Jext 150mcg
*Company:
ALK-Abello LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 December 2024
File name
SmPC 150-IE-JEXT-26Nov2024.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 December 2023
File name
SPC_IE_PA1255-006-001-Jext 150_Nov2023.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes primarily as packaging is no longer shared with UK so references to UK reporting removed.
Updated on 04 December 2023
File name
PIL_IE_Jext_Nov2023.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 26 May 2021
File name
jext150-SPC-clean-31032021.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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 June 2020
File name
SPC_IE_PA1255-006-001-Jext 150_May2020.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 December 2018
File name
uk-ie-leaflet-mockup-0025.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 19 December 2018
File name
1311-v6-jext150-ie-var0025-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 June 2018
File name
1311-v5-jext150-ie-var0024-cl.docx
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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 updated to include immobilisation of the leg to reduce the risk of laceration
Section 4.5 updated to include thyroid hormones, theophylline, oxytocin, parasympatholytics, diphenhydramine, chlorpheniramine, levodopa and alcohol
Section 6.6 updated to include new diagrams
Updated on 29 June 2018
File name
PIL_UKIE_Jext_Jun18.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Updated on 22 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 November 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to 6.6 educational materials
Updated on 22 November 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
Changes to 6.6 educational materials
Updated on 09 November 2016
File name
PIL_15248_412.pdf
Reasons for updating
- New PIL for new product
Updated on 23 November 2015
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 November 2015
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2013
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2013
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2012
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2012
Reasons for updating
- New SPC for new product