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Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial

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Pharmacy Only: Prescription

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

The SPC has been updated as follows: 4.3 Contradictions
•           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

The SPC has been updated as follows: 4.3 Contradictions
•           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

change version code

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 data

Updated 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

Addition of statement to section 4.4 regarding discouraging the use of high doses of corticosteroids to treat traumatic brain injury and correction in section 4.2 from Pneumocystis carinii to Pneumocystis jiroveci

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