Dexamethasone Phosphate 4 mg/ml Solution for Injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 22 November 2024
File name
Reg PIL gxDM 17_1 IE - Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
The PIL has been updated in section 4 with statement on hiccups to reflect the SPC changes
Updated on 22 November 2024
File name
Reg SPC gxDM 13_1 IE - Clean.pdf
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
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 4.1, 4.2, 4.3, 4.4, 4.5: Editorial
Section 4.8: Editorial, Hiccups with frequency not known added under Respiratory, thoracic and mediastinal disorders
Section 4.9: Editorial
Updated on 17 October 2024
File name
Reg SPC gxDM 12_0 IE - Clean .pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2024
File name
Reg PIL gxDM 16_0 IE - Clean .pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 04 September 2023
File name
RegSPCgxDM111IEClean (1).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
The SPC has been updated as follows:
Section 4.2 : Editorial
Section 4.4 : Text on fatality of pheochromocytoma crisis included
Updated on 04 September 2023
File name
RegPILgxDM154IEClean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - manufacturer
Updated on 13 February 2023
File name
RegSPCgxDM101IEClean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2022
File name
RegSPCgxDM101IEClean.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.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 .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 .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 .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.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.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.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.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.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.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.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.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.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.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
4.5 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
Updated on 17 August 2017
Reasons for updating
- New PIL for medicines.ie