/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - Minor amendment
Section 4.1 - Removal of paragraph relating to demonstration of benefit of combination therapy and cross ref. to sections 4.4/5.1
Section 4.2 - Children changed to paediatric population
Section 4.3 - Re-worded
Section 4.4 - Minor amendments, and removal of sub-paragraph - clinical studies and excipents section moved to end of section.
Section 4.5 - Removal of paragraph re. zalcitabine
Section 4.7 - Minor amendment
Section 4.8 - Minor amendment
Section 5.1 - Minor amendment
Section 5.2 - Minor amendment
Section 6.5 - Minor amendment
Section 6.6 - Heading updated
Section 9 - Renewal date added
Section 10 - Date Updated
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Updated on 17/12/2009 and displayed until 26/01/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 Ziagen 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; 20 November 2009
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Updated on 17/06/2009 and displayed until 17/12/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 Kivexa, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Section 10 - Approval date: 08/06/2009
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Updated on 31/03/2008 and displayed until 17/06/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| 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
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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
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Updated on 03/12/2007 and displayed until 31/03/2008
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.5: New pack details added
Section 8: New EU number added to represent the new pack
Section 10: Revision date amended
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Updated on 06/09/2007 and displayed until 03/12/2007
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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 5.2 (Pharmacokinetics) of the SPC to include the results from a study evaluating abacavir pharmacokinetics in HIV infected patients (CAL102120 study)"In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC 24,ss + 32 %, Cmax24,ss + 99 % and Ctrough + 18 %) compared to the 300 mg twice daily regimen. Overall, these data support the use of abacavir 600 mg once daily for the treatment of HIV infected patients. Additionally, the efficacy and safety of abacavir given once daily has been demonstrated in a pivotal clinical study (CNA30021- See section 5.1 Clinical experience)."
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Updated on 12/06/2007 and displayed until 06/09/2007
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1: Formating changed for readability
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Updated on 12/06/2007 and displayed until 12/06/2007
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1: Updated resistance section
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Updated on 12/02/2007 and displayed until 12/06/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/02/2007 and displayed until 12/02/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 19/12/2006 and displayed until 12/02/2007
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 03/01/2006 and displayed until 19/12/2006
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Updated on 22/12/2005 and displayed until 03/01/2006
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Pending awaiting re-submission
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Updated on 14/01/2005 and displayed until 22/12/2005
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