Ziagen Oral Solution 20mg/ml
*Company:
ViiV Healthcare UK LtdStatus:
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 17 July 2024
File name
ie-pl-ziagenos-issue23draft1.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 17 July 2024
File name
ie-spc-ziagenos-issue19draft1.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-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
Amended revision date in previous version
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
EMA - 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
EMA - 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-ziagenos-issue21draft1 med ie.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-ziagenos-issue21draft1 med ie.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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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-ziagenos-issue17draft1 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 13 October 2023
File name
ieukni-spc-combined-ziagenos-issue16draft2_medie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reloading SPC for Ziagen Oral Solution to capture future excipient updates in section 4.4
Updated on 03 October 2023
File name
ieukni-spc-combined-ziagenos-issue16draft1_medie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Updated on 03 October 2023
File name
ieukni-pl-combined-ziagenos-issue20draft1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 11 November 2022
File name
ieukni-pl-combined-ziagenos-issue19draft3 Compendia.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 11 November 2022
File name
ieukni-pl-combined-ziagenos-issue19draft3.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 August 2022
File name
ieukni-spc-combined-ziagenos-issue15draft2_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-ziagenos-issue19draft2-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-ziagenos-issue15draft1_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-ziagenos-issue19draft1_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 - 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-ziagenos-issue18draft1-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 08 April 2021
File name
ie-pl-ziagenos-issue17draft1.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 31 March 2021
File name
ie-pl-ziagenos-issue17draft1-medie.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Correct PIL resinstated following error in removal of updates for Type II WS1917 DDI (DDI riociguat + excipient + syringe update)- approved on the 14 Jan 2021
Updated on 05 March 2021
File name
ie-pl-ziagenos-issue17draft1medie.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-ziagenos-issue16draft1 medie.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- 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-ziagenos-issue14draft1- 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-pl-ziagenos-issue15draft1.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 13 May 2020
File name
ie-spc-ziagenos-issue13draft1.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 21 November 2019
File name
ie-pl-ziagenos-issue14draft1.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Change to section 6 - manufacturer - removal of an inactive BR site.
Updated on 05 February 2019
File name
ie-pl-ziagenos-issue13draft1 for Meds.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 December 2018
File name
ie-pl-ziagenos-issue12draft1 for Meds.ie.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
Updated on 20 December 2018
File name
ie-spc-ziagenos-issue12draft1 for Meds.ie.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
Section 7 updated: MAH transfer
Section 4.8 update: removal of the UK reporting information in the IE SmPC and removal of the IE reporting information in the UK SmPC.
Updated on 18 September 2018
File name
ukie-spc-ziagenos-issue11draft1 - 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-ziagenos.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 March 2018
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- 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 3 SPC - Description of colour of solution over time
Section 6.1 SPC - The flavouring agents used in the formulation, Banana and strawberry flavours, were incorrectly captured as natural and artificial flavours historically and this has been corrected.
Section 4.8 SPC - MHRA reporting details updated in line with Appendix V (EMA).
Updated on 06 March 2018
File name
PIL_11340_864.pdf
Reasons for updating
- New PIL for new product
Updated on 06 March 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
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
- 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 4.2 - 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
- Change to section 4.1 - Therapeutic indications
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 4.6 - Pregnancy and lactation
- 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
Updated on 16 July 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Correction of spelling/typing errors
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
- 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 further information section
- Change to date of revision
- Change of special precautions for disposal
- Correction of spelling/typing errors
Updated on 08 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 28 April 2015
Reasons for updating
- Change of manufacturer
- Change to, or new use for medicine
- Change to date of revision
Updated on 18 March 2015
Reasons for updating
- 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
- Change to section 4.8 - Undesirable effects
- Change to section 4.2 - Posology and method of administration
- 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
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 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
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Section 4.2 Posology & method of Administration
|
Amendment of ‘older patients’ to ‘elderly’
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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
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Section 5.2 Pharmacokinetic properties
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to change "older people" to "elderly"
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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 of the SPC
· The following text was added to section 4.4 of the SPC with regards 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 was added to section 4.8 of the SPC with regards 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 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 31 May 2012
Reasons for updating
- Change of manufacturer
Updated on 21 October 2011
Reasons for updating
- Change of manufacturer
Updated on 20 October 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
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6.5
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 16 August 2010
Reasons for updating
- Change to section 7 - Marketing authorisation holder
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Updated on 07 May 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
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
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Section 4.1 -Therapeutic indications:
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. 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 Kivexa therapy”). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8).
Section 4.4 - Special warnings and precautions for use
…
Hypersensitivity reaction (see also section 4.8 )
In a clinical study, 3.4 % of subjects with a negative HLA-B*5701 status receiving abacavir developed a hypersensitivity reaction.
Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir. Based on the prospective study CNA106030 (PREDICT-1), use of pre-therapy screening for the HLA-B*5701 allele and subsequently avoiding abacavir in patients with this allele significantly reduced the incidence of abacavir hypersensitivity reactions. In populations similar to that enrolled in the PREDICT-1 study, it is estimated that 48% to 61% of patients with the HLA-B*5701 allele will develop a hypersensitivity reaction during the course of abacavir treatment compared with 0% to 4% of patients who do not have the HLA-B*5701 allele.
These results are consistent with those of prior retrospective studies.
As a consequence, before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. 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 Kivexa therapy”). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available based on the treatment history and resistance testing (see section 4.1).
…….
Screening for carriage of the HLA B*5701 allele is recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Re-initiation of abacavir in such patients who test positive for the HLA B*5701 allele is not recommended and should be considered only under exceptional circumstances where potential benefit outweighs the risk and with close medical supervision.
· Essential patient information
Prescribers must ensure that patients are fully informed regarding the following information on the hypersensitivity reaction:
- Patients must be made aware of the possibility of a hypersensitivity reaction to abacavir that may result in a life-threatening reaction or death and that the risk of a hypersensitivity reaction is increased if they are HLA-B*5701 positive.
- Patients must also be informed that a HLA-B*5701 negative patient can also experience an abacavir hypersensitivity reaction. Therefore, ANY patient who develops signs or symptoms consistent with a possible hypersensitivity reaction to abacavir MUST CONTACT THEIR DOCTOR IMMEDIATELY.
- Patients who are hypersensitive to abacavir should be reminded that they must never take Kivexa or any other medicinal product containing abacavir (e.g. Ziagen or Trizivir) again, regardless of their HLA-B*5701 status.
Section 4.8 - Undesirable effects
Abacavir hypersensitivity (see also section 4.4)
In a clinical study, 3.4 % of subjects with a negative HLA-B*5701 status receiving abacavir developed a hypersensitivity reaction. In clinical studies with abacavir 600 mg once daily the reported rate of hypersensitivity remained within the range recorded for abacavir 300 mg twice daily.
Updated on 28 July 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to section 10 - Date of revision of the text
- Change to section 4.3 - Contraindications
- Change to section 4.2 - Posology and method of administration
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Ziagen 20 mg/ml oral solution (EU/1/99/112/002).All changes highlighted in Red
SPC
Section 2
Quantitative description added i.e. ‘Each ml of oral solution contains 20 mg of abacavir (as sulfate).’
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).
Ziagen can be taken with or without food.
Ziagen is also available as a tablet formulation.
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).
Ziagen can be taken with or without food.
Ziagen is also available as a tablet formulation.
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
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Updated on 07 October 2008
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 August 2008
Reasons for updating
- Change to warnings or special precautions for use
- Correction of spelling/typing errors
Updated on 26 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 March 2008
Reasons for updating
- 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 28 August 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2007
Reasons for updating
- Improved electronic presentation
Updated on 05 January 2007
Reasons for updating
- 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 29 August 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 27 July 2006
Reasons for updating
- Improved electronic presentation
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Updated on 19 August 2003
Reasons for updating
- Improved electronic presentation
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Updated on 18 July 2003
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
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