Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 16 October 2024
File name
Reg HCP SM 32_1 PIL SM 43_0 IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC change for the MAH name and address, and PRAC update to add a warning regarding Thyrotoxic Periodic Paralysis (TPP).
PIL has also been updated to reflect the address change for the manufacturer from Puurs to Puurs-Sint-Amands.
Updated on 16 October 2024
File name
Reg SPC SM 36_0 1000 mg IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The SPC has been updated as follows:
Section 7 Change of MAH name and address.
Section 4.4: PRAC update – addition of a warning regarding Thyrotoxic Periodic Paralysis (TPP)
Updated on 15 April 2024
File name
Reg SPC SM 35_1 1000mg IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 April 2024
File name
Reg HCP SM 32_1 PIL SM 42_1 IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 November 2023
File name
Reg SPC SM 34_1 1000mg IE clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 September 2023
File name
RegSPCSM 332 1000mg IEclean.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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4: Addition of warning on Tumour Lysis Syndrome (TLS)
Section 4.8: Addition of “Hypothalamic pituitary adrenal axis suppression” as an Endocrine disorder replacing Hypopituitarism.
Updated on 26 September 2023
File name
RegHCPSM 321 PIL SM402 IEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 17 April 2023
File name
Reg SPC SM 32_1 1000mg IE clean.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
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 April 2023
File name
Reg HCP SM 32_1 PIL SM 39_1 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Correction of spelling/typing errors
Updated on 04 August 2022
File name
Reg SPC SM 31_2 1000mg IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 August 2022
File name
Reg HCP SM 31_2 PIL SM 38_1 IE clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Correction of spelling/typing errors
Updated on 06 October 2021
File name
Reg SPC SM 30_1 1000 mg IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: Update to “Excipients with known effect” section in relation to Sodium
Section 4.4: Addition of Excipient Information regarding Sodium
Updated on 06 October 2021
File name
Reg HCP SM 28_1 PIL SM 36_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 08 March 2021
File name
DEC202115579_Reg SPC SM 28_0 1000 mg IE clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
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 Therapeutic indications Removed - severe seasonal and perennial rhinitis |
Updated on 02 March 2021
File name
DEC202113652_Reg SPC SM 27_1 1000 mg IE clean.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 4.4 Special warnings and precautions for use Added - Hypertrophic cardiomyopathy may develop after administration of methylprednisolone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed. Section 4.8 Undesirable effects Updated - updated Irish ADR reporting details in line with v17 Appendix V (Adverse drug reaction reporting details) of the product information template. |
Updated on 02 March 2021
File name
DEC202113652_Reg HCP SM 27_2 PIL SM 32_1 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 26 June 2020
File name
DEC202041893_Reg HCP SM 26_2 PIL SM 28_1 IE clean.pdf
Reasons for updating
- Change to information for healthcare professionals
Updated on 23 June 2020
File name
DEC202041893_Reg SPC SM 25_2 1000 mg IE clean.pdf
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
The SPC has been updated as follows:
Section 4.2 Indication
Dosing for the indication Multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes) updated to
"Administer for 3 or 5 days a dose of either 500 mg/day or 1 g/day as IV pulse dosing over at least 30 minutes."
Updated on 23 June 2020
File name
DEC202041893_Reg HCP SM 26_2 PIL SM 28_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
Updated on 12 December 2019
File name
DEC201961916_Reg HCP SM 25_2 PIL SM 28_1 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 September 2019
File name
DEC201949881_Reg SPC SM 23_3 1000 mg IE clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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
|
The SPC has been updated as follows: Section 6.4 – revised to state This medicinal product does not require any special storage conditions. Section 10 – date of revision of text updated |
Updated on 13 September 2019
File name
DEC201949881_Reg HCP SM 25_2 PIL SM 27_2 IE clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
The PIL and HCP Section has been updated to reflect the SPC changes. See PIL tick list for sections updated.
Updated on 28 November 2018
File name
Reg SPC SM 22_1 1000 mg IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018
File name
Reg_SPC_SM_22_1_1000_mg_IE_clean.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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 4.4 and 4.8 updated to include “blurred vision” warnings
Updated on 30 May 2018
File name
Reg_SPC_SM_22_1_1000_mg_IE_clean.docx
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
The SmPC has been updated as follows:
Sections 4.4 and 4.8 updated to include “blurred vision” warnings
Updated on 21 May 2018
File name
Reg HCP SM 24_0 PIL SM 26_1 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 02 May 2018
File name
Reg_SPC_SM_21_1_1000mg_IE_clean.docx
Reasons for updating
- 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: In section 4.4 detail of scleroderma has been added to the section on Renal and urinary disorders |
Updated on 26 April 2018
File name
Reg HCP 24_0 PIL SM 25_1 IE clean .pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 13 March 2018
File name
PIL_11139_214.pdf
Reasons for updating
- New PIL for new product
Updated on 13 March 2018
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 23 November 2017
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 - excipient warnings
- Change to section 6 - date of revision
Updated on 29 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2017
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
Updates to sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC)
arising from PRAC recommendation 10 November 2016 EMA/PRAC/700146/2016. The updates concern increased risk of systemic side effects when corticosteroids are co-administered with CYP3A inhibitors, including cobicistat containing products.Updated on 27 March 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 19 January 2017
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
• for use by the epidural route of administration.>
Updated on 18 January 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 05 December 2016
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
• for use by the epidural route of administration.>
Updated on 01 December 2016
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 20 September 2016
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to sections 4.4, 4.6, 4.8, 5.2 & 5.3 following CDS update.
Updates to section 4.2 to correct Act-o-Vial usage instructions.
Updated on 19 September 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 12 February 2016
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
The SPC has been updated as follows:
Sections 4.4 and 4.8 have been updated in line with recommended PRAC wording.Updated on 10 February 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 24 August 2015
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
Section 4.8 Undesirable effects
Updated with Thrombosis and Pulmonary embolism
Updated on 02 June 2015
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
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 Posology and method of administration Updated with paediatric population and benzyl alcohol warning Section 4.3 Contraindications Removal of epidural contraindication Section 4.4 Special warnings and precautions for use: Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis Section 4.5 Interaction with other medicinal products and other forms of interaction Interactions updated Section 4.6 Fertility, pregnancy and lactation Benzyl alcohol update Section 4.7 Effects on ability to drive and use machines Updated warning Section 4.8 Undesirable effects: Table updated Section 4.9 Overdose: Updated information Section 5.1 Update to ATC code and therapeutic group Section 5.2 Update to pharmacodynamics data Section 5.3 Update to preclinical data
|
Updated on 28 May 2015
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 28 May 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change to improve clarity and readability
Updated on 21 May 2015
Reasons for updating
- Improved electronic presentation
Updated on 19 May 2015
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
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 Posology and method of administration
Updated with paediatric population and benzyl alcohol warning
Section 4.3 Contraindications
Removal of epidural contraindication
Section 4.4 Special warnings and precautions for use:
Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis
Section 4.5 Interaction with other medicinal products and other forms of interaction
Interactions updated
Section 4.6 Fertility, pregnancy and lactation
Benzyl alcohol update
Section 4.7 Effects on ability to drive and use machines
Updated warning
Section 4.8 Undesirable effects:
Table updated
Section 4.9 Overdose:
Section 5.1
Update to ATC code and therapeutic group
Section 5.2
Update to pharmacodynamics data
Section 5.3
Update to preclinical dataUpdated on 15 May 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change to improve clarity and readability
Updated on 08 January 2015
Reasons for updating
- 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
Please note that the only differences are the version numbers and revision dates.
Updated on 05 January 2015
Reasons for updating
- Change to date of revision
Updated on 06 November 2014
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Correction of spelling/typing errors
Updated on 07 February 2013
Reasons for updating
- Change to product name
Updated on 19 July 2012
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 19 March 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 14 October 2011
Reasons for updating
- Change to marketing authorisation holder
Updated on 15 June 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 30 June 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 24 April 2009
Reasons for updating
- Change to date of revision
Updated on 16 November 2007
Reasons for updating
- Change from the BAN of the active substance to the rINN
Updated on 21 December 2006
Reasons for updating
- Improved electronic presentation
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 26 July 2006
Reasons for updating
- New PIL for medicines.ie