Jext 300mcg

*
Pharmacy Only: Prescription
  • Company:

    ALK-Abello Ltd
  • Status:

    No Recent Update
  • Legal 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 04 December 2023

File name

SPC_IE_PA1255-006-002-Jext 300-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 to split packaging from shared with UK. Removal of references to UK reporting

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 looks like and pack contents

Updated on 26 May 2021

File name

jext300-SPC-clean-22032021.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_PA1255-006-002-Jext 300-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-jext300-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-jext300-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 - interactions with other medicines, food or drink
  • 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 4.4 for patients with a thick sub-cutaneous fat layer
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 4.4 for patients with a thick sub-cutaneous fat layer
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

Change in storage conditions to keep below 25°C

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

Change in storage conditions to keep below 25°C

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

Shelf life changed to 18 months from manufacture

Updated on 06 March 2014

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Shelf life changed to 18 months from manufacture

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

In section 6.6, 'Dial 999, ask for ambulance, state anaphylaxis' has been added to step 5 of the administration diagram

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

In section 6.6, 'Dial 999, ask for ambulance, state anaphylaxis' has been added to step 5 of the administration diagram

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

None provided

Updated on 04 January 2012

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided