Ziagen Film-Coated Tablets 300mg
*Company:
ViiV Healthcare BVStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 July 2024
File name
ie-pl-ziagentabs-issue17draft1.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 29 July 2024
File name
ie-spc-ziagentabs-issue17draft1.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2024
File name
ieukni-spc-combined-ziagentabs-issue16draft1.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Presentation Ziagen Tablets updated instead of Ziagen Oral Solution in error - this was rectified immediately and previous document restored.
Updated on 17 January 2024
File name
ieukni-pl-combined-ziagentabs-issue16draft1.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Presentation Ziagen Tablets updated instead of Ziagen Oral Solution in error - this was rectified immediately and previous document restored.
Updated on 17 January 2024
File name
ieukni-spc-combined-ziagenos-issue18draft1.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IB - Update to the storage conditions from ‘Store at or below 30C’ to ‘Store at or below 25C'
Updated on 17 January 2024
File name
ieukni-pl-combined-ziagenos-issue22draft1.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Free text change information supplied by the pharmaceutical company
Type IB - Update to the storage conditions from ‘Store at or below 30C’ to ‘Store at or below 25C'
Updated on 24 November 2023
File name
ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 24 November 2023
File name
ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 24 November 2023
File name
ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 24 November 2023
File name
ieukni-pl-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 24 November 2023
File name
ieukni-spc-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 24 November 2023
File name
ieukni-spc-combined-ziagentabs-issue16draft1 medie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 and Article 107g(3) of Directive 2001/83/EC the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus the variation to the terms of the marketing authorisation(s) for the medicinal products containing the above referred active substance(s), concerning the following change(s):
Update of section 4.4 of the SmPC to add a warning/precaution regarding cardiovascular events. The Package leaflet is updated accordingly.
Updated on 03 October 2023
File name
ieukni-pl-combined-ziagentabs-issue15draft1.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 03 October 2023
File name
ieukni-spc-combined-ziagentabs-issue15draft1_medie.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 November 2022
File name
ieukni-pl-combined-ziagentabs-issue14draft3 Compendia.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 11 November 2022
File name
ieukni-pl-combined-ziagentabs-issue14draft3.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 August 2022
File name
ieukni-spc-combined-ziagentabs-issue14draft2-medie.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Further updates to Breastfeeding wording.
Updated on 25 August 2022
File name
ieukni-pl-combined-ziagentabs-issue14draft2-emc-medie.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Further updates to Breastfeeding wording.
Updated on 08 July 2022
File name
ieukni-spc-combined-ziagentabs-issue14draft1_medie.pdf
Reasons for updating
- 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 - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Presentation impacted: Ziagen 300 mg film-coated tablets- EU/1/99/112/001
Type IAIN - Variation for the name change of the Poznan site (responsible for manufacturing, packaging, QC testing and batch release of the finished product) from GlaxoSmithKline Pharmaceutical S.A. to Delpharm Poznań Spółka Akcyjna
Section 6 of the PIL - Manufacturer has been impacted.
and
Presentation impacted: Ziagen 20 mg/ml oral solution- EU/1/99/112/002 and Ziagen 300 mg film-coated tablets- EU/1/99/112/001
Type IAIN variation for CHMP adopted update to the product information for all approved HIV products, recommending the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.
SPC and PIL impacted refer to attached product information for updates.
Updated on 08 July 2022
File name
ieukni-pl-combined-ziagentabs-issue14draft1_eMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Presentation impacted: Ziagen 300 mg film-coated tablets- EU/1/99/112/001
Type IAIN - Variation for the name change of the Poznan site (responsible for manufacturing, packaging, QC testing and batch release of the finished product) from GlaxoSmithKline Pharmaceutical S.A. to Delpharm Poznań Spółka Akcyjna
Section 6 of the PIL - Manufacturer has been impacted.
and
Presentation impacted: Ziagen 20 mg/ml oral solution- EU/1/99/112/002 and Ziagen 300 mg film-coated tablets- EU/1/99/112/001
Type IAIN variation for CHMP adopted update to the product information for all approved HIV products, recommending the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.
SPC and PIL impacted refer to attached product information for updates.
Updated on 10 December 2021
File name
ieukni-pl-combined-ziagentabs-issue13draft1-compendia.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 05 March 2021
File name
ie-pl-ziagentabs-issue12draft1medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Removal of Inactive UK Finished Product Batch Release Site
Updated on 20 January 2021
File name
ie-pl-ziagentabs-issue11draft1- medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
| Type II variation, following a worksharing procedure to update the section 4.5 of the SmPC and section 2 of the package leaflet with new information about the drug-drug interactions between abacavir and riociguat.Furthermore, the MAH took the opportunity to introduce an excipient update for Ziagen in line with the SmPC guideline, a syringe instruction update in the Package Leaflet of Ziagen.Moreover, minor editorial updates have been introduced throughout the Product Information. |
Updated on 20 January 2021
File name
ie-spc-ziagentabs-issue13draft1- med ie.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
| Type II variation, following a worksharing procedure to update the section 4.5 of the SmPC and section 2 of the package leaflet with new information about the drug-drug interactions between abacavir and riociguat.Furthermore, the MAH took the opportunity to introduce an excipient update for Ziagen in line with the SmPC guideline, a syringe instruction update in the Package Leaflet of Ziagen.Moreover, minor editorial updates have been introduced throughout the Product Information. |
Updated on 13 May 2020
File name
ie-spc-ziagentabs-issue12draft1.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Change in the address of the Marketing Aurthorisation Holder.
- Update to the reporting details for the HPRA
Updated on 13 May 2020
File name
ie-pl-ziagentabs-issue10draft1.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Change in the address of the Marketing Aurthorisation Holder.
- Update to the reporting details for the HPRA.
Updated on 18 September 2018
File name
ukie-spc-ziagentabs-issue10draft1 Meds ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC Section 4.4 Warnings “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.”
SmPC Section 4.8 Undesirable events “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4)”
Updated on 01 June 2018
File name
ukie-spc-ziagentabs.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2017
File name
PIL_9917_443.pdf
Reasons for updating
- New PIL for new product
Updated on 13 June 2017
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 28 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2016
Reasons for 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 July 2016
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 13 April 2016
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC section 4.4 - Mitochondrial dysfunction following exposure in utero.
Updated on 12 April 2016
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 09 February 2016
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 25 September 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 – antiviral activity update
Updated on 27 July 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of sections 4.1, 4.2, 4.3, 4.4 and 4.8 of the SmPC to revise the information on hypersensitivity reactions
Updated on 23 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 16 July 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Section 4.6 of SmPC to include WHO Breast-feeding guidance
Update to section 6.5 to add child-resistant blister
Updated on 15 July 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 14 July 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of sections 4.1, 4.2, 4.3, 4.4 and 4.8 of the SmPC to revise the information on hypersensitivity reactions
Updated on 13 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to marketing authorisation holder
- Change of special precautions for disposal
- Correction of spelling/typing errors
Updated on 07 May 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 May 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Correction of spelling/typing errors
Updated on 19 March 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Update to Posology (dosing in paediatrics)
Section 4.6 correction of typo – “secreted” deleted
Section 4.8 Inclusion of Arrow trial data
Section 5.1 Inclusion of heading “Resistance” and “Clinical efficacy and safety”; inclusion of trial data in paeds
Section 5.2 added further information under “Special populations” (use in paeds)
Section 9 “Date of latest renewal” updated
Updated on 18 March 2015
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
- Change to dosage and administration
Updated on 16 April 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
Section 4.1 Therapeutic indications |
Minor update to include statement "in adults and children." in therapeutic indications
|
|
Section 4.2 Posology & method of Administration
|
Minor grammatical updates to the SPC section 4.2 dosing in paediatric patients; Amendment of ‘older patients’ to ‘elderly’
|
|
Section 4.4 Special Warnings & precautions for use
|
Update to wording of how to manage after an interruption to Ziagen therapy & risk of transmission
|
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Section 4.6 Fertility, pregnancy & lactation
|
Update to clinical data on use of abacavir in pregnancy, breast-feeding, fertility
|
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Section 4.8 Undesirable effects
|
Update to wording of reporting of side effects
|
|
Section 5.2 Pharmacokinetic properties
|
Minor update to the SPC Section 5.2 paediatrics sub-section, to align with Ziagen Oral Solution & to change "older people" to "elderly"
|
Updated on 14 October 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects
Updated on 11 October 2013
Reasons for updating
- Change to side-effects
- Change to MA holder contact details
Updated on 05 April 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· There are a number of editorial changes in sections 2, 4.3, 4.6, 5.2, 6.3, 6.6, 9 and 10
· The following text has been added to section 4.4 in relation to autoimmune disorders
Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
· The following text has been added to section 4.8 in relation to autoimmune disordersAutoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment
Updated on 04 April 2013
Reasons for updating
- Change to side-effects
Updated on 12 June 2012
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated on 24 February 2011
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 25 November 2010
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 13 August 2010
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 March 2010
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Important safety update regarding recommendations for HLA-B*5701 screening and reinitiation of abacavir - 'Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir ..
Section 4.1Therapeutic Indictaion
Sevtion 4.4 Special Warning and Precautions for use
Section 4.8 Undesirable Effects
Updated on 22 July 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Ziagen 300 mg film-coated tablets (EU/1/99/112/001)
SPC Changes in Red
Section 3
Added description in brackets ‘(tablets)’
Added statement ‘The tablet can be divided into equal halves.’
Section 4.2
The following paragraphs changed from:
Children less than three months: the data available on the use of Ziagen in this age group are very limited (see section 5.2).
Renal impairment: no dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen should be avoided in patients with end-stage renal disease (see section 5.2).
Hepatic impairment: abacavir is primarily metabolised by the liver. No dose recommendation can be made in patients with mild hepatic impairment. No data are available in patients with moderate hepatic impairment, therefore the use of abacavir is not recommended unless judged necessary. In patients with mild and moderate hepatic impairment close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see section 5.2). Abacavir is contraindicated in patients with severe hepatic impairment (see section 4.3 and 4.4).
to:
Children less than three months: the experience in children aged less than three months is limited (see section 5.2).
Renal impairment: no dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).
Hepatic impairment: abacavir is primarily metabolised by the liver. No dose recommendation can be made in patients with mild hepatic impairment. In patients with moderate hepatic impairment, no data are available, therefore the use of abacavir is not recommended unless judged necessary. If abacavir is used in patients with mild or moderate hepatic impairment, then close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see section 5.2). Abacavir is contraindicated in patients with severe hepatic impairment (see section 4.3 and 4.4).
Section 4.3
Deleted unnecessary detail: ‘Ziagen is contraindicated…’
Changed description ‘adverse events’ to ‘adverse reactions’.
Under the subheading ‘Pancreatitis’ changed description from ‘Ziagen’ to ‘abacavir’
Deleted the following paragraph:
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 the following sentence:
‘For patients with severe hepatic impairment, Ziagen is contraindicated (see section 4.3).’
Under the subheading ‘Osteonecrosis’, changed spelling ‘etiology’ to ‘aetiology’
Section 4.4
Added the following paragraph:
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).
Section 4.9
Changed sentence from ‘No unexpected adverse reactions were reported. The effects of higher doses are not known’ to ‘No additional adverse reactions to those reported for normal doses were reported’
Section 6.6
Heading changed to delete ‘and other handling’
Section 10
Changed to 08 June 2009
Updated on 29 October 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 October 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following text has been added:
4.2 Posology and method of administration
………..
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
5.2 Pharmacokinetic properties
…………………
Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect. This conclusion is based on the physiochemical and pharmacokinetic data, assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Updated on 07 October 2008
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- Change to dosage and administration
Updated on 05 September 2008
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- Change to warnings or special precautions for use
- Correction of spelling/typing errors
Updated on 27 August 2008
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- Change to warnings or special precautions for use
- Correction of spelling/typing errors
Updated on 26 August 2008
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- Improved electronic presentation
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Updated on 27 March 2008
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- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
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Before initiating treatment with abacavir, screening for carriage of HLA-B*5701 should be performed in any HIV-infected patient, irrespective of racial origin.
Abacavir should not be used in patients known to carry HLA-B*5701, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.
Updated on 03 March 2008
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- Improved electronic presentation
Updated on 29 August 2007
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- Improved electronic presentation
Updated on 28 August 2007
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- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2007
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- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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Section 4.4
· Risk Factors
Analyses of clinical risk factors for hypersensitivity to abacavir have consistently identified the risk for those of black race to be approximately half the risk of other racial groups combined. As this still represents a significant risk (based on the fact that approximately 5% of subjects receiving abacavir develop a hypersensitivity reaction in clinical studies), the same close monitoring should apply to patients of all racial groups.
In addition, two retrospective, case-controlled pharmacogenetic studies have shown that carriage of HLA-B*5701 is associated with a significantly increased risk of clinically suspected hypersensitivity in Caucasians. It is estimated that approximately 50% of patients with the HLA-B*5701 allele develop a suspected hypersensitivity reaction (HSR) during the course of abacavir treatment versus less than 3% of patients who do not have HLA-B*5701 allele in the Caucasian population. This genetic association has not been assessed in prospective controlled clinical studies but such studies are ongoing to better appreciate the association between occurrence of HSR and carriage of HLA-B*5701 allele. However, it is noteworthy that among patients with a suspected hypersensitivity reaction, 50% did not carry HLA-B*5701 in the Caucasian population. Therefore, the clinical diagnosis of suspected hypersensitivity to abacavir must remain the basis for clinical decision-making. It is important to permanently discontinue abacavir and not rechallenge with abacavir if hypersensitivity cannot be ruled out on clinical grounds. Absence of the HLA-B*5701 allele does not justify rechallenge with abacavir due to the potential for a fatal rechallenge reaction. The same recommendation should apply for other races and ethnic groups, although data are more limited in these groups.
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Section 4.8:
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). The frequency of this is unknown (see section 4.4).
Updated on 27 July 2006
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- Improved electronic presentation
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Updated on 03 July 2006
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- Change to date of revision
Updated on 04 August 2005
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- Improved electronic presentation
Updated on 31 May 2005
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- New PIL for medicines.ie
Updated on 19 August 2003
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- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2003
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- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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Updated on 01 July 2003
Reasons for updating
- New SPC for medicines.ie
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