Epivir Oral Solution 10mg/ml
*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 17 July 2024
File name
ie-pl-epiviros-issue18draft1.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 17 July 2024
File name
ie-spc-epiviros-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 July 2024
File name
ieukni-spc-combined-epiviros-issue16draft2-clean.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 01 November 2022
File name
ieukni-pl-combined-epiviros-issue17draft3-clean-no header.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update revision date.
Updated on 26 August 2022
File name
ieukni-spc-combined-epiviros-issue16draft2-clean.pdf
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)
Updated on 26 August 2022
File name
ieukni-pl-combined-epiviros-issue17draft2-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 01 July 2022
File name
ieukni-spc-combined-epiviros-issue16draft1.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2022
File name
ieukni-pl-combined-epiviros-issue17draft1.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 date of revision
Updated on 05 October 2021
File name
ieukni-pl-combined-epiviros-issue16draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 06 July 2021
File name
ie-spc-epiviros-issue15draft1.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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
| SPC: Section 4.9 - Overdose information |
Updated on 06 July 2021
File name
ie-pl-epiviros-issue15draft1.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Updated on 10 March 2021
File name
ie-spc-epiviros-issiue14draft1.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 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 2: Update to amount of sodium in 15 ml dose
Section 4.4: Addition of excipient warning for sodium
Section 5.2: Update to lamivudine elimination half-life
Updated on 10 March 2021
File name
ie-pl-epiviros-issue14draft1.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 03 March 2021
File name
ie-pl-epiviros-issue13draft1.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 13 May 2020
File name
ie-pl-epiviros-issue12draft1.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.
Updated on 13 May 2020
File name
ie-spc-epiviros-issue13draft1.pdf
Reasons for updating
- 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 of the address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.
Updated on 25 February 2020
File name
ie-pl-epiviros-issue11draft1.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 Batch Release site. Please note that this update does not impact the leaflet that is in the packs (i.e. the mockups that is supplied with the pack) as only the active manufacturing site is stated on the leaflet mockup.
Updated on 25 February 2020
File name
ie-pl-epiviros-issue11draft1.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 February 2019
File name
ie-pl-epiviros-issue10draft1 - Meds ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - use in children/adolescents
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 26 February 2019
File name
ie-spc-epiviros-issue12draft1 - Meds ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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 14 February 2019
File name
ie-epiviros-issue9draft1-MED.IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 January 2019
File name
ie-pl-epiviros-issue8draft1 - 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 10 January 2019
File name
ie-spc-epiviros-issue11draft1 - 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)
Updated on 17 September 2018
File name
ukie-spc-epiviros-issue10draft1 for 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 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 18 May 2018
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
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 22 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 22 March 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 4.2 updated to recommend a 25% dose increase in children from 8 to 10 mg/kg/day.
Section 4.4 updated to add information regarding the interaction between lamivudine and sorbitol based on the results of Study 204857.
A minor amendment has been implemented in Section 4.4 and 4.5 to update the clinical terminology for ‘Pneumocystis carinii pneumonia’ to ‘Pneumocystis jiroveci pneumonia’.
Section 4.5 updated to add information regarding the interaction between lamivudine and sorbitol based on the results of Study 204857.
Section 4.8: MHRA reporting details has been updated to bring in line with EMA Appendix V.
Updated on 21 March 2018
File name
PIL_10250_262.pdf
Reasons for updating
- New PIL for new product
Updated on 21 March 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- 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 15 July 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- Improved electronic presentation
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update of sections 4.2, 4.4, 5.1 and 5.2 of the SmPC in order to add an administration recommendation, a warning regarding lower efficacy with the Epivir oral solution compared to Epivir tablets as well as efficacy and resistance data from a supplemental analysis of the ARROW study.
In addition, the Marketing authorisation holder (MAH) took the opportunity to make minor editorial changes in the SmPC.
Updated on 14 April 2016
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
Updated on 13 April 2016
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 03 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 02 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 28 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 11 May 2015
Reasons for updating
- 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
Updated on 08 May 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 28 April 2015
Reasons for updating
- Change of manufacturer
- Change to, or new use for medicine
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 18 March 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Description of change to SPC:
Section 4.2 Update to Posology (dosing in paediatrics)
Section 4.8 Inclusion of Arrow trial data
Section 5.1 Inclusion of headings “Mechanism of action” and “Resistance” and “Clinical efficacy and safety”; inclusion of trial data
Section 5.2 Update to absorption data and added further information under “Special populations”
Updated on 18 March 2015
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 31 October 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 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
Description of change to SPC:
· Update to section 4.2 – dosing in elderly
· Update to section 4.6 of the SmPC to reflect updated exposure data relating to the use of lamivudine in the treatment of HIV-1 in pregnant women. In addition the MAH took the opportunity to include a warning in section 4.5 of the SmPC regarding D/I with cytidine analogues and other medicinal products containing lamivudine, in line with existing warning in section 4.4.
Updated on 31 October 2014
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 15 May 2014
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
Update to section 10 for date of revision of the text.
Updated on 12 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 13 January 2014
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 January 2014
Reasons for updating
- Change to MA holder contact details
Updated on 17 May 2013
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
· The following text was added to section 4.4 of the SPC with regards to cladribine
The combination of lamivudine with cladribine is not-recommended (see section 4.5).
· The following text was added to section 4.5 of the SPC with regards to autoimmune disorders
In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also support a possible interaction between lamivudine and cladribine. Therefore, the concomitant use of lamivudine with cladribine is not recommended (see section 4.4).
· The approval date was updated in section 10
Updated on 16 May 2013
Reasons for updating
- Change to drug interactions
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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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, 6.6 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 these events 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 21 February 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 October 2011
Reasons for updating
- Change of manufacturer
Updated on 23 February 2011
Reasons for updating
- Change to side-effects
- Change due to harmonisation of patient information leaflet
Updated on 27 January 2011
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
4.8 Undesirable effects
· Updated the format of the frequency categorisation
· Added angiodema as a rare side effect
Updated on 02 December 2010
Reasons for updating
- Change to marketing authorisation holder
Updated on 16 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 08 January 2010
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 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
Changes:
Addition in red, deletion in blue
4.4 Special warnings and precautions for use
Epivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults
Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently. Epivir is therefore not recommended to be used in combination with zalcitabine.
Co-administration of lamivudine with intravenous ganciclovir or foscarnet is not recommended.
(e.g. didanosine and zalcitabine) like
4.6 Pregnancy and lactation
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative toxicity. Epivir can be used during pregnancy if clinically needed.
For patients co-infected with hepatitis who are being treated with lamivudine and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Mitochondrial dysfunction:
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Pregnancy: The safety of lamivudine in human pregnancy has not been established. Reproductive studies in animals have not shown evidence of teratogenicity, and showed no effect on male or female fertility. Lamivudine induces early embryonic death when administered to pregnant rabbits at exposure levels comparable to those achieved in man. In humans, consistent with passive transmission of lamivudine across the placenta, lamivudine concentrations in infant serum at birth were similar to those in maternal and cord serum at delivery.
Although animal reproductive studies are not always predictive of the human response, administration is not recommended during the first three months of pregnancy.
Lactation:
Updated on 30 October 2008
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
5.1 regarding M184V resistance.
Updated on 22 October 2008
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
- Change to improve clarity and readability
Updated on 02 September 2008
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
- Change to improve clarity and readability
Updated on 04 April 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of the following to section 4.2
Duration of treatment:
In patients with HBeAg positive chronic hepatitis B (CHB) treatment should be administered for at least 3-6 months afterHBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion. This recommendation is based on limited data (see section 5.1).
Addition of the following wording to section 5.1:
Following HBeAg seroconversion, serologic response and clinical remission are generally durable after stopping lamivudine. However, relapse following seroconversion can occur. In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39% of the subjects. Therefore, following HBeAg seroconversion, patients should be periodically monitored to determine that serologic and clinical responses are being maintained. In patients who do not maintain a sustained serological response, consideration should be given to retreatment with either lamivudine or an alternative antiviral agent for resumption of clinical control of HBV.
Updated on 04 April 2007
Reasons for updating
- Improved electronic presentation
Updated on 12 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 20 February 2007
Reasons for updating
- 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
Section 4.4 Addition of following:
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, Addition of following:
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (cART). The frequency of which is unknown (see section 4.4).
Updated on 26 September 2006
Reasons for updating
- Improved electronic presentation
Updated on 16 August 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)