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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
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Summary of Product Characteristics last updated on the eMC: 16/12/2009
SPC Ziagen 20 mg/ml Oral Solution

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 16/12/2009 and displayed until Current
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:   20-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 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
Updated on 22/06/2009 and displayed until 16/12/2009
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 4.9 - Overdose
  • Change to section 10 date of revision of the text
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


Section 3 - Additional Text:

 

The tablet can be divided into equal halves.

 

Section 4.2 - Amended Text:

 

Children less than three months: the experience in children aged less than three months is limited (see section 5.2)

 

Section 4.3 - Deleted text:

 

Ziagen is contraindicated in patients with

 

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 Ziagen, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Essential patient information
Deleted text: - patients should be advised of the importance of taking Ziagen regularly.
Deleted Text;
Once daily administration (abacavir 600 mg): the benefit of abacavir as a once daily regimen is mainly based on a study performed in combination with efavirenz and lamivudine, in antiretroviral-naïve adult patients (see section 5.1).
Deleted Text:
For patients with severe hepatic impairment, Ziagen is contraindicated (see section 4.3).

 

Section 4.9 - No unexpected adverse reactions were reported.
Replaced by: No additional adverse reactions to those reported for normal doses were reported

 

Section 10 - Approval date: 08/06/2009
Updated on 31/03/2008 and displayed until 22/06/2009
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 07/09/2007 and displayed until 31/03/2008
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
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

To update 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 (AUC24,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)."
 
section 10.  Update to 27 August 2007

 
Updated on 12/06/2007 and displayed until 07/09/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1: Updated resistance section
Updated on 12/02/2007 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 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:   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 20/12/2006 and displayed until 12/02/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • 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 22/12/2005 and displayed until 20/12/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 18/01/2005 and displayed until 22/12/2005
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 05/01/2005 and displayed until 18/01/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 04/06/2004 and displayed until 05/01/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 04/06/2004 and displayed until 04/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Pending awaiting re-submission
Updated on 18/03/2004 and displayed until 04/06/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 26/02/2004 and displayed until 18/03/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/02/2004 and displayed until 26/02/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 11/12/2003 and displayed until 24/02/2004
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 18/08/2003 and displayed until 11/12/2003
Reasons for adding or updating:
  • Addition of Black Triangle
  • Improved Electronic Presentation
Updated on 15/08/2003 and displayed until 18/08/2003
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 10/12/2002 and displayed until 15/08/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 09/12/2002 and displayed until 10/12/2002
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 05/12/2001 and displayed until 09/12/2002
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 06/11/2001 and displayed until 05/12/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 13/07/2001 and displayed until 06/11/2001
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 21/09/2000 and displayed until 13/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 15/02/2000 and displayed until 21/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  abacavir sulfate


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