Dexamethasone Phosphate 4 mg/ml Solution for Injection *
Pharmacy Only: Prescription

Updated on 26 January 2022

File name

RegSPCgxDM101IEClean_1643194347.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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

PSUSA for Dexamethasone - PSUSA/00000973/202101: CMDh Position suggested label updates to SmPC sections 4.4, 4.6, 4.8 to include warnings on risk of Hypertrophic cardiomyopathy and neonatal hypoglycaemia following administration of Dexamethasone involving neonatal population.

Section 4.4 - warnings on risk of Hypertrophic cardiomyopathy and monitoring of cardiac function in infants

Section 4.6 – Risk of neonatal hypoglycaemia

Section 4.8 – Reference to section 4.4 for cardiac disorders

Updated on 26 January 2022

File name

RegPILgxDM144IEClean_1643194144.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 23 September 2021

File name

DEC202162824_Reg SPC gxDM 9_1 IE - Clean _1632391172.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 4.8 - Undesirable effects
  • 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

The SPC has been updated as follows:

Section 2 – Editorial update

Section 4.2 - Editorial update

Section 4.4 - Addition of Hypertrophic cardiomyopathy, update to mention the effect is temporary and can reverse on withdrawal of treatment, Editorial update

Section 4.8 – Cardiac disorders in prematurely born infants added

Section 6.6 – Update to disposal instructions, Editorial update 

Updated on 23 September 2021

File name

DEC202162824_Reg PIL gxDM 13_1 IE - Clean _1632391104.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 August 2021

File name

DEC202154442_Reg SPC gxDM 7_1 IE - Clean _1628777760.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 August 2021

File name

DEC202154442_Reg PIL gxDM 11_1 IE - Clean_1628777637.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 25 March 2021

File name

DEC202120894_Reg SPC gxDM 5_2 4mg_ml IE clean_1616678296.pdf

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 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 March 2021

File name

DEC202120894_Reg PIL gxDM 10_0 4mg_ml IE clean_1616678249.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 February 2021

File name

DEC202111118_Reg PIL gxDM 8_ 0 IE Clean_1613649011.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 May 2020

File name

DEC202035379_clean Reg SPC gxDM 4_1 4mg_ml IE_1590746165.pdf

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)

Updated on 29 May 2020

File name

DEC202035379_clean Reg PIL gxDM 5_1 4mg_ml IE_1590746083.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 19 September 2019

File name

DEC201951335_clean Reg SPC gxDM 3_1 4mg_ml IE_1568890422.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 6.3 has been updated from “As packaged for sale - 18 months” to “As packaged for sale 24 months”

Updated on 26 September 2018

File name

clean Reg PIL gxDM 4_0 4mg_ml IE_1537949554.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 25 September 2018

File name

clean Reg SPC gxDM 2_1 4mg_ml IE_1537860296.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number

Updated on 19 September 2018

File name

clean Reg PIL gxDM 3_0 4mg_ml IE_1537341725.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 July 2018

File name

CLEAN Reg PIL gxDM 2_0 4mg_ml IE.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • 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 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 13 March 2018

File name

PIL_17263_515.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 March 2018

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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special Warnings – Tumour Lysis Syndrome added
4.5 Interactions – Cotreatment with CYP3A inhibitors is expected to increase side effects
4.8 Undesirable Effects – Addition of the eye disorder chorioretinopathy

Updated on 13 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 August 2017

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 August 2017

Reasons for updating

  • New PIL for medicines.ie